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U.S. Department of Health and Human Services

Class 2 Device Recall HeartWare Ventricular Assist Device System

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  Class 2 Device Recall HeartWare Ventricular Assist Device System see related information
Date Initiated by Firm March 30, 2022
Create Date May 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-1110-2022
Recall Event ID 89967
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001
Code Information Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW29211, HW29212, HW29219, HW29229, HW29246, HW29248, HW29249, HW29252, HW29265, HW29266, HW29268, HW29271, HW29273, HW29274, HW29276, HW29279, HW29282, HW29283, HW29284, HW29285, HW29286, HW29287, HW29290, HW29293, HW29302, HW29309, HW29310, HW29329, HW29333, HW29387, HW29426, HW29465, HW29472, HW29485, HW29502, HW29503, HW29522, HW29526, HW29532, HW29533, HW29534, HW29535, HW29536, HW29538, HW29539, HW29540, HW29541, HW29542, HW29543, HW29546, HW29547, HW29548, HW29549, HW29551, HW29552, HW29562, HW29567, HW29579, HW29583, HW29586, HW29587, HW29588, HW29589, HW29590, HW29592, HW29593, HW29594, HW29595, HW29600, HW29602, HW29603, HW29604, HW29612, HW29629, HW29635, HW29650, HW29660, HW29661, HW29664, HW29665, HW29666, HW29667, HW29668, HW29669, HW29670, HW29671, HW29672, HW29673, HW29674, HW29675, HW29676, HW29685, HW29686, HW29687, HW29700, HW29701, HW29702, HW29717, HW29727, HW29741, HW29754, HW29755, HW29764, HW29776, HW29780, HW29781, HW29782, HW29784, HW29786, HW29787, HW29788, HW29790, HW29791, HW29798, HW29815, HW29820, HW29825, HW29832, HW29836, HW29850, HW29866, HW29867, HW29873, HW29877, HW29887, HW29894, HW29895, HW29896, HW29900, HW29903, HW29904, HW29909, HW29911, HW29915, HW29922, HW29923, HW29927, HW29928, HW29932, HW29949, HW29965, HW29976, HW29983, HW29990, HW29995, HW30038, HW30039, HW30040, HW30079, HW30080, HW30081, HW30082, HW30083, HW30084, HW30085, HW30086, HW30087, HW30088, HW30089, HW30102, HW30103, HW30104, HW30105, HW30106, HW30107, HW30108, HW30109, HW30110, HW30111, HW30112, HW30113, HW30115, HW30116, HW30117, HW30118, HW30147, HW30148, HW30149, HW30150, HW30151, HW30152, HW30153, HW30154, HW30155, HW30156, HW30157, HW30178, HW30193, HW30194, HW30195, HW30196, HW30197, HW30198, HW30199, HW30200, HW30201, HW30202, HW30204, HW30205, HW30207, HW30208, HW30209, HW30210, HW30211, HW30212, HW30213, HW30214, HW30224, HW30225, HW30226, HW30227, HW30231, HW30267, HW30319, HW30320, HW30342, HW30358, HW30360, HW30363, HW30364, HW30365, HW30366, HW30367, HW30369, HW30370, HW30372, HW30376, HW30378, HW30380, HW30382, HW30383, HW30384, HW30385, HW30387, HW30390, HW30392, HW30393, HW30397, HW30398, HW30399, HW30400, HW30402, HW30404, HW30406, HW30407, HW30408, HW30409, HW30410, HW30430, HW30449, HW30455, HW30461, HW30462, HW30463, HW30471, HW30472, HW30473, HW30475, HW30483, HW30484, HW30485, HW30486, HW30491, HW30494, HW30498, HW30595, HW30596, HW30597, HW30598, HW30599, HW30600, HW30601, HW30602, HW30603, HW30604, HW30606, HW30607, HW30608, HW30651, HW30652, HW30654, HW30656, HW30768, HW30769, HW30770, HW30771, HW30808, HW30809, HW30810, HW30811, HW30813, HW30814, HW30815, HW30816, HW30818, HW30820, HW30821, HW30822, HW30823, HW30824, HW30825, HW30829, HW30830, HW30863, HW30864, HW30865, HW30866, HW30867, HW30868, HW30869, HW30870, HW30871, HW30953, HW30954, HW30955, HW30956, HW30957, HW30958, HW30959, HW30960, HW30961, HW30962, HW30963, HW30964, HW30966, HW30967, HW30968, HW30970, HW30971, HW30972, HW30973, HW30974, HW30976, HW31015, HW31020, HW31072, HW31076, HW31087, HW31101, HW31103, HW31104, HW31105, HW31107, HW31111, HW31113, HW31114, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31226, HW31228, HW31232, HW31235, HW31242, HW31244, HW31249, HW31251, HW31254, HW31255, HW31258, HW31260, HW31261, HW31262, HW31267, HW31383, HW31386, HW31387, HW31388, HW31390, HW31398, HW31399, HW31402, HW31409, HW31410, HW31411, HW31412, HW31414, HW31445, HW31446, HW31447, HW31448, HW31449, HW31451, HW31452, HW31453, HW31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731, HW29208R01, HW29209R01, HW29225R01, HW29226R01, HW29241R01, HW29242R01, HW29245R01, HW29247R01; GTIN 00888707003063, Serial Numbers: HW41903, HW41911, HW41924, HW41925, HW41926, HW41927, HW41928, HW41929, HW41950, HW41953, HW42004, HW42006, HW42007, HW42008, HW42018, HW42019, HW42089, HW42158, HW42160, HW42161, HW42219, HW42230, HW42235, HW42237, HW42238, HW42650, HW42651, HW42678, HW42720, HW42724, HW42790, HW42793, HW42797, HW42829, HW42831, HW43009; GTIN 00888707003070, Serial Numbers: HW41892, HW41894, HW41895, HW41897, HW41899, HW41900, HW41901, HW41932, HW41934, HW41936, HW41937, HW41938, HW41939, HW41940, HW41941, HW41971, HW41972, HW41973, HW41974, HW41975, HW41977, HW41986, HW41991, HW41993, HW41994, HW41997, HW42000, HW42001, HW42002, HW42005, HW42009, HW42021, HW42022, HW42026, HW42099, HW42101, HW42103, HW42104, HW42110, HW42111, HW42114, HW42116, HW42148, HW42153, HW42155, HW42157, HW42223, HW42225, HW42228, HW42229, HW42232, HW42233, HW42252, HW42291, HW42307, HW42326, HW42328, HW42329, HW42330, HW42331, HW42332, HW42333, HW42500, HW42666, HW42915; GTIN 00888707003100, Serial Numbers: HW41961, HW41962, HW41964, HW41965, HW41966, HW41967, HW41968, HW42313, HW42660, HW42663, HW42671, HW42672, HW42901; GTIN 00888707003117, Serial Numbers: HW41955, HW41957, HW41958, HW41959, HW41960, HW42023, HW42024, HW42025, HW42061, HW42091, HW42130, HW42292, HW42335, HW42337, HW42339, HW42647, HW42665; GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990; GTIN 00888707003254, Serial Numbers: HW41943, HW41944, HW42213; GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997; GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35562, HW35571, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36006, HW36007, HW36008, HW36009, HW36010, HW36013, HW36018, HW36019, HW36020, HW36021, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36633, HW36636, HW36637, HW36654, HW36655, HW36659, HW36660, HW36662, HW36664, HW36669, HW36670, HW36671, HW36672, HW36673, HW36677, HW36678, HW36680, HW36681, HW36683, HW36685, HW36702, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36718, HW36719, HW36720, HW36722, HW36723, HW36724, HW36725, HW36726, HW36727, HW36728, HW36750, HW36752, HW36753, HW36754, HW36755, HW36785, HW36786, HW36788, HW36789, HW36812, HW36813, HW36815, HW36816, HW36817, HW36818, HW36823, HW36827, HW36829, HW36830, HW36831, HW36832, HW36833, HW36834, HW36835, HW36836, HW36837, HW36839, HW36840, HW36853, HW36854, HW36855, HW36877, HW36881, HW36882, HW36883, HW36891, HW36897, HW36898, HW36899, HW36900, HW36901, HW36902, HW36919, HW36936, HW36937, HW36940, HW36942, HW36944, HW36945, HW36964, HW36966, HW36969, HW36982, HW36988, HW36996, HW36997, HW36999, HW37000, HW37002, HW37005, HW37184, HW37185, HW37186, HW37187, HW37188, HW37189, HW37190, HW37193, HW37194, HW37195, HW37196, HW37199, HW37200, HW37210, HW37212, HW37213, HW37214, HW37215, HW37216, HW37218, HW37222, HW37223, HW37225, HW37226, HW37228, HW37230, HW37231, HW37232, HW37233, HW37234, HW37241, HW37242, HW37243, HW37245, HW37246, HW37273, HW37276, HW37350, HW37362, HW37365, HW37366, HW37367, HW37369; 1103: GTIN 00888707002639: Serial Numbers: HW28807R01, HW28965, HW29296, HW29337R01, HW29448, HW29498R01, HW29530, HW29642R01, HW29738, HW29744, HW29865R02, HW29905R01, HW29906, HW29969, HW30008, HW30122, HW30174, HW30233, HW30235, HW30268R01, HW30269R01, HW30312, HW30441, HW30630, HW30673, HW30925, HW31182, HW31259, HW31324, HW31336, HW30685, HW30757, HW31127, hw31193, HW31463, HW29890, HW30760, HW30773, HW30010, HW30565, HW30755, HW31191, HW31298, hw31024, HW30023R01, HW30070, HW30071, HW30295, HW30315, HW30629, HW30747, HW31404, HW30620, HW29632, HW29907, HW30050, HW30064, HW30132, HW30220, HW30250, HW30259R01, HW30492, HW30617, HW30745, hw30947, hw31078, HW31462, HW28956, HW29301, HW29499R01, HW29984R02, HW30442, HW31459, HW31460, HW30677, HW30703, hw31013, HW31038, HW31053, HW31004, HW31046, HW31060, HW31149, hw31217, HW31010, HW30581, HW30605, HW30613, HW30628, HW30884, HW30439, HW31065, HW31321, HW29720R01, HW30007, HW30009R01, HW30474, HW30493, HW30458, HW30611, HW29326R01, HW29334R01, hw29828R01, HW30724, HW30750, HW31623, HW34506, HW34654, HW34798, HW31407, HW31537, HW31765, HW31914, HW32339, HW32424, HW34127, HW34298, HW34299, HW34865, HW34874, HW29910R01, HW30177, HW30337, HW30349R01, HW30541, HW30557, HW30751, hw30936, HW31220, HW31575, HW31591, HW31649, HW29739, HW29777, HW29889, HW30059, HW30061, HW30077, HW32485, HW32545, HW34831, HW34832, HW29626, HW29960, HW30129, HW30159, HW30302, HW30457, HW31730, HW32003, HW32451, HW34162, HW34634, HW34679, HW34736, HW34984, HW35152, HW35299, HW29710, HW29730, HW29732, HW29733, HW29813, HW29855R01, HW30065, HW30246, HW30265R01, HW30334, HW30340, HW30377, HW30424, HW30426, HW30440, HW30551, HW30681, HW30772, HW30789, HW30911, hw30942, hw30943, HW30977, HW30997, HW31002, HW31029, hw31057, HW31198, HW31213, hw31224, HW34137, HW32005, HW32267, HW34741, HW30238, HW30631, HW30649, HW30782, HW30786, hw31292, HW31326, HW31099, HW31177, HW31504, HW31738, HW32045, HW32418, HW34572, HW34790, HW35434, HW30063, HW30317, HW30344, HW30723, HW30779, HW31272, HW31401, HW31609, HW31613, HW32327, HW34486, HW35014, HW32019, HW34635, HW29640R01, HW29938, HW30004, HW30011, HW30076, HW30173, HW30175, HW30622, HW30759, HW30780, HW30907, HW30908, HW30921, hw31011, HW31050, HW31325, HW31368, HW31363, HW31595, HW31636, HW31638, HW31671, HW31681, HW31690, HW31962, HW31963, HW31975, HW32037, HW32069, HW32111, HW32352, HW32359, HW32380, HW32398, HW32438, HW32439, HW34135, HW34394, HW34396, HW34397, HW34671, HW34709, HW34917, HW34937, HW35110, HW35111, HW35166, HW35168, HW35431, HW35449, HW31720, HW34074, HW34323, HW34451, HW34657, HW34662, HW29962R02, HW30665, HW30701, HW30712, HW31043, HW31064, HW31241, HW31344, HW32284, HW34242, HW34264, HW34602, HW30051, HW30066, HW30887, HW31890, HW32176, HW32361, HW34189, HW34714, HW30553, HW30727, HW31862, HW34952, HW30183, HW30191, HW30882, HW30893, HW31061, HW34167, HW34532, HW30781, HW31776, HW34194, HW34763, HW35058, HW30330, HW32405, HW34416, HW34585, HW34872, HW35015, HW35081, HW35422, HW29528, HW29807, HW29860, HW29902, HW29933, HW29953, HW29977R02, HW29987R02, HW29998, HW30281, HW30318, HW30403, HW30554, HW30555, HW30567, HW30583, HW30627, HW30897, hw31102, HW31476, HW31484, HW29623, HW30248, HW30573, HW30700, HW35003, hw30932, HW31122, HW31131, HW34525, HW34676, HW34931, HW31648, HW32145, HW32409, HW34854, HW35257, HW30636, HW30640, HW30641, HW30918, hw30941, hw31073R01, HW31142, HW31186, HW31214, hw31000, HW31643, HW31747, HW32130, HW35008, HW29919R01, HW30582, HW30886, HW31126, HW31479, HW32117, HW30610, HW31719, HW32425, HW32469, HW32498, HW34505, HW35450, HW29823R02, HW30241, HW30257, HW30258, HW30427, HW30460, HW30898, HW30975, HW34386, HW34793, HW29891, HW30448, HW30587, HW30687, HW31159, HW31203, HW31478, HW34699, HW35069, HW29792, HW29804, HW29814, HW29816, HW29948, hw30929, hw31237, HW31256, HW31490, HW31189, HW34067, HW34230, HW35193, HW29805, HW29930, HW30261R01, HW30282, HW30285, HW30571, HW30586, HW30758, HW30787, HW30788, HW30790, HW31339, HW31349, HW31361, HW31389, HW34263, HW34265, HW34314, HW34483, HW34777, HW35176, HW35183, hw29709R01, HW29742, HW29929, HW29939, HW30171, HW30270R01, HW30339, HW30350, HW30696, hw30990, hw31059, HW31184, HW31215, HW34055, HW34155, HW34156, HW34978, hw29643R01, HW30013, HW30014, HW30616, HW31152, HW31529, HW31540, HW31359, HW31570, HW31951, HW34188, HW35026, HW35107, HW29897, HW29925, HW30180, HW30181, HW30243, HW30274R01, HW30294, HW30298, HW31783, HW32456, HW34118, HW30578, hw31008, HW31047, HW31678, HW30128, HW30131, HW30185, HW30417, HW30418, HW30563, HW30883, HW30889, HW31888, HW32395, HW34469, HW30015, HW31174, HW31181, HW31265, HW31869, HW34645, HW34970, HW35452, HW31480, HW31599, HW32375, HW29636, HW30311, HW30531, HW30756, HW31330, HW35206, HW29638, HW29663, HW29678, HW29751, HW29778, HW29829R02, HW30056R01, HW30062, HW30127, HW30203, HW30206, HW30273, HW30332, HW30356, HW30357, HW30450, HW30754, HW30891, hw30945, hw31005, HW31135, HW29874, HW31608, HW31797, HW34064, HW34689, HW29766, HW31942, HW34282, HW34492, HW34653, HW35415, HW29818, HW29819, HW29862, HW29899R01, HW30215, HW30244, HW30280R01, HW30283, HW30303, HW30327, HW30336, HW30416, HW30527, HW30576, HW30625, HW30626, HW30693, HW30704, HW30713, HW30721, HW30730, HW30742, HW30749, HW30775, HW30903, HW30906, HW30909, HW30922, hw30935, hw30994, hw30995, HW31030, hw31031, HW31034, HW31069, HW31209, HW31212, HW31327, HW31465, HW31466, HW34315, HW34715, HW35180, HW35182, HW35264, HW29857, HW30672, HW31289, HW32271, HW32280, HW34016, HW34566, HW35115, HW28961R01, HW29338R01, HW29398R01, HW29443, HW29848R01, HW29863R01, HW30694, HW30715, HW30762, hw31210, hw31274, HW31280, HW31313, HW32283, HW34300, HW34306, HW34353, HW34976, HW30033R02, HW30310, HW30313, HW30679, HW30684, HW30900, HW30905, hw30938, hw30992, HW31320, HW29941R01, HW30618, HW31190, HW31502, HW32318, HW34304, HW34410, HW34441, HW34562, HW34677, HW34698, HW35089, HW35226, HW29715, HW29817, HW29878, HW29892, HW29934, HW29935R01, HW29973, HW30000, HW30016, HW30017R01, HW30019, HW30048, HW30068, HW30188, HW30189, HW30266R01, HW30561, HW30585, HW30697, HW31331, HW31461, HW31391, HW32020, HW32178, HW32533, HW34702, HW34781, HW35167, HW30228, HW30247, HW30287, HW30326, HW30686, HW30689, hw30927, HW31227, HW31470, HW29831, HW31705, HW34823, HW35442, hw29785R01, HW30433R01, HW30612, HW31006, HW31315, HW31536, HW32105, HW34083, HW34476, HW29599, HW30025R02, HW30993, hw31022, HW32417, HW34199, HW34650, HW35010, HW35011, HW35066, HW35082, HW35241, HW35273, HW31535, HW31870, HW32184, HW32362, HW32512, HW34219, HW34221, HW34477, HW35461, HW35462, HW29824R01, HW30242, HW30436R01, HW30623, HW30888, HW31185, HW31311, HW31400, HW35106, HW29856R02, HW29861R01, HW29884, HW29912, HW30296, HW30346, HW30454, HW30729, HW35195, HW31990, HW32300, HW32334, HW32351, HW32487, HW34735, HW35242, HW29527, HW29728, HW30119, HW30163, HW30584, HW32140, HW34390, HW35169, HW29294, HW29621, HW29879, HW29885, HW29979R02, HW30021R01, HW30507, HW30544, HW30580, HW30615, HW30682, HW30691, HW30692, HW30725, HW31051, HW31329, HW31334, HW31335, HW34216, HW30041, HW34168, HW34589, HW34593, HW34684, HW35118, HW29497R01, HW29598, HW29957, HW30072, HW30073, HW30074, HW30075, HW30299, HW30300, HW30306, HW30761, HW30774, hw30940, hw30987, hw31197, HW31464, HW29531, HW29634, HW29951, HW30002, HW35072, HW30309, HW31369, HW32251, HW32376, HW34856, hw31040, HW29322, HW32082, HW32083, HW34171, HW35437.hw30999, HW31225, HW35059, HW35135, HW34081, HW35232, HW31568, HW34580, HW34787, HW34860, HW34896, HW35048, HW29625, HW29662, hw29852R01, HW29908R01, HW29924, HW30049, HW30052, HW30057, HW30097, HW30124, HW30133, HW30179, HW30251, HW30264R01, HW30429, HW30432, HW30489, HW30566, HW30678, HW30690, HW30753, hw30926, HW30969, hw31027, HW31231, hw31236, HW31278, HW32107, HW34105, HW29868, HW29950, HW30176, HW30182, HW30260R01, HW30428, HW30530, HW30688, HW31054, HW31528, HW31611, HW31709, HW32382, HW34158, HW34322, HW29944, HW30012, HW30271R01, HW30305, HW30447, HW30577, HW30657, hw30931, hw31204, HW31221, HW31469, HW29809, HW31281, HW31634, HW31689, HW34218, HW34770, HW35436, HW35456, HW29624, HW30291, HW30464, HW30487, HW30637, HW30899, HW31007, hw31012, HW31397, HW31576, HW31764, HW32087, HW32151, HW32428, HW34413, HW34504, HW34814, HW35126, HW35243, HW35471, HW35473, HW29812, HW29854, HW30005, HW30067, HW30425, HW30465, HW30718, HW30719, HW30744, HW30902, HW30914, HW31116, hw31200, HW31201, HW31474, HW31646, HW31695, HW31785, HW32312, HW32381, HW34160, HW34258, HW34479, HW34811, HW34999, HW35116, HW29773, HW29822, HW30276R01, HW30307, HW30351, HW30420, HW30437, HW30452, HW30470, HW30481, HW30488, HW30495, HW30496, HW30534, HW30545, HW30550, HW30709, HW30777, HW31042, hw31056, HW31066, HW31067, HW31068, HW31316, HW31946, HW35249, HW35255, hw29611R01, HW30304, HW30321, HW30343, HW30466, HW30479, HW30533, HW30540, HW30570, HW30572, HW31206, HW31612, HW31624, HW31652, HW31653, HW32463, HW34233, HW34389, HW35469, HW29806, HW30190, HW30192, HW30316, HW30331R01, HW30341, HW30438, HW30459, HW30536, HW30895, hw31019, hw31222, HW31542, HW31923, HW32449, HW34153, HW34534, HW34599, HW29716, HW29858R02, HW30444, HW30476, HW30647, HW30683, HW30695, HW30752, HW30892, hw31028, hw31044, HW31396, HW31567, HW34485, HW29838R01, HW29888, HW30006, HW30184, hw31023, HW31617, HW31829, HW31880, HW32074, HW32399, HW35280, HW29637, hw29647R01, HW29913R01, HW29942, HW29952, HW30290, HW30419, HW30535, HW30579, HW30648, HW30676, HW30717, HW31477, HW31347, HW30234, HW30680, HW30890, hw30991, hw30998, HW31055, HW31866, HW32262, HW32431, HW34453, HW34577, HW34578, HW35288, HW35433, HW31606, HW31716, HW32044, HW32063, HW34183, HW34240, HW34473, HW31337, HW31345, HW32323, HW32325, HW29628, HW31139, HW32422, HW30245, HW31762, HW31971, HW29745, HW30055, HW30221R01, HW30286R01, HW30288R01, HW30519, HW30568, HW30569, HW30588, HW30910, HW30920, HW30924, hw31025R01, HW31172, HW31270, HW31395, HW31405, HW32491, HW34164, HW34658, HW30130, HW30256, HW30434, HW31188, HW31312, HW31467, HW31468, HW31498, HW30379, HW30574, HW29920R01, HW31153, HW31807, HW32146, HW32370, HW34174, HW34499, HW34683, HW34825, HW29703R02, HW29881, HW30272R01, HW30348, HW30546, HW30710, HW30785, HW31041, HW31240, HW31245, HW34690, HW30698, HW30699, HW31160, HW31169, HW31782, HW31798, HW31864, HW32402, HW34496, HW34921, HW35159, HW35263, HW35287, HW29772, HW30001, HW30162, HW30720, HW30732, HW30912, HW31230, HW31302, HW31897, HW32089, HW30669, HW30708, HW31001, HW31062, HW31318, HW31481, HW32486, HW34858, HW29740, HW29808, HW29871, HW30236, HW30674, HW30901, HW31279, HW34080, HW32500, HW34391, HW34466, HW34467, HW34601, HW34775, HW35219, HW35238, HW35403, HW35413, HW29713R03, HW30731, HW31308R01, HW34463, HW30078, HW32379, HW34312, HW34406, HW34883, HW35427, HW35448, HW29221, HW29336R01, HW29340R01, HW29450, HW29452, HW29501R01, HW29619, HW29966, HW30134, HW30329, HW30532, HW30575, HW30621, HW30624, HW30707, HW30748, hw31052R01, HW31118, HW31246, HW30240R01, HW30279R01, HW30539, HW31300, HW31871, HW32110, HW35425, HW29811R01, HW31562, HW31775, HW31800, HW32188, HW32276, HW32535, HW32550, HW34163, HW34195, HW34465, HW34815, HW35260, HW29945, HW30161, HW30187, HW30232, HW30338, hw30930, HW31269, HW32332, HW34407, HW34537, HW34826, HW30904, HW31626, HW32136, HW32390, HW34116, HW34143, HW35222, HW31199, HW35181, HW30642, HW31356, HW29622, HW29726, hw29851R01, HW30262R01, HW30284R01, HW30314, HW30335, HW30778, HW30792, HW30913, HW30965, hw30989, HW31239, HW31692, HW31898, HW32126, HW32249, HW32363, HW32442, HW34646, HW34788, HW34795, HW35029, HW35045, HW35047, HW35235, HW35236, HW35438, HW35447, HW29163, HW30388, HW30422, HW30431, HW30446, HW30478, HW30482, HW30490, HW30543, HW30548, HW30644, HW30714, HW30716, hw30944, HW31205, hw31229, HW31238, HW31243, HW32346, HW32527, HW32532, HW35020, HW35130, HW35294, HW35295, HW31151, HW34212, HW34956, HW29445, HW29529, HW30164, HW31218, HW31306, HW35051, HW35440, HW28725R01, HW30443, HW30702, HW30923, hw31033, HW31039, HW31900, HW34175, HW34228, HW34311, HW34399, HW34660, HW29194, HW29849, HW30020R01, HW30123, HW30186, HW30292, HW30293, HW30564, HW31392, HW34574, HW34575, HW34576, HW34967, HW35293, HW29631, HW29753, HW30237, HW30249, HW30537, HW30562, hw30937, hw30946, HW31501, HW29914R01, HW30125, HW30435, HW30542, HW31615, HW32540, HW34289, HW34548, HW34549, HW35129, hw29613R01, HW29981R02, HW30277R01, HW30301, HW30538, HW30559, HW30746, HW30917, hw31195, HW35454, HW29630, HW31045, hw31211, HW34728, HW34729, HW29719, HW30054, HW30126, HW30308, HW30560, HW30885, HW30896, HW31304, HW31482, HW30169, HW31367, HW29743, HW31740, HW31741, HW31918, HW34014, HW34333, HW34472, HW34545, HW34608, HW34721, HW34828, HW34987, HW35098, hw29706R01, HW29735, HW30172, HW30333, HW30451, HW30668, HW30722, HW30784, HW30915, hw30928, HW31049, HW32345, HW35424, HW31674, HW31677, HW32480, HW34321, HW34611, HW34613, HW35077, HW35190, HW35192, HW35221, HW29799R01, HW29810R01, HW30053, HW30069, HW30217, HW30230, HW30278R01, HW30347, HW30456, HW30675, HW30894, HW31017, HW31323, HW31475, HW32119, HW32313, HW34471, HW34648, HW35076, HW30160, HW30165, HW30218, HW30219, HW30323, HW30328, HW30552, HW30592, HW30659, HW30671, HW31207, HW31333, HW29946, HW31804, HW30480, HW30547, HW30653, HW34245, HW29610R01, HW30216, HW30289R01, hw31109, HW29627, HW29872R02, HW29937, HW30058, HW30060, HW30120, HW30168, HW30263, HW30325, HW30423, HW30556, HW30558, HW30609, HW30670, HW31148, HW31522, HW31647, HW34119, HW34166, HW29335R01, HW29803, hw30933, HW31097, HW31403; GTIN 00888707003261: Serial Numbers: HW40229, HW40405, HW40436, HW40567, HW40568, HW41753, HW40261, HW40601, HW40717, HW40764, HW40880, HW41248, HW41446, HW41692, HW41296, HW40977, HW41061, HW41478, HW41488, HW40145, HW40209, HW40264, HW40299, HW40301, HW40381, HW40389, HW40455, HW40524, HW40527, HW40620, HW40640, HW40643, HW40734, HW40737, HW40738, HW40762, HW40834, HW40288, HW40326, HW41752, HW40222, HW40223, HW40443, HW40922, HW40504, HW40575, HW40576, HW40822, HW41100, HW41118, HW40569, HW40694, HW41823, HW40147, HW40635, HW41476, HW41584, HW41586, HW41588, HW41797, HW41761, HW42169, HW40154, HW40086, HW40139, HW40140, HW40169, HW40176, HW40206, HW40208, HW40226, HW40272, HW40306, HW40323, HW40324, HW40331, HW40340, HW40361, HW40364, HW40466, HW40490, HW40491, HW40492, HW40497, HW40518, HW40590, HW40591, HW40592, HW40593, HW40617, HW40622, HW40718, HW40719, HW40744, HW40813, HW40821, HW40826, HW40827, HW40829, HW40830, HW40831, HW40868, HW41157, HW41158, HW41159, HW41160, HW41162, HW41165, HW41166, HW41167, HW41410, HW41412, HW41414, HW41417, HW41419, HW41420, HW41423, HW41735, HW41748, HW41749, HW41819, HW41820, HW41836, HW41837, HW41867, HW42129, HW42134, HW42254, HW42277, HW42319, HW42320, HW42323, HW42389, HW42768, HW42809, HW42810, HW42819, HW40778, HW42164, HW40488, HW41830, HW42201, HW40074, HW40075, HW40037, HW40199, HW40453, HW41141, HW41490, HW41856, HW40245, HW40440, HW40627, HW40772, HW40798, HW40884, HW40903, HW40907, HW40985, HW41038, HW41067, HW41444, HW41445, HW41884, HW42222, HW42802, HW42804, HW40503, HW41733, HW40051, HW40068, HW40230, HW40517, HW40572, HW40703, HW40749, HW40781, HW40815, HW40891, HW40908, HW40996, HW41032, HW41288, HW41318, HW41457, HW41503, HW41504, HW41636, HW41678, HW41707, HW41708, HW41729, HW41799, HW41841, HW41861, HW42824, HW41629, HW41774, HW40433, HW40595, HW40986, HW40991, HW41006, HW41054, HW41093, HW41154, HW41393, HW41398, HW42315, HW42807, HW40515, HW40585, HW41069, HW41529, HW41598, HW41642, HW41649, HW40238, HW40293, HW40337, HW40384, HW41091, HW41889, HW42173, HW42384, HW40510, HW40918, HW41883, HW40995, HW41107, HW41844, HW42628, HW40197, HW40382, HW40397, HW40894, HW40988, HW41137, HW41451, HW41659, HW41711, HW41805, HW41838, HW42317, HW42343, HW42631, HW42730, HW40460, HW41077, HW41530, HW41689, HW41690, HW40067, HW40079, HW40916, HW41361, HW40451, HW40962, HW40710, HW40805, HW41404, HW41713, HW42172, HW42745, HW40715, HW40776, HW40939, HW41005, HW41456, HW41877, HW42336, HW42820, HW40948, HW41510, HW41524, HW41807, HW42805, HW40009, HW40232, HW40271, HW41858, HW40292, HW40976, HW40987, HW41515, HW40090, HW40270, HW40862, HW41605, HW41354, HW40065, HW40073, HW40528, HW40800, HW40801, HW41148, HW41238, HW41378, HW41387, HW41388, HW41389, HW41541, HW41691, HW41702, HW41821, HW40149, HW40501, HW40633, HW40723, HW40913, HW41242, HW41480, HW41617, HW41618, HW42208, HW40204, HW40520, HW41732, HW42627, HW40201, HW40399, HW40404, HW40708, HW40924, HW40965, HW41146, HW41492, HW41664, HW40033, HW40281, HW40359, HW40606, HW40838, HW41008, HW41185, HW41194, HW41247, HW41280, HW41283, HW41310, HW41411, HW41550, HW40120, HW40143, HW40191, HW40305, HW41865, HW42257, HW40085, HW40168, HW40317, HW40794, HW40883, HW41073, HW41176, HW41179, HW41180, HW42121, HW40807, HW41057, HW41213, HW41507, HW41626, HW40769, HW41234, HW41499, HW42239, HW40265, HW40283, HW41516, HW42346, HW41888, HW42170, HW40036, HW40045, HW40048, HW40177, HW40259, HW40263, HW40644, HW40646, HW40647, HW40750, HW40819, HW41012, HW41138, HW41139, HW41225, HW41298, HW41441, HW41443, HW41517, HW41526, HW41606, HW41669, HW41789, HW41873, HW42125, HW40682, HW40481, HW41634, HW41668, HW41817, HW40109, HW40179, HW40190, HW40214, HW40240, HW40448, HW40902, HW41084, HW41496, HW41549, HW41573, HW40049, HW40097, HW40705, HW40739, HW40925, HW40944, HW41022, HW41072, HW41076, HW41098, HW41131, HW41132, HW41232, HW41237, HW41274, HW41369, HW41394, HW41396, HW41418, HW41424, HW41425, HW41427, HW41428, HW41431, HW41432, HW41435, HW41438, HW42242, HW42281, HW42284, HW42318, HW42734, HW40099, HW41001, HW41483, HW41509, HW41514, HW41521, HW41525, HW41591, HW41635, HW41747, HW41834, HW40142, HW40166, HW40260, HW40279, HW40391, HW40529, HW40803, HW41007, HW41037, HW41102, HW41195, HW41336, HW41650, HW41651, HW41703, HW41730, HW42732, HW40258, HW40314, HW40523, HW40698, HW40861, HW40967, HW40971, HW41017, HW41060, HW41403, HW41421, HW41585, HW41680, HW40992, HW41042, HW41104, HW41105, HW41846, HW42383, HW41391, HW40244, HW40892, HW40897, HW41555, HW41666, HW41715, HW41788, HW41809, HW41485, HW41815, HW40273, HW40757, HW42762, HW41647, HW40334, HW40322, HW40392, HW41558, HW41746, HW41409, HW41613, HW41766, HW40402, HW40700, HW41547, HW41688, HW42993, HW40138, HW40714, HW40157, HW40483, HW40605, HW40683, HW40759, HW41097, HW41564, HW41768, HW41779, HW41868, HW40905, HW41364, HW41543, HW40121, HW40178, HW41212, HW41439, HW40444, HW41551, HW41633, HW41644, HW40171, HW40200, HW40210, HW41223, HW42207, HW40753, HW40930, HW41182, HW41497, HW41563, HW41622, HW41842, HW42136, HW42220, HW42338, HW41018, HW41172, HW41224, HW41538, HW41556, HW42626, HW40152, HW40153, HW40212, HW40256, HW40262, HW41348, HW41578, HW41662, HW41724, HW40291, HW40403, HW40512, HW40530, HW40546, HW40695, HW41351, HW40006, HW41440, HW41453, HW41575, HW40094, HW40159, HW40684, HW41092, HW41278, HW41285, HW41326, HW41337, HW41773, HW41810, HW41811, HW41813, HW41814, HW41862, HW41882, HW40013, HW40329, HW40687, HW40768, HW40808, HW40935, HW41035, HW41066, HW41227, HW41228, HW41229, HW41250, HW41275, HW41289, HW41461, HW41603, HW41812, HW42772, HW40017, HW40672, HW40863, HW40865, HW41381, HW41382, HW41385, HW41630, HW41631, HW41833, HW41876, HW42382, HW41287, HW41552, HW41787, HW41866, HW41124, HW41757, HW41839, HW41569, HW41772, HW42976, HW40563, HW40882, HW41081, HW41331, HW41481, HW41489, HW40874, HW41590, HW41880, HW42124, HW41533.HW40298, HW40942, HW41408, HW41685, HW40061, HW40696, HW40722, HW41321, HW41611, HW41681, HW41786, HW41887, HW41236, HW41339, HW41341, HW41648, HW40046, HW40089, HW40100, HW40122, HW40186, HW40307, HW40390, HW40509, HW40732, HW40832, HW40968, HW41300, HW41493, HW41571, HW41574, HW40499, HW40690, HW41656, HW40777, HW41682, HW41782, HW40181, HW40247, HW40371, HW40745, HW40783, HW40998, HW41025, HW41520, HW41795, HW40841, HW40054, HW41845, HW42127, HW40689, HW41188, HW40482, HW40636, HW40678, HW40870, HW40360, HW40534, HW40537, HW40766, HW40767, HW40941, HW41059, HW41064, HW41594, HW41596, HW41719, HW42260, HW42765, HW42815, HW42994, HW42995, HW40112, HW40192, HW40294, HW40631, HW40755, HW40373, HW40583, HW40857, HW40997, HW41173, HW41174, HW41207, HW41208, HW41240, HW41295, HW41299, HW41345, HW41400, HW41459, HW41460, HW41462, HW41463, HW41464, HW41465, HW41467, HW41468, HW41470, HW41519, HW41522, HW41531, HW41548, HW41577, HW41608, HW41612, HW41614, HW41616, HW41627, HW41679, HW41712, HW42139, HW42142, HW42144, HW42146, HW42147, HW42210, HW42378, HW42736, HW42739, HW40004, HW41607, HW41646, HW41770, HW41800, HW40202, HW40746, HW41058, HW41479, HW41486, HW41818, HW40489, HW41330, HW42727, HW42731, HW41731, HW41885, HW42728, HW40876, HW40025, HW40211, HW40437, HW41024, HW41322, HW41327, HW41355, HW41494, HW41034, HW41560, HW41386, HW42218, HW41475, HW40002, HW40108, HW40130, HW40189, HW40198, HW40441, HW40558, HW40780, HW40809, HW40810, HW40887, HW40917, HW41111, HW41112, HW41115, HW41484, HW41657, HW41822, HW41860, HW42283, HW42324, HW41186, HW40445, HW40533, HW40597, HW40616, HW40621, HW40927, HW40928, HW41090, HW40376, HW40875, HW40994, HW41002, HW41144, HW41360, HW41508, HW41511, HW41589, HW41686, HW40302, HW40303, HW40087, HW41319, HW41334, HW41537, HW41721, HW41756, HW42279, HW42494, HW40295, HW42385, HW42387, HW40728, HW41276, HW41338, HW40255, HW41734, HW41291, HW40395, HW41687, HW41751, HW41528, HW41604; 1104JP: GTIN 00763000170967, Serial Numbers: HW40657, HW40658, HW40659, HW40660, HW40662, HW40663, HW40664, HW40665, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40952, HW40953, HW40954, HW40955, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045, HW41047, HW41048, HW41050, HW41214, HW41251, HW41252, HW41254, HW41255, HW41256, HW41258, HW41259, HW41260, HW41262, HW41263, HW41264, HW41265, HW41266, HW41269, HW41270, HW41271, HW41308, HW41309, HW41314, HW41316, HW41317, HW41670, HW41672, HW41673, HW41674, HW41675, HW41694, HW41698, HW41699, HW41700, HW41701, HW41783, HW41791, HW41792, HW41803, HW41804, HW41824, HW41826, HW41828, HW41847, HW41848, HW42285, HW42312, HW42352, HW42771, HW42884; GTIN 00888707005838, Serial Numbers: HW42818, HW41784, HW41825, HW41827, HW41829, HW41849, HW41850, HW41852, HW41853, HW41863, HW42882; MCS1705PU: GTIN 00888707005364, Serial Numbers: HW42371, HW42374, HW43227, HW43329, HW43330, HW43334, HW43335, HW42071, HW42296, HW42380, HW42270, HW42272, HW43217, HW43219, HW43220, HW43324, HW43325, HW42267, HW43107, HW43109, HW43115, HW43116, HW43117, HW43188, HW43319, HW43363, HW43364, HW43185, HW43197, HW43275, HW43320, HW43047, HW43048, HW43306, HW43318, HW42418, HW42610, HW42611, HW43040, HW43041, HW43042, HW43258, HW43270, HW43322, HW43352, HW43357, HW43223, HW43226, HW42579, HW42580, HW43123, HW42400, HW42574, HW42576, HW43313, HW43358, HW42448, HW42571, HW43049, HW43050, HW42423, HW42424, HW42205, HW42301, HW42402, HW43051, HW43236, HW42068, HW42069, HW42086, HW42087, HW42174, HW42180, HW42181, HW42182, HW42184, HW42191, HW42192, HW43261, HW42202, HW42375, HW42379, HW43112, HW43316, HW42264, HW42266, HW42362, HW42363, HW42195, HW42420, HW42422, HW41765, HW42070, HW42364, HW42499, HW42578, HW42593, HW43230, HW43037, HW43038, HW43039, HW43052, HW43247, HW43257, HW43279, HW43356, HW42268, HW42577, HW42582, HW43079, HW43125, HW43244, HW43276, HW43307, HW43308, HW43312, HW43098, HW43120, HW43190, HW43191, HW43192, HW42176, HW42179, HW42297, HW42298, HW43129, HW43157, HW43175, HW43336, HW43338, HW42599, HW42600, HW42601, HW42083, HW42084, HW43044, HW43278, HW43354, HW42425, HW42431, HW43090, HW43101, HW43103, HW43187, HW43222, HW42078, HW42081, HW42082, HW42302, HW42366, HW42367, HW42368, HW43351, HW43373, HW43053, HW43145, HW43183, HW42248, HW42261, HW42584, HW42591, HW43176, HW43221, HW43240, HW42359, HW42360, HW42361, HW43194, HW43195, HW43239, HW43262, HW43268, HW42401, HW42403, HW42404, HW42405, HW42438, HW42439, HW42585, HW42586, HW42592, HW43036, HW43043, HW43054, HW43114, HW43232, HW43248, HW43249, HW43251, HW43253, HW43255, HW43361, HW43362, HW43365, HW43366, HW43371, HW43372, HW42397, HW42572, HW42573, HW42581, HW43062, HW43064, HW43282, HW43315, HW43057, HW43059, HW43060, HW43061, HW42595, HW42596, HW43045, HW43046, HW42588, HW42590, HW43178; GTIN 00888707007139, Serial Numbers: HW42372, HW42691, HW42692, HW42693, HW42694, HW42695, HW42696, HW42697, HW42699, HW42701, HW42704, HW42705, HW42706, HW42713, HW42826, HW42832, HW42839, HW42845, HW42846, HW42847, HW42853, HW42924, HW42925, HW42929, HW42930, HW42934, HW42935, HW42936, HW42945, HW42946, HW42950, HW42951, HW42954, HW42956, HW42957, HW42958, HW42959, HW42962, HW42963, HW42972, HW42975, HW42977, HW42978, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW43015, HW43019, HW43027, HW42955, HW43020; GTIN 00888707007160, Serial Number: HW43453; IFU, ERG, and PM catalogue numbers affected: GR00526: GTIN none, Serial Numbers: R021023, R021429, R022801, R023432, R024437, R021282, r023861, R022197, R022370, R024915, R025043, R025705, R023396, R024765, R027316; IFU00358: GTIN none, Serial Numbers: R020473, R020606, R020606, R020606, R021125, R021136, R021369, R024757; IFU00375: GTIN none, Serial Numbers: R021019, R025232, R027762, R028481, R021165, R024178, R024545, R024582, R022376, R024865, R023318, R022436, R027594, R026582, R026753, R027045, R028937, R021663, R026907, R028908; IFU00376: GTIN none, Serial Numbers: R021020, R021167, R022413, R022970, R023478, R024524, R024976, R025507, R029513, R024548, R026621, R027923, R022093, R022284, R021121, R024142, R024200, R021567, R028415, R023279, R023435, R026473, R027670, R028603, R027058, R025102, R024867, R027403, R026271, R026904, R028939, R029066; IFU00520: GTIN none, Serial Numbers: R025351, R026900; IFU00526: GTIN none, Serial Number: R025761R01; IFU00593: GTIN none, Serial Number: R027857; IFU00614: GTIN none, Serial Number: R028505; M017475C001: GTIN none, Serial Number: R029651;
Recalling Firm/
Medtronic Inc
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
For Additional Information Contact MCS Customer Service
Manufacturer Reason
for Recall
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
FDA Determined
Cause 2
Labeling design
Action Starting 30-Mar-2022, Medtronic issued an Urgent Medical Device Notice by letter to VAD Coordinators at customer sites in order to inform them of the errors and the corrections impacting the Instructions for Use, Patient Manual, and Emergency Responder Guide for the HVAD System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual. Customer Instructions: "Please ensure your patients on support are aware of the changes to the PM. "Please share this notice with everyone in your organization who needs to be aware. "Continue to monitor patients per your practice's standard follow-up procedures. "Please complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. For questions regarding this material, customers should contact their Medtronic Field Representative, MCS Customer Service or (877) 367-4823. .
Quantity in Commerce 21,118 pieces of product literature
Distribution Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic