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U.S. Department of Health and Human Services

Class 1 Device Recall HVAD Pump Implant Kit

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  Class 1 Device Recall HVAD Pump Implant Kit see related information
Date Initiated by Firm April 03, 2020
Create Date May 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-2055-2020
Recall Event ID 85397
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Code Information GTIN 00888707000017, Serial Numbers: HW26899, HW27283, HW27893, HW28873, HW28999, HW29422, HW29488, HW29722, HW30166, HW30170  GTIN 00888707002639, Serial Numbers: HW29525, HW30015, HW30297, HW30477, HW31174, HW31179, HW31181, HW31246, HW31247, HW31250, HW31253, HW31257, HW31266, HW31268, hw31280, HW31281, hw31282, HW31283, HW31313, HW31385, HW31401, HW31497, HW31525, HW31526, HW31530, HW31531, HW31562, HW31567, HW31596, HW31597, HW31601, HW31602, HW31608, HW31609, HW31612, HW31624, HW31626, HW31634, HW31640, HW31641, HW31642, HW31643, HW31644, HW31645, HW31646, HW31647, HW31648, HW31649, HW31651, HW31652, HW31653, HW31655, HW31656, HW31657, HW31658, HW31659, HW31660, HW31661, HW31662, HW31663, HW31665, HW31666, HW31667, HW31668, HW31669, HW31670, HW31671, HW31672, HW31674, HW31675, HW31676, HW31677, HW31678, HW31679, HW31680, HW31681, HW31682, HW31687, HW31688, HW31689, HW31690, HW31691, HW31692, HW31693, HW31695, HW31696, HW31701, HW31705, HW31706, HW31707, HW31708, HW31709, HW31710, HW31711, HW31712, HW31713, HW31714, HW31716, HW31717, HW31719, HW31720, HW31721, HW31722, HW31723, HW31724, HW31725, HW31726, HW31728, HW31730, HW31732, HW31734, HW31736, HW31737, HW31738, HW31739, HW31740, HW31741, HW31742, HW31743, HW31744, HW31745, HW31746, HW31747, HW31748, HW31751, HW31752, HW31753, HW31754, HW31756, HW31757, HW31758, HW31760, HW31761, HW31762, HW31763, HW31764, HW31765, HW31766, HW31767, HW31768, HW31769, HW31770, HW31771, HW31772, HW31773, HW31774, HW31775, HW31776, HW31781, HW31782, HW31783, HW31784, HW31785, HW31786, HW31787, HW31788, HW31789, HW31790, HW31792, HW31793, HW31794, HW31796, HW31797, HW31798, HW31799, HW31800, HW31802, HW31803, HW31804, HW31805, HW31807, HW31816, HW31829, HW31841, HW31848, HW31850, HW31853, HW31854, HW31857, HW31861, HW31862, HW31864, HW31865, HW31866, HW31867, HW31868, HW31869, HW31870, HW31871, HW31878, HW31879, HW31880, HW31881, HW31882, HW31884, HW31885, HW31886, HW31887, HW31888, HW31889, HW31890, HW31894, HW31895, HW31896, HW31897, HW31898, HW31899, HW31900, HW31902, HW31904, HW31905, HW31906, HW31907, HW31910, HW31911, HW31913, HW31914, HW31916, HW31917, HW31918, HW31922, HW31923, HW31933, HW31935, HW31936, HW31938, HW31942, HW31943, HW31945, HW31946, HW31948, HW31949, HW31950, HW31951, HW31952, HW31953, HW31954, HW31956, HW31957, HW31959, HW31960, HW31961, HW31962, HW31963, HW31964, HW31965, HW31966, HW31967, HW31968, HW31969, HW31970, HW31971, HW31972, HW31974, HW31975, HW31977, HW31978, HW31980, HW31990, HW32003, HW32004, HW32005, HW32007, HW32016, HW32019, HW32020, HW32031, HW32033, HW32037, HW32041, HW32044, HW32045, HW32047, HW32048, HW32049, HW32051, HW32052, HW32054, HW32058, HW32059, HW32060, HW32061, HW32063, HW32066, HW32067, HW32069, HW32070, HW32072, HW32073, HW32074, HW32075, HW32076, HW32077, HW32078, HW32079, HW32080, HW32082, HW32083, HW32084, HW32087, HW32088, HW32089, HW32090, HW32091, HW32092, HW32093, HW32095, HW32096, HW32097, HW32098, HW32099, HW32100, HW32101, HW32104, HW32105, HW32106, HW32107, HW32110, HW32111, HW32114, HW32115, HW32117, HW32119, HW32120, HW32122, HW32126, HW32127, HW32128, HW32129, HW32130, HW32133, HW32134, HW32136, HW32137, HW32139, HW32140, HW32142, HW32145, HW32146, HW32148, HW32150, HW32151, HW32154, HW32155, HW32157, HW32158, HW32168, HW32169, HW32171, HW32173, HW32174, HW32176, HW32177, HW32178, HW32184, HW32185, HW32187, HW32188, HW32191, HW32196, HW32203, HW32208, HW32213, HW32225, HW32227, HW32233, HW32235, HW32237, HW32247, HW32249, HW32251, HW32252, HW32254, HW32262, HW32266, HW32267, HW32271, HW32272, HW32274, HW32275, HW32276, HW32277, HW32278, HW32280, HW32283, HW32284, HW32287, HW32288, HW32291, HW32293, HW32295, HW32296, HW32298, HW32299, HW32300, HW32302, HW32303, HW32304, HW32305, HW32306, HW32307, HW32308, HW32310, HW32311, HW32312, HW32313, HW32314, HW32316, HW32317, HW32318, HW32319, HW32320, HW32321, HW32322, HW32323, HW32324, HW32325, HW32326, HW32327, HW32328, HW32329, HW32330, HW32331, HW32332, HW32333, HW32334, HW32337, HW32338, HW32339, HW32340, HW32341, HW32343, HW32344, HW32345, HW32346, HW32348, HW32349, HW32350, HW32351, HW32352, HW32354, HW32355, HW32358, HW32359, HW32360, HW32361, HW32362, HW32363, HW32364, HW32365, HW32366, HW32367, HW32368, HW32370, HW32371, HW32372, HW32374, HW32375, HW32376, HW32377, HW32378, HW32379, HW32380, HW32381, HW32382, HW32383, HW32384, HW32387, HW32389, HW32390, HW32391, HW32392, HW32395, HW32396, HW32397, HW32398, HW32399, HW32401, HW32402, HW32403, HW32404, HW32405, HW32406, HW32409, HW32411, HW32412, HW32413, HW32414, HW32417, HW32418, HW32421, HW32422, HW32424, HW32425, HW32428, HW32429, HW32430, HW32431, HW32432, HW32433, HW32434, HW32436, HW32438, HW32439, HW32440, HW32441, HW32442, HW32443, HW32444, HW32446, HW32447, HW32448, HW32449, HW32450, HW32451, HW32452, HW32453, HW32454, HW32455, HW32456, HW32460, HW32461, HW32462, HW32463, HW32466, HW32467, HW32469, HW32475, HW32476, HW32477, HW32478, HW32480, HW32481, HW32482, HW32484, HW32485, HW32486, HW32487, HW32488, HW32489, HW32490, HW32491, HW32492, HW32493, HW32494, HW32495, HW32496, HW32497, HW32498, HW32500, HW32501, HW32502, HW32503, HW32512, HW32526, HW32527, HW32528, HW32529, HW32530, HW32531, HW32532, HW32533, HW32535, HW32536, HW32537, HW32538, HW32539, HW32540, HW32541, HW32542, HW32543, HW32544, HW32545, HW32547, HW32549, HW32550, HW32551, HW32552, HW32553, HW32555, HW32556, HW34011, HW34013, HW34014, HW34016, HW34032, HW34055, HW34057, HW34058, HW34059, HW34061, HW34063, HW34064, HW34065, HW34067, HW34070, HW34071, HW34073, HW34074, HW34076, HW34077, HW34079, HW34080, HW34081, HW34082, HW34083, HW34085, HW34087, HW34089, HW34097, HW34098, HW34099, HW34101, HW34102, HW34103, HW34105, HW34108, HW34112, HW34114, HW34116, HW34118, HW34119, HW34127, HW34128, HW34130, HW34131, HW34133, HW34134, HW34135, HW34136, HW34137, HW34138, HW34139, HW34140, HW34141, HW34142, HW34143, HW34144, HW34145, HW34146, HW34147, HW34153, HW34154, HW34155, HW34156, HW34157, HW34158, HW34159, HW34160, HW34162, HW34163, HW34164, HW34165, HW34166, HW34167, HW34168, HW34170, HW34171, HW34172, HW34173, HW34174, HW34175, HW34176, HW34177, HW34178, HW34183, HW34185, HW34188, HW34189, HW34190, HW34194, HW34195, HW34198, HW34199, HW34200, HW34201, HW34203, HW34212, HW34213, HW34214, HW34215, HW34216, HW34217, HW34218, HW34219, HW34220, HW34221, HW34222, HW34223, HW34224, HW34225, HW34227, HW34228, HW34230, HW34231, HW34233, HW34234, HW34235, HW34236, HW34238, HW34239, HW34240, HW34241, HW34242, HW34243, HW34244, HW34245, HW34246, HW34247, HW34248, HW34249, HW34250, HW34253, HW34254, HW34255, HW34256, HW34257, HW34258, HW34259, HW34260, HW34261, HW34262, HW34263, HW34264, HW34265, HW34267, HW34276, HW34279, HW34282, HW34284, HW34285, HW34286, HW34287, HW34288, HW34289, HW34291, HW34294, HW34295, HW34297, HW34298, HW34299, HW34300, HW34302, HW34303, HW34304, HW34305, HW34306, HW34307, HW34308, HW34310, HW34311, HW34312, HW34313, HW34314, HW34315, HW34316, HW34318, HW34320, HW34321, HW34322, HW34323, HW34325, HW34332, HW34333, HW34334, HW34335, HW34338, HW34339, HW34353, HW34360, HW34385, HW34386, HW34387, HW34389, HW34390, HW34391, HW34392, HW34393, HW34394, HW34396, HW34397, HW34399, HW34400, HW34402, HW34403, HW34404, HW34405, HW34406, HW34407, HW34409, HW34410, HW34411, hw34413, hw34416, hw34417, HW34422, HW34423, HW34424, HW34430, HW34435, HW34441, HW34445, HW34447, HW34450, HW34451, HW34453, HW34455, HW34457, HW34458, HW34459, HW34460, HW34462, HW34463, HW34464, HW34465, HW34466, HW34467, HW34468, HW34469, HW34470, HW34471, HW34472, HW34473, HW34475, HW34476, HW34477, HW34479, HW34480, HW34481, HW34482, HW34483, HW34485, HW34486, HW34487, HW34488, HW34489, HW34492, HW34493, HW34494, HW34496, HW34498, HW34499, HW34500, HW34501, HW34502, HW34503, HW34504, HW34505, HW34506, HW34515, HW34525, HW34526, HW34527, HW34528, HW34529, HW34530, HW34531, HW34532, HW34533, HW34534, HW34535, HW34537, HW34538, HW34540, HW34541, HW34542, HW34543, HW34544, HW34545, HW34548, HW34549, HW34552, HW34553, HW34554, HW34558, HW34562, HW34564, HW34565, HW34566, HW34567, HW34568, HW34570, HW34571, HW34572, HW34573, HW34574, HW34575, HW34576, HW34577, HW34578, HW34579, HW34580, HW34581, HW34583, HW34584, HW34585, HW34587, HW34589, HW34592, HW34593, HW34597, HW34598, HW34599, HW34600, HW34601, HW34602, HW34604, HW34606, HW34608, HW34611, HW34612, HW34613, HW34614, HW34616, HW34626, HW34627, HW34632, HW34633, HW34634, HW34635, HW34638, HW34639, HW34640, HW34642, HW34644, HW34645, HW34646, HW34647, HW34648, HW34649, HW34650, HW34651, HW34652, HW34653, HW34654, HW34655, HW34657, HW34658, HW34659, HW34660, HW34661, HW34662, HW34663, HW34665, HW34667, HW34668, HW34669, HW34671, HW34672, HW34674, HW34675, HW34676, HW34677, HW34678, HW34679, HW34680, HW34681, HW34683, HW34684, HW34685, HW34686, HW34687, HW34688, HW34689, HW34690, HW34695, HW34696, HW34697, HW34698, HW34699, HW34701, HW34702, HW34705, HW34706, HW34707, HW34708, HW34709, HW34712, HW34714, HW34715, HW34716, HW34718, HW34721, HW34722, HW34725, HW34728, HW34729, HW34730, HW34731, HW34733, HW34735, HW34736, HW34740, HW34741, HW34744, HW34747, HW34754, HW34755, HW34756, HW34760, HW34763, HW34765, HW34766, HW34770, HW34771, HW34772, HW34773, HW34774, HW34775, HW34777, HW34778, HW34780, HW34781, HW34782, HW34783, HW34784, HW34786, HW34787, HW34788, HW34789, HW34790, HW34793, HW34794, HW34795, HW34796, HW34797, HW34798, HW34799, HW34800, HW34804, HW34807, HW34809, HW34811, HW34812, HW34814, HW34815, HW34816, HW34819, HW34820, HW34821, HW34822, HW34823, HW34825, HW34826, HW34827, HW34828, HW34830, HW34831, HW34832, HW34835, HW34843, HW34852, HW34854, HW34856, HW34857, HW34858, HW34859, HW34860, HW34861, HW34863, HW34865, HW34869, HW34870, HW34871, HW34872, HW34874, HW34878, HW34883, HW34887, HW34891, HW34896, HW34899, HW34917, HW34918, HW34921, HW34922, HW34926, HW34927, HW34929, HW34930, HW34931, HW34935, HW34937, HW34942, HW34943, HW34952, HW34956, HW34958, HW34961, HW34962, HW34964, HW34967, HW34969, HW34970, HW34971, HW34972, HW34973, HW34976, HW34978, HW34980, HW34981, HW34983, HW34984, HW34987, HW34988, HW34989, HW34993, HW34995, HW34998, HW34999, HW35001, HW35003, HW35004, HW35005, HW35006, HW35007, HW35008, HW35009, HW35010, HW35011, HW35013, HW35014, HW35015, HW35017, HW35018, HW35020, HW35022, HW35023, HW35026, HW35027, HW35029, HW35030, HW35036, HW35037, HW35042, HW35044, HW35045, HW35046, HW35047, HW35048, HW35050, HW35051, HW35053, HW35055, HW35058, HW35059, HW35060, HW35063, HW35066, HW35069, HW35071, HW35072, HW35073, HW35074, HW35075, HW35076, HW35077, HW35078, HW35079, HW35081, HW35082, HW35084, HW35087, HW35088, HW35089, HW35092, HW35096, HW35098, HW35100, HW35101, HW35103, HW35104, HW35105, HW35106, HW35107, HW35109, HW35110, HW35111, HW35112, HW35113, HW35115, HW35116, HW35117, HW35118, HW35126, HW35129, HW35130, HW35132, HW35135, HW35140, HW35152, HW35153, HW35159, HW35160, HW35163, HW35165, HW35166, HW35167, HW35168, HW35169, HW35170, HW35172, HW35173, HW35174, HW35175, HW35176, HW35177, HW35178, HW35179, HW35180, HW35181, HW35182, HW35183, HW35184, HW35190, HW35192, HW35193, HW35194, HW35195, HW35198, HW35199, HW35203, HW35206, HW35219, HW35221, HW35222, HW35223, HW35224, HW35225, HW35226, HW35227, HW35229, HW35231, HW35232, HW35233, HW35234, HW35235, HW35236, HW35238, HW35239, HW35240, HW35241, HW35242, HW35243, HW35244, HW35245, HW35246, HW35247, HW35249, HW35253, HW35254, HW35255, HW35256, HW35257, HW35258, HW35259, HW35261, HW35262, HW35263, HW35264, HW35265, HW35266, HW35267, HW35268, HW35269, HW35270, HW35271, HW35273, HW35274, HW35276, HW35277, HW35280, HW35285, HW35286, HW35287, HW35288, HW35289, HW35291, HW35292, HW35293, HW35294, HW35295, HW35296, HW35299, HW35301, HW35302, HW35347, HW35354, HW35358, HW35399, HW35403, HW35406, HW35410, HW35413, HW35414, HW35415, HW35416, HW35417, HW35420, HW35422, HW35424, HW35425, HW35426, HW35427, HW35428, HW35429, HW35430, HW35431, HW35433, HW35434, HW35435, HW35436, HW35437, HW35438, HW35439, HW35440, HW35441, HW35442, HW35443, HW35444, HW35445, HW35446, HW35447, HW35448, HW35449, HW35450, HW35451, HW35452, HW35453, HW35454, HW35455, HW35456, HW35457, HW35459, HW35460, HW35461, HW35462, HW35463, HW35466, HW35469, HW35471, HW35472, HW35473, HW30051, HW30066, HW30169, HW30330, HW30573, HW30605, HW30613, HW30628, HW30677, HW30700, HW30703, HW30884, HW30904, HW30912, HW30992, HW30999, HW31004, HW31013, HW31038, HW31046, HW31053, HW31060, HW31149, HW31151, HW31199, HW31225, HW31230, HW31321, HW31367, HW31407, HW31463, HW31537  GTIN 00888707003261, Serial Numbers: HW40002, HW40004, HW40006, HW40008, HW40009, HW40010, HW40012, HW40013, HW40015, HW40016, HW40017, HW40018, HW40019, HW40021, HW40022, HW40023, HW40024, HW40025, HW40026, HW40028, HW40030, HW40032, HW40033, HW40035, HW40036, HW40037, HW40038, HW40039, HW40041, HW40042, HW40043, HW40044, HW40045, HW40046, HW40047, HW40048, HW40049, HW40050, HW40051, HW40054, HW40055, HW40057, HW40058, HW40059, HW40060, HW40061, HW40062, HW40063, HW40064, HW40065, HW40066, HW40067, HW40068, HW40069, HW40070, HW40071, HW40072, HW40073, HW40074, HW40075, HW40076, HW40077, HW40078, HW40079, HW40080, HW40081, HW40082, HW40083, HW40084, HW40085, HW40086, HW40087, HW40088, HW40089, HW40090, HW40091, HW40092, HW40093, HW40094, HW40095, HW40096, HW40097, HW40098, HW40099, HW40100, HW40102, HW40103, HW40105, HW40106, HW40107, HW40108, HW40109, HW40110, HW40111, HW40112, HW40113, HW40114, HW40115, HW40116, HW40117, HW40118, HW40119, HW40120, HW40121, HW40122, HW40123, HW40124, HW40125, HW40126, HW40127, HW40128, HW40129, HW40130, HW40131, HW40132, HW40135, HW40136, HW40137, HW40138, HW40139, HW40140, HW40142, HW40143, HW40144, HW40145, HW40146, HW40147, HW40148, HW40149, HW40150, HW40151, HW40152, HW40153, HW40154, HW40155, HW40156, HW40157, HW40158, HW40159, HW40160, HW40161, HW40163, HW40164, HW40165, HW40166, HW40167, HW40168, HW40169, HW40170, HW40171, HW40172, HW40174, HW40175, HW40176, HW40177, HW40178, HW40179, HW40180, HW40181, HW40182, HW40184, HW40185, HW40186, HW40187, HW40188, HW40189, HW40190, HW40191, HW40192, HW40193, HW40194, HW40195, HW40196, HW40197, HW40198, HW40199, HW40200, HW40201, HW40202, HW40203, HW40204, HW40206, HW40207, HW40208, HW40209, HW40210, HW40211, HW40212, HW40213, HW40214, HW40215, HW40217, HW40218, HW40219, HW40220, HW40222, HW40223, HW40224, HW40225, HW40226, HW40227, HW40228, HW40229, HW40230, HW40231, HW40232, HW40233, HW40234, HW40235, HW40236, HW40237, HW40238, HW40239, HW40240, HW40241, HW40242, HW40243, HW40244, HW40245, HW40246, HW40247, HW40248, HW40249, HW40250, HW40251, HW40252, HW40253, HW40254, HW40255, HW40256, HW40257, HW40258, HW40259, HW40260, HW40261, HW40262, HW40263, HW40264, HW40265, HW40266, HW40267, HW40268, HW40269, HW40270, HW40271, HW40272, HW40273, HW40274, HW40275, HW40276, HW40277, HW40278, HW40279, HW40280, HW40281, HW40282, HW40283, HW40284, HW40285, HW40286, HW40287, HW40288, HW40289, HW40290, HW40291, HW40292, HW40293, HW40294, HW40295, HW40296, HW40297, HW40298, HW40299, HW40300, HW40301, HW40302, HW40303, HW40304, HW40305, HW40306, HW40307, HW40308, HW40309, HW40310, HW40311, HW40312, HW40313, HW40314, HW40315, HW40316, HW40317, HW40318, HW40319, HW40320, HW40321, HW40322, HW40323, HW40324, HW40325, HW40326, HW40327, HW40328, HW40329, HW40330, HW40331, HW40332, HW40333, HW40334, HW40335, HW40337, HW40338, HW40339, HW40340, HW40341, HW40359, HW40360, HW40361, HW40362, HW40364, HW40371, HW40372, HW40373, HW40375, HW40376, HW40377, HW40378, HW40379, HW40380, HW40381, HW40382, HW40384, HW40385, HW40386, HW40387, HW40388, HW40389, HW40390, HW40391, HW40392, HW40393, HW40394, HW40395, HW40396, HW40397, HW40399, HW40400, HW40401, HW40402, HW40403, HW40404, HW40405, HW40406, HW40407, HW40408, HW40409, HW40410, HW40411, HW40432, HW40433, HW40434, HW40435, HW40436, HW40437, HW40438, HW40440, HW40441, HW40442, HW40443, HW40444, HW40445, HW40446, HW40447, HW40448, HW40449, HW40451, HW40452, HW40453, HW40454, HW40455, HW40456, HW40457, HW40460, HW40461, HW40462, HW40463, HW40464, HW40466, HW40467, HW40468, HW40469, HW40470, HW40481, HW40482, HW40483, HW40484, HW40485, HW40486, HW40487, HW40488, HW40489, HW40490, HW40491, HW40492, HW40493, HW40494, HW40496, HW40497, HW40498, HW40499, HW40500, HW40501, HW40502, HW40503, HW40504, HW40505, HW40506, HW40507, HW40508, HW40509, HW40510, HW40511, HW40512, HW40513, HW40514, HW40515, HW40516, HW40517, HW40518, HW40519, HW40520, HW40521, HW40522, HW40523, HW40524, HW40525, HW40526, HW40527, HW40528, HW40529, HW40530, HW40531, HW40532, HW40533, HW40534, HW40535, HW40536, HW40537, HW40538, HW40539, HW40540, HW40541, HW40542, HW40543, HW40544, HW40545, HW40546, HW40547, HW40548, HW40549, HW40550, HW40551, HW40558, HW40559, HW40560, HW40561, HW40562, HW40563, HW40566, HW40567, HW40568, HW40569, HW40570, HW40571, HW40572, HW40573, HW40574, HW40575, HW40576, HW40577, HW40578, HW40581, HW40582, HW40583, HW40584, HW40585, HW40589, HW40590, HW40591, HW40592, HW40593, HW40594, HW40595, HW40596, HW40597, HW40598, HW40601, HW40605, HW40606, HW40610, HW40616, HW40617, HW40620, HW40621, HW40622, HW40623, HW40627, HW40628, HW40629, HW40630, HW40631, HW40633, HW40634, HW40635, HW40636, HW40637, HW40638, HW40639, HW40640, HW40641, HW40642, HW40643, HW40644, HW40645, HW40646, HW40647, HW40648, HW40671, HW40672, HW40673, HW40674, HW40676, HW40677, HW40678, HW40679, HW40680, HW40681, HW40682, HW40683, HW40684, HW40685, HW40686, HW40687, HW40688, HW40689, HW40690, HW40691, HW40692, HW40693, HW40694, HW40695, HW40696, HW40697, HW40698, HW40699, HW40700, HW40703, HW40704, HW40705, HW40706, HW40707, HW40708, HW40709, HW40710, HW40711, HW40712, HW40713, HW40714, HW40715, HW40716, HW40717, HW40718, HW40719, HW40720, HW40721, HW40722, HW40723, HW40724, HW40725, HW40726, HW40727, HW40728, HW40729, HW40730, HW40731, HW40732, HW40733, HW40734, HW40735, HW40736, HW40737, HW40738, HW40739, HW40740, HW40741, HW40742, HW40743, HW40744, HW40745, HW40746, HW40747, HW40748, HW40749, HW40750, HW40751, HW40752, HW40753, HW40754, HW40755, HW40756, HW40757, HW40758, HW40759, HW40760, HW40761, HW40762, HW40763, HW40764, HW40766, HW40767, HW40768, HW40769, HW40770, HW40771, HW40772, HW40773, HW40774, HW40775, HW40776, HW40777, HW40778, HW40779, HW40780, HW40781, HW40783, HW40784, HW40785, HW40786, HW40790, HW40791, HW40792, HW40793, HW40794, HW40795, HW40796, HW40797, HW40798, HW40799, HW40800, HW40801, HW40802, HW40803, HW40804, HW40805, HW40806, HW40807, HW40808, HW40809, HW40810, HW40811, HW40812, HW40813, HW40814, HW40815, HW40817, HW40818, HW40819, HW40820, HW40821, HW40822, HW40823, HW40824, HW40825, HW40826, HW40827, HW40828, HW40829, HW40830, HW40831, HW40832, HW40833, HW40834, HW40837, HW40838, HW40839, HW40840, HW40841, HW40857, HW40858, HW40859, HW40860, HW40861, HW40862, HW40863, HW40864, HW40865, HW40866, HW40867, HW40868, HW40869, HW40870, HW40872, HW40873, HW40874, HW40875, HW40876, HW40877, HW40878, HW40879, HW40880, HW40882, HW40883, HW40884, HW40885, HW40886, HW40887, HW40888, HW40889, HW40890, HW40891, HW40892, HW40893, HW40894, HW40896, HW40897, HW40899, HW40902, HW40903, HW40904, HW40905, HW40906, HW40907, HW40908, HW40910, HW40911, HW40912, HW40913, HW40914, HW40915, HW40916, HW40917, HW40918, HW40919, HW40920, HW40921, HW40922, HW40923, HW40924, HW40925, HW40926, HW40927, HW40928, HW40929, HW40930, HW40931, HW40932, HW40933, HW40935, HW40936, HW40937, HW40939, HW40940, HW40941, HW40942, HW40943, HW40944, HW40946, HW40947, HW40948, HW40949, HW40962, HW40963, HW40964, HW40965, HW40966, HW40967, HW40968, HW40969, HW40970, HW40971, HW40972, HW40973, HW40974, HW40975, HW40976, HW40977, HW40979, HW40982, HW40983, HW40984, HW40985, HW40986, HW40987, HW40988, HW40989, HW40990, HW40991, HW40992, HW40993, HW40994, HW40995, HW40996, HW40997, HW40998, HW40999, HW41001, HW41002, HW41004, HW41005, HW41006, HW41007, HW41008, HW41009, HW41010, HW41011, HW41012, HW41014, HW41015, HW41016, HW41017, HW41018, HW41019, HW41020, HW41021, HW41022, HW41023, HW41024, HW41025, HW41027, HW41029, HW41030, HW41031, HW41032, HW41033, HW41034, HW41035, HW41037, HW41038, HW41039, HW41040, HW41042, HW41043, HW41044, HW41046, HW41051, HW41052, HW41053, HW41054, HW41055, HW41057, HW41058, HW41059, HW41060, HW41061, HW41062, HW41063, HW41064, HW41065, HW41066, HW41067, HW41068, HW41069, HW41070, HW41071, HW41072, HW41073, HW41075, HW41076, HW41077, HW41078, HW41080, HW41081, HW41084, HW41086, HW41088, HW41089, HW41090, HW41091, HW41092, HW41093, HW41097, HW41098, HW41099, HW41100, HW41102, HW41103, HW41104, HW41105, HW41106, HW41107, HW41108, HW41111, HW41112, HW41115, HW41118, HW41119, HW41120, HW41121, HW41122, HW41123, HW41124, HW41125, HW41126, HW41127, HW41128, HW41130, HW41131, HW41132, HW41133, HW41135, HW41136, HW41137, HW41138, HW41139, HW41140, HW41141, HW41142, HW41143, HW41144, HW41145, HW41146, HW41147, HW41148, HW41149, HW41150, HW41152, HW41153, HW41154, HW41155, HW41157, HW41158, HW41159, HW41160, HW41161, HW41162, HW41164, HW41165, HW41166, HW41167, HW41168, HW41169, HW41170, HW41171, HW41172, HW41173, HW41174, HW41176, HW41177, HW41178, HW41179, HW41180, HW41181, HW41182, HW41184, HW41185, HW41186, HW41187, HW41188, HW41189, HW41190, HW41193, HW41194, HW41195, HW41196, HW41197, HW41198, HW41199, HW41200, HW41201, HW41202, HW41203, HW41204, HW41205, HW41206, HW41207, HW41208, HW41210, HW41212, HW41213, HW41215, HW41216, HW41217, HW41218, HW41219, HW41220, HW41221, HW41223, HW41224, HW41225, HW41226, HW41227, HW41228, HW41229, HW41230, HW41231, HW41232, HW41233, HW41234, HW41235, HW41236, HW41237, HW41238, HW41239, HW41241, HW41242, HW41243, HW41244, HW41245, HW41246, HW41247, HW41248, HW41249, HW41250, HW41267, HW41268, HW41272, HW41273, HW41274, HW41275, HW41276, HW41277, HW41278, HW41279, HW41280, HW41281, HW41282, HW41283, HW41284, HW41285, HW41286, HW41287, HW41288, HW41289, HW41291, HW41293, HW41294, HW41295, HW41296, HW41297, HW41298, HW41299, HW41300, HW41301, HW41302, HW41303, HW41304, HW41305, HW41307, HW41310, HW41312, HW41318, HW41319, HW41320, HW41321, HW41322, HW41323, HW41324, HW41325, HW41326, HW41327, HW41329, HW41330, HW41331, HW41332, HW41333, HW41334, HW41336, HW41337, HW41338, HW41339, HW41341, HW41343, HW41344, HW41345, HW41346, HW41347, HW41348, HW41349, HW41350, HW41351, HW41352, HW41354, HW41355, HW41357, HW41358, HW41359, HW41360, HW41361, HW41362, HW41363, HW41364, HW41368, HW41369, HW41371, HW41372, HW41373, HW41374, HW41376, HW41377, HW41378, HW41379, HW41380, HW41381, HW41382, HW41383, HW41384, HW41385, HW41386, HW41387, HW41388, HW41389, HW41390, HW41391, HW41392, HW41393, HW41394, HW41395, HW41396, HW41398, HW41399, HW41400, HW41401, HW41402, HW41404, HW41405, HW41406, HW41407, HW41408, HW41409, HW41410, HW41412, HW41413, HW41414, HW41415, HW41416, HW41417, HW41418, HW41419, HW41420, HW41422, HW41423, HW41424, HW41425, HW41426, HW41427, HW41428, HW41429, HW41430, HW41431, HW41432, HW41433, HW41434, HW41435, HW41436, HW41437, HW41438, HW41439, HW41440, HW41441, HW41442, HW41443, HW41444, HW41445, HW41446, HW41447, HW41448, HW41449, HW41450, HW41452, HW41453, HW41454, HW41455, HW41456, HW41458, HW41459, HW41460, HW41461, HW41462, HW41463, HW41465, HW41466, HW41467, HW41468, HW41469, HW41470, HW41471, HW41472, HW41473, HW41474, HW41475, HW41476, HW41477, HW41478, HW41479, HW41480, HW41481, HW41482, HW41483, HW41484, HW41486, HW41488, HW41489, HW41490, HW41491, HW41492, HW41493, HW41494, HW41495, HW41496, HW41497, HW41498, HW41499, HW41500, HW41502, HW41503, HW41504, HW41505, HW41506, HW41507, HW41508, HW41509, HW41644, HW41645, HW41646, HW41648, HW41649, HW41650, HW41651, HW41653, HW41654  
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact MCS Customer Service
877-367-4823
Manufacturer Reason
for Recall		 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
FDA Determined
Cause 2		 Device Design
Action The firm disseminated a Medical Device Safety Alert by letter beginning on 04/03/2020. The notice explained he potential for damage that can occur during the procedure. Specifically, the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. The letter also provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure which was provided in Appendix A.
Quantity in Commerce 2614 units
Distribution Worldwide Distribution
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
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