Class 2 Device Recall Boston Scientific COGNIS CRTD

• Date Initiated by Firm: September 17, 2014
• Date Posted: October 18, 2014
• Recall Status: Terminated on February 20, 2015
• Recall Number: Z-0087-2015
• Recall Event ID: 69291
• PMA Number: P010012S165
• Product Classification: Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
• Product: Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. ; ; ; Product Usage:; Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
• Code Information: Model N106 - Serial numbers: 222276, 222277, 222279, 222280, 222282, 222283, 222286, 222289, 222290, 222291, 222292, 222293, 222295, 222311, 222312, 222314, 222315, 222316, 222318, 222320, 222321, 222324, 222325, 222335, 222338, 222340, 222342, 222343, 222346, 222361, 222363, 222366, 222372, 222374, 222409. Model N107 - Serial numbers: 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100293, 100294, 100295, 100297, 100298, 100299, 100300, 100301, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100311, 100312, 100314, 100315, 100317, 100318, 100319, 100320, 100321, 100322, 100324, 100325, 100327, 100328, 100329, 100330, 100331, 100333, 100334, 100335, 100336, 100408, 100409, 100410, 100411, 100413, 100414, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100425, 100426, 100427, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100441, 100442, 100445, 100446, 100447, 100448, 100449, 100450, 100451, 100453, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100488, 100489, 100492, 100494, 100495, 100496, 100497, 100498, 100499, 100500, 100501, 100503, 100505, 100506, 100507, 100509, 100518, 100525, 100527, 100531, 100534, 100535, 100536, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100546, 100547, 100548, 100549, 100550, 100551, 100554, 100555, 100556, 100557, 100558, 100559, 100562, 100563, 100564, 100565, 100566, 100567, 100854, 100855, 100856, 100857, 100858, 100860, 100862, 100863, 100864, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100872, 100873. Model N108 - Serial numbers: 666667, 666668, 666669, 666670, 666671, 666672, 666673, 666675, 666676, 666677, 666678, 666679, 666680, 666681, 666682, 666683, 666684, 666685, 666686, 666687, 666688, 666689, 666690, 666691, 666693, 666694, 666695, 666696, 666697, 666699, 666700, 666702, 666703, 666704, 666705, 666706, 666707, 666708, 666710, 666711, 666713, 666714, 666715, 666716, 666717, 666718, 666719, 666720, 666721. Model N118 - Serial numbers: , 565136, 565138, 565140, 565146, 565149, 565151, 565152, 565154, 565155, 565157, 565158, 565160, 565163, 565164, 565165, 565167, 565168, 565170, 565173, 565176, 565177, 565178, 565179, 565181, 565182, 565186, 565187, 565188, 565189, 565190, 565191, 565192, 565193, 565194, 565197, 565198, 565199, 565200, 565202, 565204, 565209, 565210, 565319, 565320, 565321, 565326, 565328, 565329, 565330, 565331, 565332, 565334, 565335, 565336, 565337, 565338, 565339, 565342, 565343, 565344, 565345, 565356, 565359, 565363, 565364, 565365, 565367, 565368, 565371, 565374, 565375, 565376, 565378, 565379, 565383, 565384, 565386, 565388, 565390, 565394, 565396, 565397, 565398, 565401, 565402, 565404, 565406, 565407, 565408, 565409, 565410, 565412, 565415, 565416, 565418, 565421, 565427, 565429, 565433, 565434, 565437, 565440, 565441, 565442, 565444, 565446, 565447, 565448, 565449, 565450, 565452, 565454, 565455, 565457, 565460, 565467, 565469, 565471, 565475, 565476, 565478, 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Model N119 - Serial numbers: 048289, 048292, 048294, 048295, 048296, 048297, 048298, 048299, 048300, 048302, 048303, 048304, 048306, 048307, 048308, 048309, 048310, 048311, 048312, 048313, 048314, 048315, 048318, 048319, 048323, 048325, 048326, 048330, 048332, 048336, 048337, 048338, 048341, 048344, 048408, 048410, 048412, 048413, 048414, 048415, 048416, 048418, 048419, 048420, 048422, 048423, 048425, 048426, 048428, 048430, 048434, 048436, 048440, 048442, 048444, 048447, 048534, 048535, 048537, 048538, 048539, 048540, 048541, 048542, 048543, 048545, 048546, 048547, 048548, 048550, 048551, 048552, 048553, 048554, 048555, 048558, 048560, 048561, 048563, 048564, 048565, 048567, 048570, 048571, 048673, 048676, 048679, 048680, 048681, 048686, 048689, 048691, 048693, 048695, 048698, 048699, 048700, 048701, 048704, 048705, 048707, 048708, 048709, 048710, 048711, 048712, 048713, 048715, 048716, 048720, 048724, 048725, 048726, 048793, 048794, 048812, 048815, 048817, 048818, 048819, 048820, 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976525, 976526, 976527, 976528, 976529, 976530, 976533, 976534, 976535, 976536, 976537, 976538, 976539, 976540, 976541, 976542, 976544, 976545, 976547, 976551, 976552, 976556, 976557, 976558, 976569, 976570, 976574, 976575, 976576, 976577, 976579, 976581, 976840, 976841, 976843, 976844, 976845, 976847, 976848, 976849, 976851, 976852, 976854, 976857, 976858, 976859, 976860, 976862, 976863, 976868, 976873, 976894, 976896, 976897, 976898, 976899, 976901, 976904, 976907, 976908, 976909, 976912, 976915, 976916, 976917, 976918, 976920, 976921, 976922, 976923, 976925, 976926, 976927, 976928, 976930, 976933, 977014, 977015, 977017, 977018, 977021, 977022, 977023, 977027, 977028, 977031, 977032, 977033, 977036, 977039, 977040, 977041, 977042, 977044, 977046, 977048, 977049, 977050, 977051, 977052, 977053, 977115, 977116, 977117, 977118, 977120, 977121, 977122, 977123, 977124, 977125, 977126, 977129, 977131, 977133, 977134, 977136, 977137, 977138, 977140, 977141, 977142, 977143, 977145, 977146, 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977845, 977846, 977849, 977850, 977894, 977895, 977896, 977897, 977900, 977902, 977903, 977904, 977906, 977929, 977930, 977931, 977932, 977933, 977934, 977935, 977937, 977939, 977940, 977942, 977943, 977944, 977945, 977946, 977947, 977948, 977950, 977951, 977953, 977954, 977955, 977956, 977957, 977958, 978019, 978020, 978023, 978024, 978027, 978029, 978030, 978031, 978032, 978194, 978195, 978198, 978199, 978202, 978206, 978389, 978391, 978393, 978395, 978396, 978397, 978398, 978401, 978404, 978407, 978409, 978410, 978412, 978413, 978414, 978415, 978416, 978417, 978419, 978420, 978422, 978423, 978424, 978427, 978428, 978429, 978430, 978431, 978433, 978435, 978436, 978438, 978440, 978441, 978443, 978445, 978446, 978447, 978448, 978449, 978451, 978453, 978454, 978456, 978457, 978458, 978459, 978460, 978462, 978463, 978465, 978468, 978469, 978470, 978471, 978472, 978473, 978474, 978475, 978476, 978477, 978479, 978480, 978481, 978484, 978486, 978487, 978488, 978489, 978490, 978491, 978492, 978493, 978495, 978499, 978500, 978501, 978503, 978505, 978508, 978549, 978551, 978553, 978555, 978557, 978560, 978561, 978563, 978564, 978566, 978567, 978568, 978569, 978571, 978573, 978574, 978575, 978576, 978577, 978578, 978580, 978581, 978582, 978583, 978584, 978585, 978586, 978590, 978592, 978593, 978594, 978595, 978596, 978597, 978598, 978600, 978602, 978606, 978607, 978608, 978609, 978610, 978612, 978616, 978617, 978618, 978621, 978623, 978624, 978625, 978626, 978627, 978689, 978690, 978692, 978693, 978694, 978695, 978696, 978698, 978700, 978701, 978702, 978705, 978707, 978709, 978711, 978712, 978714, 978715, 978716, 978717, 978718, 978963, 978964, 978965, 978967, 978969, 978970, 978971, 978972, 978973, 978974, 978976, 978978, 979019, 979020, 979023, 979024, 979025, 979026, 979027, 979032, 979036, 979037, 979038, 979039, 979040, 979041, 979042, 979043, 979045, 979046, 979047, 979048, 979049, 979051, 979054, 979058, 979099, 979101, 979102, 979104, 979105, 979107, 979389, 979391, 979392, 979394, 979395, 979396, 979398, 979399, 979400, 979401, 979406, 979407, 979409, 979411, 979412, 979415, 979417, 979418, 979519, 979520, 979521, 979522, 979523, 979525, 979526, 979528, 979530, 979532, 979536, 979537, 979599, 979601, 979602, 979603, 979604, 979605, 979606, 979607, 979608, 979611, 979613, 979615, 979616, 979617, 979619, 979621, 979622, 979623, 979624, 979625, 979626, 979627, 979628, 979692, 979693, 979694, 979695, 979697, 979698, 979699, 979700, 979702, 979703, 979706, 979709, 979710, 979711, 979712, 979713, 979714, 979716, 979717, 979718, 979741, 979742, 979745, 979746, 979747, 979748, 979750, 979753, 979754, 979756, 979757, 979759, 979761, 979762, 979764, 979766, 979767, 979769, 979770, 979772, 979774, 979775, 979776, 979778, 979779, 979780, 979781, 979804, 979809, 979810, 979811, 979812, 979813, 979817, 979818, 979835, 979836, 979839, 979840, 979841, 979842, 979846, 979847, 979850, 979851, 979853, 979856, 979857, 979858, 979860, 979861, 979862, 979863, 979864, 979865, 979866, 979868, 979869, 979871, 979872, 979873, 979874, 979876, 979878, 979879, 979880, 979881, 979882, 979883, 980105, 980107, 980108, 980109, 980110, 980111, 980114, 980115, 980116, 980119, 980120, 980121, 980122, 980123, 980126, 980127, 980129, 980520, 980522, 980523, 980524, 980525, 980527, 980529, 980530, 980532, 980533, 980534, 980536, 980539, 980540, 980542, 980544, 980545, 980549, 980550, 980551, 980553, 980557, 980558, 980560, 980561, 980562, 980564, 980565, 980566, 980567, 980568, 980569, 980571, 980572, 980573, 980574, 980575, 980577, 980578, 980650, 980651, 980652, 980653, 980657, 980658, 980660, 980662, 980663, 980665, 980666, 980667, 980675, 980676, 980677, 980678, 980679, 980695, 980697, 980699, 980701, 980703, 980704, 980705, 980706, 980707, 980709, 980713, 980714, 980855, 980857, 980858, 980859, 980862, 980863, 980865, 980866, 980867, 980868, 980872, 980873, 980874, 980875, 980876, 980877, 980878, 980880, 980881, 980882, 980883, 980886, 980889, 980890, 980891, 980892, 980893, 980894, 980895, 980896, 980897, 980898, 980900, 980901, 980902, 981340, 981341, 981342, 981343, 981344, 981345, 981347, 981348, 981349, 981351, 981352, 981353, 981354, 981355, 981405, 981406, 981407, 981408, 981410, 981411, 981412, 981414, 981415, 981417, 981419, 981420, 981421, 981470, 981471, 981473, 981475, 981476, 981477, 981478, 981479, 981480, 981481, 981482, 981483, 981484, 981487, 981488, 981490, 981492, 981493, 981494, 981495, 981496, 981498, 981499, 981500, 981501, 981502, 981503, 981831, 981832, 981833, 981834, 981836, 981838, 981839, 981840, 981901, 981903, 981904, 981905, 981906, 981907, 981908, 981909, 981910, 981911, 981913, 981914, 981915, 981917, 981920, 981921, 981922, 981924, 981925, 981927, 981930, 981931, 981932, 981933, 981935, 981938, 981940, 981941, 981942, 981943, 981944, 981947, 981948, 981950, 981951, 981952, 981955, 981958, 981959, 981961, 981963, 981964, 981966, 981967, 981968, 981971, 981972, 981975, 981977, 981979, 981980, 981981, 981983, 981985, 981986, 981989, 981994, 981996, 981997, 981998, 982338, 982340, 982341, 982342, 982343, 982344, 982345, 982346, 982351, 982354, 982589, 982590, 982592, 982594, 982595, 982596, 982597, 982598, 982599, 982602, 982603, 982604, 982605, 982607, 982609, 982610, 982612, 982613, 982614, 982615, 982618, 982619, 982621, 982623, 982624, 982626, 982627, 982628, 982629, 982633, 982636, 982637, 982640, 982641, 982642, 982643, 982647, 982648, 982649, 982650, 982651, 982652, 982653, 982654, 982657, 982658, 982659, 982661, 982662, 982663, 982665, 982666, 982667, 982668, 982670, 982671, 982673, 982678, 982681, 982683, 982685, 982686, 982687, 982688, 982692, 982694, 982695, 982696, 982697, 982698, 982699, 982701, 982702, 982703, 982704, 982705, 982706, 982707, 982708, 982709, 982710, 982711, 982712, 982713, 982714, 982715, 982716, 982767, 982769, 982770, 982772, 982773, 982774, 982776, 982779, 982780, 982782, 982785, 982786, 982787, 982790, 982791, 982792, 982793, 982794, 982796, 982798, 982799, 982800, 982801, 982802, 982803, 982806, 982809, 982810, 982812, 982813, 982814, 982816, 982858, 982861, 982864, 982865, 982866, 982867, 982868, 982869, 982871, 982872, 982874, 982877, 982880, 982884, 982885, 982886, 982977, 982978, 982979, 982982, 982983, 982985, 982986, 982992, 982994, 982995, 982996, 983435, 983436, 983437, 983438, 983439, 983440, 983442, 983443, 983444, 983445, 983447, 983448, 983450, 983451, 983452, 983455, 983456, 983457, 983463, 983464, 983465, 983467, 983468, 983470, 983471, 983472, 983473, 983475, 983477, 983478, 983479, 983480, 983482, 983483, 983486, 983487, 983489, 983492, 983494, 983495, 983496, 983499, 983500, 983501, 983503, 983504, 983505, 983506, 983507, 983508, 983510, 983511, 983512, 983513, 983517, 983518, 983520, 983521, 983522, 983524, 983595, 983596, 983600, 983601, 983603, 983604, 983605, 983606, 983607, 983608, 983609, 983661, 983662, 983663, 983664, 983665, 983666, 983667, 983668, 983670, 983671, 983672, 983673, 983674, 983676, 983678, 983679, 983680, 983681, 983682, 983684, 983686, 983687, 983689, 983712, 983713, 983716, 983718, 983720, 983721, 983723, 983724, 983725, 983726, 983728, 983730, 983731, 983732, 983733, 983734, 983735, 983736, 983737, 983738, 983739, 983740, 983741, 983742, 983744, 983805, 983808, 983810, 983812, 983814, 983816, 983817, 983818, 983819, 983820, 983821, 983822, 983823, 983826, 983828, 983829, 983831, 983833, 983834, 983835, 983836, 983837, 983838, 983839, 983840, 983841, 983842, 983843, 983844, 983946, 983948, 983949, 983950, 983951, 983953, 983954, 983955, 983956, 983957, 983958, 983959, 983960, 983961, 983962, 983965, 983966, 983967, 983968, 983971, 983972, 983973, 983974, 983977, 983980, 983981, 983982, 983983, 983984, 983985, 983986, 983987, 983988, 983989, 983991, 983992, 983993, 983994, 983995, 983997, 983998, 984003, 984004, 984005, 984006, 984008, 984009, 984012, 984013, 984014, 984016, 984018, 984020, 984021, 984022, 984023, 984026, 984027, 984028, 984030, 984031, 984033, 984035, 984036, 984037, 984039, 984040, 984041, 984067, 984068, 984069, 984074, 984075, 984077, 984078, 984079, 984082, 984083, 984366, 984367, 984370, 984371, 984372, 984373, 984374, 984376, 984379, 984380, 984381, 984382, 984383, 984385, 984387, 984391, 984392, 984394, 984396, 984397, 984398, 984400, 984401, 984403, 984404, 984405, 984406, 984407, 984408, 984410, 984412, 984413, 984415, 984416, 984417, 984418, 984419, 984420, 984423, 984424, 984608, 984609, 984610, 984611, 984612, 984613, 984615, 984616, 984617, 984618, 984620, 984621. Model P106 - Serial numbers: 001589, 001590, 001591, 001592, 001594, 001596, 001597, 001598, 001599, 001600, 001601, 001602, 001603, 001605, 001606, 001607, 001608, 001609, 001610, 001611, 001612, 001613, 001615, 001616, 001617, 001618, 001619, 001621, 001622, 001623, 001624, 001625, 001626, 001627, 001628, 001629, 001632, 001633, 001635, 001636, 001638, 001639, 001641, 001642, 001643, 001644, 001645, 001646, 001647, 001648, 001650, 001652, 001653, 001654, 001655, 001656, 001657, 001658, 001659, 001660, 001661, 001662, 001663, 001664, 001665, 001666, 001667, 001668, 001669, 001670, 001671, 001672, 001673, 001674, 001675, 001676, 001678, 001679, 001681, 001682, 001684, 001685, 001686, 001687, 001689, 001690, 001691, 001692, 001693, 001694, 001695, 001696, 001697, 001698, 001699, 001700, 001701, 001702, 001703, 001704, 001705, 001706, 001707, 001708, 001709, 001710, 001711, 001712, 001713, 001714, 001715, 001716, 001717, 001718, 001719, 001721, 001722, 001723, 001724, 001726, 001727, 001729, 001730, 001733, 001735, 001736, 001739, 001740, 001741, 001742, 001743, 001745, 001746, 001747, 001748, 001749, 001750, 001751, 001752, 001753, 001754, 001755, 001756, 001757, 001758, 001759, 001760, 001761, 001762, 001763, 001765, 001766, 001767, 001768, 001769, 001770, 001771, 001772, 001773, 001774, 001775, 001777, 001779, 001781, 001782, 001783, 001785, 001786, 001788, 001790, 001791, 001792, 001795, 001796, 001797, 001798, 001799, 001800, 001801, 001802, 001803, 001804, 001805, 001806, 001807, 001808, 001809, 001810, 001812, 001813, 001814, 001815, 001816, 001818, 001819, 001823, 001934, 001935, 001937, 001938, 001940, 001941, 001942, 001943, 001944, 001945, 001946, 001947, 001949, 001950, 001951, 001952, 001955, 001956, 001957, 001958, 001959, 001961, 001962, 001963, 001964, 001965, 001966, 001967, 001968, 001969, 001970, 001972, 001973, 001974, 001975, 001976, 001977, 001978, 001980, 001981, 001982, 001985, 001986, 001987, 001988, 001989, 001990, 001991, 001992, 001994, 001996, 001997, 001998, 001999, 002000, 002001, 002003, 002004, 002005, 002006, 002007, 002009, 002010, 002011, 002012, 002013, 002014, 002015, 002016, 002017, 002019, 002020, 002022, 002024, 002026, 002027, 002028, 002029, 002031, 002032, 002033, 002034, 002035, 002036, 002038, 002040, 002041, 002042, 002043, 002044, 002045, 002046, 002048, 002049, 002050, 002051, 002052, 002053, 002054, 002055, 002060, 002061, 002063, 002064, 002065, 002066, 002067, 002068, 002069, 002071, 002073, 002074, 002075, 002077, 002078, 002080, 002081, 002085, 002087, 002088, 002089, 002090, 002091, 002092, 002094, 002095, 002096, 002098, 002101, 002102, 002103, 002104, 002105, 002106, 002107, 002108, 002109, 002110, 002111, 002112, 002113, 002114, 002115, 002116, 002118, 002119, 002120, 002121, 002124, 002125, 002126, 002127, 002128, 002129, 002130, 002131, 002132, 002133, 002134, 002136, 002137, 002140, 002141, 002142, 002143, 002144, 002145, 002146, 002148, 002151, 002152, 002154, 002158, 002159, 002161, 002162, 002163, 002164, 002165, 002166, 002171, 002172, 002174, 002176, 002178, 002179, 002180, 002181, 002182, 002183, 002184, 002186, 002187, 002188, 002189, 002190, 002191, 002192, 002193, 002194, 002196, 002198, 002199, 002200, 002201, 002202, 002203, 002564, 002565, 002566, 002569, 002570, 002571, 002572, 002573, 002575, 002577, 002580, 002582, 002583, 002584, 002585, 002586, 002587, 002588, 002589, 002590, 002591, 002592, 002593, 002594, 002595, 002596, 002597, 002598, 002599, 002601, 002602, 002603, 002604, 002605, 002606, 002607, 002608, 002609, 002610, 002611, 002612, 002613, 002614, 002615, 002617, 002618, 002619, 002620, 002621, 002622, 002623, 002624, 002625, 002626, 002627, 002628, 002629, 002630, 002631, 002632, 002633, 002634, 002635, 002636, 002637, 002639, 002640, 002641, 002642, 002643, 002644, 002645, 002646, 002647, 002648, 002649, 002650, 002651, 002652, 002653, 002654, 002655, 002656, 002657, 002658, 002659, 002660, 002661, 002662, 002664, 002665, 002666, 002667, 002668, 002669, 002670, 002671, 002672, 002673, 002674, 002675, 002677, 002678, 002679, 002680, 002681, 002684, 002685, 002686, 002687, 002688, 002689, 002690, 002691, 002692, 002693, 002694, 002695, 002696, 002697, 002698, 002699, 002701, 002702, 002703, 002704, 002705, 002706, 002708, 002709, 002710, 002711, 002712, 002713, 002714, 002716, 002718, 002719, 002720, 002721, 002723, 002724, 002725, 002727, 002728, 002729, 002730, 002732, 002733, 002734, 002735, 002737, 002739, 002741, 002743, 002744, 002746, 002747, 002748, 002749, 002751, 002753, 002755, 002756, 002758, 002759, 002760, 002761, 002762, 002763, 002764, 002765, 002766, 002767, 002769, 002770, 002772, 002774, 002775, 002776, 002777, 002779, 002780, 002781, 002783, 002784, 002785, 002786, 002787, 002788. Model P107 - Serial numbers: 008276, 009310, 009311, 009312, 009313, 009315, 009317, 009320, 009323, 009324, 009325, 009327, 009328, 009329, 009330, 009331, 009332, 009333, 009334, 009335, 009337, 009338, 009339, 009340, 009342, 009343, 009344, 009345, 009347, 009349, 009350, 009351, 009352, 009353, 009354, 009355, 009357, 009358, 009359, 009360, 009361, 009362, 009363, 009364, 009365, 009366, 009367, 009368, 009369, 009490, 009491, 009492, 009493, 009494, 009495, 009496, 009497, 009498, 009499, 009500, 009501, 009502, 009503, 009504, 009505, 009506, 009507, 009508, 009509, 009510, 009512, 009514, 009516, 009517, 009518, 009519, 009540, 009541, 009542, 009543, 009545, 009546, 009547, 009548, 009549, 009550, 009551, 009553, 009554, 009555, 009556, 009557, 009558, 009559, 009560, 009561, 009562, 009564, 009565, 009566, 009567, 009568, 009569, 009570, 009571, 009572, 009573, 009574, 009576, 009577, 009578, 009579, 009580, 009581, 009582, 009583, 009584, 009585, 009586, 009587, 009588, 009589, 009590, 009591, 009592, 009593, 009594, 009595, 009596, 009597, 009598, 009599, 009600, 009601, 009602, 009603, 009604, 009605, 009606, 009607, 009608, 009609, 009781, 009782, 009785, 009786, 009787, 009788, 009790, 009791, 009792, 009794, 009795, 009796, 009797, 009798, 009799, 009800, 009801, 009803, 009804, 009805, 009806, 009807, 009809, 009810, 009811, 009812, 009813, 009814, 009815, 009817, 009818, 009819, 009821, 009823, 009824, 009825, 009826, 009827, 009828, 009829, 009830, 009891, 009892, 009893, 009894, 009895, 009896, 009897, 009898, 009899, 009900, 009901, 009902, 009903, 009904, 009905, 009906, 009907, 009908, 009909, 009910, 009911, 009914, 009915, 009916, 009917, 009918, 009919, 009920, 009921, 009922, 009923, 009924, 009925, 009926, 009927, 009928, 009929, 009930, 009932, 009933, 009934, 009935, 009936, 009937, 009939, 009940, 009941, 009942, 009943, 009944, 009945, 009946, 009947, 009948, 009949, 009950, 009991, 009992, 009993, 009994, 009995, 009996, 009997, 009998, 009999, 010000, 010001, 010002, 010003, 010005, 010006, 010007, 010008, 010009, 010010, 010011, 010012, 010013, 010014, 010015, 010056, 010057, 010058, 010059, 010060, 010061, 010062, 010064, 010065, 010066, 010067, 010068, 010069, 010070, 010071, 010074, 010075, 010077, 010078, 010079, 010080, 010081, 010082, 010083, 010084, 010085, 010086, 010087, 010089, 010090, 010091, 010092, 010093, 010094, 010096, 010097, 010098, 010099, 010100, 010101, 010102, 010103, 010104, 010105, 010106, 010108, 010109, 010110, 010111, 010112, 010113, 010114, 010115, 010116, 010117, 010118, 010119, 010120, 010122, 010123, 010124, 010125, 010126, 010127, 010128, 010129, 010131, 010132, 010133, 010134, 010135, 010136, 010137, 010138, 010139, 010140, 010141, 010142, 010143, 010144, 010145, 010146, 010147, 010148, 010149, 010150, 010151, 010152, 010153, 010154, 010155, 010156, 010157, 010158, 010159, 010160, 010161, 010162, 010163, 010164, 010165, 010166, 010167, 010168, 010169, 010170, 010171, 010172, 010173, 010174, 010175, 010176, 010177, 010178, 010179, 010180, 010181, 010182, 010183, 010184, 010185, 010186, 010187, 010188, 010189, 010190, 010191, 010192, 010193, 010194, 010195, 010272, 010273, 010274, 010275, 010276, 010278, 010279, 010281, 010282, 010283, 010284, 010285, 010286, 010287, 010288, 010289, 010290, 010291, 010292, 010293, 010294, 010295, 010296, 010297, 010299, 010300, 010301, 010302, 010303, 010305, 010306, 010307, 010308, 010309, 010310, 010311, 010312, 010313, 010314, 010315, 010316, 010317, 010318, 010319, 010320, 010321, 010322, 010323, 010324, 010325, 010326, 010327, 010328, 010329, 010330, 010331, 010389, 010390, 010391, 010392, 010394, 010395, 010396, 010397, 010398, 010399, 010400, 010401, 010402, 010403, 010405, 010406, 010407, 010408, 010409, 010410, 010411, 010412, 010413, 010414, 010415, 010417, 010418, 010663, 010664, 010665, 010666, 010667, 010668, 010669, 010671, 010672, 010696, 010697, 010698, 010699, 010700, 010703, 010704, 010705, 010706, 010707, 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011502, 011503, 011504, 011506, 011507, 011508, 011509, 011510, 011511, 011512, 011513, 011514, 011515, 011517, 011518, 011521, 011522, 011523, 011524, 011525, 011526, 011527, 011528, 011530, 011531, 011532, 014351, 014352, 014353, 014354, 014355, 014356, 014357, 014358, 014359, 014360, 014361, 014362, 014363, 014364, 014365, 014366, 014367, 014368, 014369, 014370, 014372, 014373, 014374, 014375, 014377, 014378, 014380, 014381, 014382, 014383, 014384, 014385, 014386, 014387, 014388, 014389, 014390, 014391, 014392, 014393, 014394, 014395, 014396, 014398, 014399, 014400, 014441, 014442, 014443, 014445, 014446, 014447, 014448, 014449, 014450, 014451, 014452, 014453, 014454, 014456, 014457, 014458, 014459, 014460, 014461, 014462, 014463, 014464, 014465, 014546, 014547, 014548, 014549, 014550, 014551, 014552, 014553, 014554, 014555, 014556, 014557, 014558, 014560, 014561, 014562, 014563, 014564, 014565, 014566, 014567, 014568, 014569, 014570, 014571, 014572, 014573, 014574, 014575, 014576, 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Model P108 - Serial numbers: 100355, 100356, 100357, 100358, 100359, 100360, 100361, 100364, 100365, 100366, 100367, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100377, 100378, 100379, 100381, 100382, 100383, 100384, 100386, 100387, 100388, 100389, 100390, 100391, 100392, 100393, 100394, 100397, 100398, 100399, 100400, 100402, 100403, 100404, 100405, 100406, 100407, 100409, 100410, 100411, 100412, 100413, 100414, 100415, 100416, 100417, 100418.100419, 100420, 100421, 100422, 100423, 100424, 100425, 100426, 100427, 100428, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100436, 100437, 100438, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448, 100449, 100450, 100451, 100452, 100453, 100454, 100455, 100457, 100459, 100460, 100461, 100462, 100463, 100465, 100466, 100467, 100469, 100470, 100471, 100472, 100473, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100483, 100484, 100485, 100486, 100487, 100488, 100489, 100490, 100491, 100492, 100493, 100494, 100495, 100496, 100498, 100499, 100500, 100501, 100502, 100503, 100504, 100506, 100508, 100509, 100510, 100511, 100512, 100514, 100515, 100517, 100518, 100519, 100520, 100521, 100522, 100523, 100524, 100526, 100527, 100528, 100529, 100530, 100531, 100532, 100533, 100534, 100535, 100536, 100537, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100545, 100546, 100547, 100548, 100551, 100552, 100553, 100554, 100555, 100557, 100558, 100559, 100560, 100561, 100562, 100563, 100564, 100565, 100566, 100567, 100568, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100578, 100579, 100580, 100581, 100582, 100584, 100585, 100587, 100588, 100589, 100590, 100591, 100592, 100593, 100594, 100595, 100596, 100597, 100598, 100600, 100601, 100602, 100603, 100604, 100605, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100615, 100616, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100626, 100627, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100637, 100638, 100639, 100640, 100642, 100643, 100644, 100646, 100647, 100648, 100649, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100659, 100660, 100661, 100662, 100663, 100664, 100665, 100666, 100668, 100669, 100670, 100671, 100672, 100673, 100674, 100676, 100677, 100678, 100679, 100680, 100681, 100682, 100683, 100685, 100686, 100687, 100688, 100690, 100692, 100693, 100694, 100695, 100696, 100698, 100699, 100700, 100701, 100703, 100704.
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: US Technical Services; 800-227-3422
• Manufacturer Reason for Recall: Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
• FDA Determined Cause: Component design/selection
• Action: Boston Scientific sent an Important Medical Device Information letter to physicians beginning September 17, 2014. The letter provided a summary of the issue, described clinical implications and expected device performance, and provided patient monitoring recommendations. Boston Scientific is introducing upgraded program software (Model 2868, version 3.04) that enhances the effectiveness of the Safety Architecture tools. Questions should be addressed to Boston Scientific Representative or Technical Services 1-800-227-3422 or tech.services@bsci.com.
• Quantity in Commerce: 31,144 total
• Distribution: Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LWP and Original Applicant = Boston Scientific Corp.