Class 2 Device Recall Boston Scientific COGNIS CRTD

• Date Initiated by Firm: August 29, 2013
• Date Posted: October 17, 2013
• Recall Status: Terminated on April 10, 2014
• Recall Number: Z-0025-2014
• Recall Event ID: 66171
• PMA Number: P010112S165
• 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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. ; ; Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
• Code Information: Model N118, Serial numbers: 559191, 559192, 559195, 559196, 559200, 559201, 559202, 559203, 559210, 559211, 559212, 559215, 559222, 559223, 559225, 559226, 559231, 559232, 559236, 559238, 559239, 559240, 559241, 559242, 559245, 559247, 559250, 559251, 559253, 559257, 559260, 559262, 559263, 559266, 559267, 559272, 559273, 559275, 559277, 559278, 559279, 559281, 559282, 559283, 559286, 559289, 559292, 559294, 559298, 559300, 559301, 559303, 559306, 559307, 559314, 559317, 559318, 559319, 559321, 559322, 559324, 559325, 559327, 559330, 559334, 559336, 559338, 559339, 559340, 559341, 559342, 559343, 559344, 559349, 559350, 559353, 559355, 559359, 559361, 559368, 559372, 559373, 559374, 559378, 559379, 559381, 559382, 559384, 559385, 559388, 559389, 559391, 559393, 559394, 559395, 559396, 559397, 559398, 559399, 559400, 559405, 559410, 559412, 559413, 559415, 559416, 559417, 559418, 559419, 559420, 559423, 559426, 559428, 559429, 559431, 559435, 559437, 559438, 559439, 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562707, 562708, 562709, 562710, 562714, 562715, 562717, 562719, 562720, 562724, 562726, 562727, 562728, 562729, 562731, 562732, 562733, 562735, 562738, 562739, 562741, 562744, 562746, 562748, 562751, 562756, 562757, 562760, 562761, 562763, 562764, 562767, 562771, 562772, 562777, 562778, 562779, 562780, 562784, 562785, 562786, 562787, 562788, 562790, 562792, 562793, 562795, 562797, 562798, 562802, 562804, 562805, 562806, 562807, 562808, 562809, 562810, 562811, 562813, 562814, 562818, 562820, 562821, 562824, 562825, 562827, 562828, 562829, 562830, 562832, 562836, 562841, 562844, 562847, 562851, 562852, 562854, 562855, 562857, 562858, 562859, 562860, 562861, 562862, 562863, 562866, 562869, 562871, 562872, 562873, 562874, 562878, 562879, 562880, 562882, 562884, 562885, 562887, 562889, 562892, 562893, 562894, 562896, 562898, 562900, 562901, 562905, 562906, 562907, 562908, 562909, 562910, 562911, 562912, 562915, 562916, 562919, 562921, 562922, 562923, 562924, 562931, 562935, 562936, 562937, 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564180, 564181, 564184, 564187, 564188, 564190, 564193, 564196, 564199, 564200, 564201, 564202, 564203, 564206, 564207, 564209, 564210, 564211, 564213, 564214, 564217, 564219, 564223, 564226, 564227, 564228, 564230, 564234, 564239, 564240, 564241, 564244, 564245, 564246, 564247, 564248, 564249, 564250, 564251, 564252, 564253, 564254, 564256, 564258, 564259, 564260, 564261, 564262, 564263, 564265, 564268, 564272, 564273, 564274, 564277, 564278, 564281, 564283, 564285, 564288, 564290, 564291, 564292, 564293, 564295, 564298, 564300, 564301, 564303, 564304, 564306, 564308, 564309, 564311, 564312, 564314, 564315, 564316, 564317, 564318, 564320, 564322, 564325, 564326, 564327, 564328, 564331, 564333, 564334, 564335, 564337, 564345, 564346, 564348, 564349, 564352, 564353, 564355, 564357, 564358, 564359, 564360, 564363, 564364, 564366, 564367, 564368, 564369, 564370, 564371, 564372, 564378, 564379, 564381, 564382, 564383, 564384, 564388, 564389, 564390, 564392, 564394, 564395, 564396, 564401, 564406, 564408, 564409, 564411, 564412, 564414, 564417, 564418, 564419, 564421, 564422, 564423, 564424, 564426, 564427, 564428, 564430, 564431, 564434, 564437, 564438, 564439, 564442, 564447, 564448, 564450, 564452, 564456, 564457, 564458, 564459, 564462, 564467, 564470, 564471, 564472, 564474, 564476, 564477, 564478, 564479, 564481, 564482, 564483, 564484, 564486, 564488, 564490, 564491, 564493, 564496, 564499, 564500, 564506, 564507, 564508, 564509, 564513, 564521, 564523, 564525, 564526, 564527, 564531, 564533, 564534, 564537, 564543, 564544, 564546, 564547, 564551, 564554, 564558, 564559, 564560, 564561, 564562, 564563, 564564, 564565, 564568, 564571, 564572, 564573, 564575, 564579, 564580, 564581, 564584, 564588, 564591, 564594, 564596, 564598, 564600, 564601, 564602, 564604, 564606, 564608, 564609, 564611, 564612, 564616, 564617, 564618, 564619, 564624, 564625, 564627, 564630, 564631, 564634, 564635, 564636, 564637, 564638, 564642, 564645, 564646, 564647, 564648, 564649, 564652, 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564890, 564892, 564893, 564894, 564896, 564897, 564898, 564900, 564901, 564902, 564904, 564905, 564906, 564907, 564908, 564909, 564910, 564913, 564919, 564920, 564921, 564922, 564923, 564924, 564926, 564927, 564930, 564932, 564933, 564934, 564935, 564937, 564938, 564940, 564941, 564944, 564947, 564948, 564950, 564952, 564954, 564955, 564957, 564958, 564959, 564960, 564961, 564966, 564967, 564968, 564969, 564970, 564971, 564972, 564973, 564974, 564976, 564979, 564980, 564981, 564983, 564986, 564987, 564988, 564989, 564991, 564992, 564994, 564996, 564997, 564998, 565001, 565003, 565004, 565005, 565007, 565008, 565009, 565010, 565011, 565013, 565015, 565018, 565020, 565021, 565022, 565023, 565025, 565026, 565027, 565029, 565030, 565033, 565035, 565037, 565038, 565039, 565042, 565047, 565051, 565052, 565053, 565056, 565057, 565059, 565062, 565063, 565064, 565065, 565068, 565069, 565070, 565071, 565072, 565074, 565075, 565078, 565079, 565081, 565082, 565084, 565087, 565088, 565091, 565093, 565096, 565097, 565098, 565102, 565103, 565104, 565106, 565108, 565109, 565110, 565112, 565115, 565117, 565118, 565121, 565122, 565123, 565124, 565131, 565134, 565135, 578193, 578194, 578195, 578196, 578198, 578200, 578203, 578205, 578207, 578208, 578211, 578212, 578213, 578214, 578215, 578217, 578222, 578224, 578225, 578226, 578228, 578230, 578235, 578236, 578239, 578240, 578345, 578347, 578351, 578353, 578354, 578358, 578359, 578360, 578361, 578365, 578366, 578367, 578380, 578386, 578388, 578389, 578391, 578396, 578399, 578400, 578405, 578406, 578407, 578408, 578411, 578413, 578416, 578417, 578418, 578422, 578423, 578424, 578428, 578429, 578432, 578433, 578434, 578436, 578437, 578438, 578439, 578440, 578442, 578444, 578446, 578451, 578452, 578456, 578458, 578459, 578464, 578465, 578468, 578472, 578473, 578478, 578480, 578484, 578485, 578486, 578489, 578491, 578492, 578494, 578495, 578496, 578639, 578640, 578643, 578644, 578646, 578647, 578648, 578649, 578650, 578651, 578655, 578656, 578657, 578658, 578659, 578660, 578661, 578663, 578664, 578665, 578667, 578672, 578674, 578675, 578676, 578677, 578681, 578683, 578685, 578687, 578688, 578689, 578690, 578691, 578695, 578698, 578699, 578700, 578703, 578704, 578705, 578709, 578711, 578712, 578714, 578717, 578718, 578719, 578721, 578722, 578724, 578726, 578727, 578728, 578729, 578731, 578732, 578733, 578737, 578740, 578741, 578742, 578744, 578745, 578746, 578747, 578748, 578749, 578751, 578752, 578755, 578756, 578757, 578758, 578760, 578762, 578763, 578764, 578767, 578768, 578769, 578770, 578772, 578774, 578775, 578776, 578777, 578778, 578781, 578782, 578783, 578784, 578785, 578788, 578789, 578790, 578791, 578793, 578794, 578795, 578797, 578798, 578799, 578800, 578801, 578802, 578804, 578806, 578807, 578808, 578810, 578812, 578814, 578815, 578816, 578817, 578819, 578820, 578821, 578822, 578823, 578825, 578827, 578828, 578830, 578833, 578834, 578835, 578836, 578837, 578838, 578839, 578842, 578844, 578845, 578848, 578850, 578851, 578853, 578854, 578855, 578856, 578857, 578858, 578859, 578860, 578861, 578862, 578863, 578864, 578865, 578867, 578869, 578871, 578872, 578873, 578874, 578875, 578876, 578877, 578881, 578884, 578885, 578886, 578888, 578889, 578890, 578891, 578892, 578894, 578896, 578897, 578898, 578899, 578900, 578901, 578902, 578903, 578906, 578907, 578908, 578909, 578913, 578914, 578916, 578917, 578918, 578919, 578920, 578922, 578924, 578925, 578926, 578929, 578930, 578931, 578933, 578938, 578939, 578941, 578942, 578943, 578944, 578946, 578947, 578948, 578949, 578950, 578951, 578952, 578954, 578955, 578957, 578959, 578960, 578961, 578963, 578964, 578965, 578966, 578968, 578969, 578970, 578972, 578974, 578976, 578977, 578978, 578979, 578980, 578981, 578985, 578986, 578990, 578991, 578992, 578993, 578995, 579003, 579004, 579005, 579006, 579007, 579008, 579010, 579012, 579014, 579015, 579016, 579017, 579018, 579019, 579021, 579022, 579023, 579024, 579025, 579026, 579027, 579028, 579029, 579031, 579032, 579034, 579035, 579036, 579038, 579039, 579046, 579047, 579048, 579052, 579054, 579055, 579058, 579059, 579060, 579061, 579062, 579063, 579065, 579068, 579070, 579071, 579074, 579075, 579077, 579078, 579079, 579080, 579083, 579084, 579085, 579086, 579087, 579088, 579089, 579090, 579095, 579097, 579098, 579099, 579100, 579101, 579104, 579105, 579106, 579108, 579109, 579111, 579112, 579114, 579116, 579117, 579118, 579119, 579120, 579122, 579123, 579124, 579125, 579126, 579127, 579128, 579130, 579131, 579134, 579136, 579137, 579138, 579140, 579141, 579143, 579144, 579146, 579152, 579154, 579155, 579156, 579159, 579160, 579164, 579167, 579169, 579172, 579180, 579183, 579186, 579191, 579197, 579198, 579200, 579201, 579202, 579203, 579204, 579205, 579212, 579218, 579221, 579222, 579223, 579225, 579228, 579231, 579232, 579233, 579235, 579236, 579238, 579240, 579243, 579244, 579247, 579248, 579250, 579251, 579252, 579253, 579256, 579257, 579259, 579260, 579261, 579447, 579449, 579450, 579452, 579455, 579456, 579462, 579463, 579464, 579465, 579469, 579470, 579471, 579472, 579473, 579475, 579477, 579478, 579480, 579481, 579484, 579485, 579486, 579488, 579489, 579490, 579493, 579494, 579500, 579503, 579504, 579506, 579512, 579513, 579515, 579517, 579518, 579520, 579522, 579524, 579526, 579527, 579528, 579529, 579531, 579541, 579544, 579546, 579550, 579551, 579552, 579554, 579555, 579560, 579566, 579568, 579569, 579570, 579571, 579573, 579586, 579589, 579590, 579591, 579597, 579598, 579604, 579606, 579608, 579609, 579611, 579614, 579616, 579623, 579625, 579628, 579644, 579646, 579648, 579650, 579651, 579652, 579654, 579662, 579663, 579669, 579671, 579673, 579675, 579678, 579684, 579691, 579692, 579696, 579704, 579711, 579715, 579717, 579720, 579723, 579729, 579732, 579733, 579739, 579740, 579742, 579743, 579744, 579746, 579752, 579755, 579765, 579773, 579774, 579775, 579777, 579781, 579784, 579786, 579792, 579796, 579797, 579801, 579804, 579805, 579806, 579807, 579811, 579815, 579819, 579828, 579842, 579845, 579846, 579847, 579849, 579854, 579859, 579863, 579870. Model N119, Serial Numbers: 000036, 000085, 000087, 000088, 000090, 000091, 000093, 000094, 000096, 000097, 000098, 000103, 000106, 000107, 000112, 000114, 000115, 000117, 000119, 000120, 000121, 000125, 000128, 000132, 000133, 000134, 000136, 000138, 000139, 000142, 000143, 000145, 000146, 000148, 000150, 000151, 000154, 000155, 000156, 000160, 000163, 000167, 000168, 000171, 000173, 000174, 000175, 000176, 000177, 000181, 000182, 000184, 000187, 000188, 000196, 000197, 000198, 000200, 000202, 000203, 000204, 000205, 000208, 000209, 000213, 000215, 000218, 000219, 000220, 000221, 000222, 000224, 000225, 000226, 000228, 000229, 000230, 000231, 000233, 000234, 000236, 000239, 000241, 000243, 000244, 000247, 000248, 000249, 000251, 000252, 000253, 000255, 000256, 000259, 000260, 000263, 000264, 000265, 000269, 000270, 000273, 000274, 000275, 000277, 000280, 000285, 000289, 000290, 000291, 000294, 000296, 000298, 000302, 000303, 000304, 000305, 000306, 000308, 000310, 000311, 000312, 000313, 000315, 000319, 000321, 000323, 000324, 000326, 000328, 000330, 000332, 000335, 000338, 000339, 000341, 000342, 000344, 000346, 000349, 000352, 000353, 000354, 000358, 000361, 000362, 000363, 000366, 000368, 000373, 000374, 000375, 000378, 000383, 000384, 000385, 000387, 000389, 000393, 000394, 000401, 000402, 000403, 000404, 000405, 000406, 000409, 000410, 000411, 000412, 000417, 000419, 000424, 000426, 000428, 000429, 000432, 000433, 000438, 000440, 000443, 000445, 000447, 000452, 000453, 000454, 000456, 000459, 000462, 000463, 000464, 000466, 000467, 000468, 000469, 000475, 000477, 000479, 000480, 000481, 000482, 000483, 000486, 000490, 000491, 000492, 000493, 000498, 000500, 000503, 000521, 000522, 000525, 000526, 000527, 000530, 000531, 000532, 000560, 000561, 000563, 000568, 000569, 000573, 000574, 000575, 000576, 000578, 000607, 000608, 000609, 000611, 000613, 000616, 000620, 000621, 000622, 000623, 000624, 000626, 000629, 000631, 000633, 000636, 000637, 000642, 000643, 000848, 000850, 000851, 000853, 000855, 000856, 000857, 000858, 000861, 000864, 000866, 000869, 000872, 000876, 000879, 000881, 000883, 000884, 000886, 001007, 001008, 001011, 001012, 001137, 001138, 001140, 001144, 001147, 001149, 001150, 001154, 001157, 001160, 001163, 001164, 001165, 001166, 001168, 001169, 001171, 001172, 001173, 001174, 001175, 001176, 001268, 001269, 001273, 001274, 001275, 001278, 001280, 001284, 001286, 001547, 001548, 001549, 001550, 001552, 001555, 001556, 001557, 001558, 001559, 001560, 001563, 001567, 001569, 001570, 001612, 001614, 001616, 001618, 001619, 001620, 001621, 001622, 001624, 001626, 006074, 029949, 029950, 029951, 029952, 029956, 029958, 029959, 029960, 029962, 029963, 029965, 029967, 030070, 030071, 030074, 030075, 030076, 030077, 030078, 030079, 030080, 030083, 030084, 030085, 030087, 030089, 030091, 030092, 030094, 030095, 030097, 030100, 030101, 030102, 030104, 030105, 030106, 030107, 030128, 030129, 030131, 030133, 030134, 030135, 030136, 030137, 030159, 030160, 030161, 030162, 030163, 030164, 030165, 030166, 030167, 030168, 030170, 030172, 030173, 030174, 030175, 030176, 030178, 030179, 030180, 030181, 030185, 030186, 030191, 030192, 030537, 030538, 030540, 030541, 030544, 030545, 030546, 030548, 030549, 030551, 030552, 030554, 030556, 030557, 030559, 030561, 030562, 030563, 030567, 030569, 030571, 030573, 030575, 030576, 030577, 030578, 030580, 030581, 030582, 030583, 030584, 030586, 030607, 030609, 030611, 030612, 030613, 030614, 030615, 030616, 030617, 030621, 030623, 030624, 030628, 030629, 030631, 030632, 030633, 030634, 030635, 030640, 030641, 030642, 030643, 030646, 030648, 030649, 030650, 030651, 030653, 031017, 031020, 031021, 031022, 031024, 031026, 031027, 031028, 031029, 031031, 031032, 031034, 031036, 031042, 031044, 031046, 031051, 031053, 031055, 031057, 031060, 031061, 031063, 031064, 031066, 031067, 031075, 031077, 031079, 031084, 031085, 031087, 031091, 031092, 031095, 031096, 031097, 031098, 031099, 031100, 031230, 031231, 031232, 031236, 031237, 031239, 031240, 031241, 031245, 031246, 031247, 031250, 031251, 031252, 031253, 031254, 031255, 031256, 031257, 031258, 031283, 031285, 031286, 031287, 031288, 031289, 031290, 031292, 031293, 031294, 031316, 031317, 031319, 031507, 031508, 031511, 031512, 031513, 031514, 031517, 031518, 031519, 031521, 031522, 031523, 031524, 031525, 031526, 031527, 031528, 031529, 031530, 031533, 031534, 031535, 031536, 031537, 031538, 031539, 031541, 031543, 031544, 031546, 031548, 031549, 031550, 031595, 031596, 031597, 031598, 031600, 031601, 031602, 031603, 031606, 031607, 031608, 031609, 031651, 031652, 031655, 031661, 031665, 031666, 031669, 031926, 031927, 031928, 031930, 031932, 031934, 031936, 031937, 031940, 031943, 031944, 031945, 031946, 031949, 031950, 031953, 031954, 031961, 031962, 031965, 031966, 031969, 031970, 031972, 031973, 031974, 031975, 031976, 031977, 031979, 031980, 031981, 031982, 031983, 031986, 031989, 031990, 031991, 031992, 031996, 031997, 031998, 032000, 032001, 032002, 032004, 032006, 032007, 032008, 032010, 032014, 032015, 032016, 032017, 032018, 032019, 032022, 032024, 032177, 032178, 032180, 032183, 032184, 032186, 032187, 032191, 032193, 032194, 032196, 032200, 032204, 032205, 032207, 032208, 032209, 032210, 032211, 032212, 032213, 032215, 032216, 032217, 032220, 032222, 032223, 032225, 032226, 032229, 032391, 032392, 032393, 032394, 032398, 032399, 032400, 032401, 032402, 032404, 032407, 032408, 032409, 032410, 032412, 032413, 032415, 032416, 032417, 032418, 032444, 032446, 032447, 032448, 032449, 032453, 032454, 032455, 032456, 032458, 032459, 032461, 032463, 032473, 032476, 032479, 032480, 032481, 032522, 032524, 032525, 032527, 032529, 032530, 032532, 032533, 032534, 032535, 032537, 032538, 032541, 032575, 032576, 032577, 032579, 032580, 032581, 032584, 032585, 032586, 032587, 032590, 032591, 032595, 032596, 032598, 032599, 032600, 032601, 032602, 032624, 032625, 032627, 032628, 032815, 032816, 032820, 032823, 032825, 032826, 032828, 032829, 032830, 032832, 032833, 032848, 032854, 032855, 032856, 032857, 032859, 032860, 032861, 032863, 032865, 032966, 032969, 032970, 032971, 032972, 032973, 032974, 032977, 032979, 032980, 032981, 032982, 032983, 032984, 032987, 032991, 032995, 033022, 033043, 033046, 033048, 033049, 033051, 033052, 033053, 033057, 033058, 033059, 033060, 033064, 033068, 033069, 033072, 033073, 033074, 033078, 033079, 033080, 033081, 033082, 033355, 033356, 033357, 033358, 033359, 033360, 033361, 033362, 033363, 033364, 033365, 033367, 033372, 033373, 033374, 033375, 033377, 033378, 033379, 033380, 033382, 033384, 033467, 033468, 033470, 033472, 033491, 033492, 033497, 033498, 033499, 033501, 033502, 033503, 033504, 033508, 033823, 033826, 033827, 033831, 033832, 033835, 033836, 033839, 033840, 033841, 033863, 033864, 033865, 033867, 033869, 033870, 033871, 033872, 033873, 033874, 033876, 033877, 033878, 033879, 033881, 033884, 033886, 033889, 033890, 033891, 033892, 033893, 033894, 033895, 033896, 033897, 033898, 033899, 033900, 033902, 033903, 033904, 033908, 033909, 033910, 033912, 033914, 033917, 033918, 033920, 033922, 033923, 033924, 033925, 033927, 033931, 033932, 033933, 033934, 033935, 033937, 033938, 034043, 034044, 034045, 034046, 034047, 034050, 034051, 034113, 034116, 034117, 034118, 034119, 034120, 034121, 034127, 034130, 034131, 034175, 034177, 034178, 034179, 034180, 034181, 034182, 034183, 034184, 034186, 034208, 034211, 034212, 034213, 034214, 034216, 034217, 034418, 034420, 034421, 034422, 034424, 034425, 034429, 034431, 034433, 034434, 034436, 034437, 034440, 034441, 034442, 034443, 034444, 034446, 034448, 034449, 034453, 034454, 034456, 034457, 034898, 034899, 034901, 034902, 034904, 034907, 034932, 034935, 034936, 034937, 034939, 034941, 034942, 034943, 034944, 034945, 034948, 034949, 034950, 034951, 034955, 034957, 034959, 034960, 034961, 034964, 034965, 034966, 034967, 034968, 034970, 034971, 034972, 034973, 034975, 034976, 034998, 034999, 035004, 035007, 035008, 035012, 035015, 035016, 035294, 035297, 035302, 035303, 035328, 035330, 035332, 035333, 035334, 035336, 035337, 035338, 035339, 035340, 035342, 035343, 035344, 035345, 035347, 035350, 035351, 035353, 035356, 035357, 035358, 035360, 035361, 035362, 035366, 035367, 035368, 035369, 035371, 035375, 035377, 035398, 035399, 035400, 035401, 035402, 035405, 035406, 035408, 035410, 035411, 035412, 035413, 035414, 035415, 035416, 035460, 035462, 035463, 035464, 035470, 035472, 035474, 035476, 035477, 035498, 035503, 035505, 035506, 035512, 035513, 035514, 035515, 035516, 035517, 035518, 035519, 035520, 035521, 035526, 035527, 035629, 035632, 035635, 035637, 035659, 035662, 035664, 035665, 035708, 035710, 035711, 035712, 035714, 035718, 035719, 035720, 035723, 035724, 035726, 035728, 035729, 035731, 035733, 035734, 035735, 035737, 035738, 035739, 035742, 035743, 035744, 035745, 035746, 035750, 035751, 035752, 035753, 035754, 035778, 035783, 035784, 035785, 035786, 035787, 035789, 035790, 035795, 035828, 035829, 035832, 035837, 035838, 035841, 036081, 036082, 036083, 036084, 036086, 036088, 036089, 036090, 036092, 036095, 036096, 036097, 036099, 036102, 036103, 036127, 036128, 036133, 036134, 036135, 036136, 036138, 036139, 036141, 036142, 036143, 036144, 036168, 036169, 036170, 036174, 036195, 036196, 036198, 036199, 036201, 036202, 036203, 036204, 036225, 036228, 036230, 036231, 036233, 036236, 036239, 036240, 036241, 036242, 036243, 036442, 036443, 036445, 036447, 036451, 036453, 036457, 036458, 036459, 036460, 036603, 036604, 036606, 036607, 036609, 036611, 036615, 036636, 036637, 036638, 036640, 036641, 036644, 036645, 036646, 036647, 036649, 036652, 036653, 036654, 036716, 036718, 036719, 036720, 036721, 036722, 036723, 036724, 036725, 036727, 036728, 036731, 036732, 036734, 036738, 036741, 036742, 036744, 036745, 036746, 036748, 036749, 036750, 036751, 036752, 036755, 036756, 036760, 036762, 036763, 036765, 036767, 036768, 036769, 036770, 036771, 036772, 036777, 036779, 036780, 036784, 036786, 036787, 036788, 036789, 036790, 036792, 036793, 036794, 036796, 036797, 036798, 036799, 036802, 036803, 036805, 036806, 036807, 036808, 036809, 036811, 036812, 036814, 036815, 036817, 036818, 036819, 036820, 036824, 036826, 036827, 036828, 036830, 036831, 036832, 036834, 036836, 036838, 036839, 036841, 036842, 036844, 036845, 036847, 036849, 036850, 036851, 036852, 036854, 036857, 036860, 036861, 036862, 036863, 036867, 036868, 036870, 036873, 036874, 036876, 036879, 036880, 036882, 036883, 036884, 036886, 036887, 036888, 036890, 036891, 036893, 036894, 036895, 036897, 036899, 036901, 036902, 036903, 036907, 036908, 036909, 036910, 036914, 036915, 036920, 036922, 036923, 036924, 036927, 036928, 036929, 036930, 036931, 036937, 036938, 036941, 036943, 036947, 036948, 036949, 036952, 036953, 036954, 036956, 036957, 036958, 036961, 036962, 036964, 036965, 036966, 036967, 036968, 036969, 036970, 036972, 036973, 036974, 036975, 036976, 036977, 036978, 036981, 036982, 036983, 036985, 036987, 036989, 036990, 036991, 036995, 036996, 036997, 036998, 036999, 037000, 037001, 037002, 037003, 037004, 037005, 037006, 037008, 037009, 037012, 037013, 037014, 037016, 037017, 037018, 037021, 037023, 037025, 037171, 037172, 037174, 037175, 037178, 037179, 037180, 037181, 037182, 037183, 037185, 037187, 037191, 037192, 037193, 037196, 037197, 037198, 037200, 037221, 037222, 037223, 037225, 037227, 037228, 037229, 037230, 037271, 037272, 037273, 037274, 037279, 037280, 037281, 037283, 037284, 037285, 037286, 037288, 037290, 037293, 037297, 037298, 037299, 037300, 037325, 037326, 037327, 037328, 037329, 037330, 037353, 037354, 037355, 037356, 037358, 037359, 037360, 037361, 037362, 037364, 037373, 037374, 037375, 037380, 037422, 037428, 037429, 037887, 037889, 037891, 037979, 037981, 037982, 037983, 037984, 037985, 037986, 037991, 037992, 037993, 037994, 037995, 037997, 037998, 038000, 038001, 038007, 038009, 038010, 038011, 038012, 038014, 038015, 038016, 038017, 038018, 038019, 038023, 038026, 038029, 038030, 038047, 038048, 038049, 038051, 038052, 038056, 038057, 038058, 038059, 038061, 038062, 038064, 038066, 038067, 038073, 038074, 038076, 038077, 038078, 038080, 038081, 038082, 038084, 038086, 038089, 038090, 038096, 038097, 038098, 038099, 038100, 038101, 038103, 038105, 038106, 038107, 038108, 038109, 038110, 038112, 038114, 038115, 038116, 038138, 038139, 038140, 038142, 038144, 038147, 038148, 038149, 038150, 038151, 038153, 038155, 038157, 038158, 038161, 038164, 038165, 038166, 038407, 038408, 038411, 038412, 038413, 038415, 038416, 038423, 038424, 038425, 038426, 038427, 038428, 038429, 038632, 038633, 038634, 038643, 038644, 038645, 038646, 038647, 038648, 038650, 038651, 038653, 038654, 038656, 038659, 038660, 038661, 038662, 038663, 038665, 038666, 038667, 038669, 038673, 038674, 038676, 038677, 038678, 038679, 038681, 038686, 038687, 038689, 038690, 038692, 038694, 038695, 038712, 038713, 038715, 038718, 038719, 038720, 038721, 039210, 039212, 039214, 039215, 039216, 039218, 039220, 039221, 039222, 039223, 039224, 039226, 039227, 039228, 039229, 039230, 039231, 039232, 039234, 039235, 039236, 039237, 039240, 039242, 039244, 039245, 039246, 039249, 039250, 039251, 039252, 039255, 039301, 039303, 039304, 039305, 039307, 039309, 039366, 039368, 039370, 039373, 039374, 039377, 039380, 039381, 039382, 039383, 039384, 039385, 039386, 039387, 039388, 039389, 039390, 039391, 039393, 039396, 039397, 039398, 039399, 039400, 039401, 039403, 039404, 039405, 039406, 039407, 039408, 039409, 039410, 039412, 039413, 039414, 039415, 039416, 039420, 039423, 039424, 039612, 039614, 039615, 039619, 039621, 039622, 039623, 039624, 039625, 039626, 039627, 039628, 039630, 039633, 039634, 039635, 039637, 039638, 039639, 039640, 039643, 039644, 039649, 039651, 039653, 039654, 039655, 039656, 039657, 039658, 039660, 039662, 039663, 039664, 039665, 039671, 039672, 039673, 039674, 039695, 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• 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: The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
• FDA Determined Cause: Component design/selection
• Action: An Important Medical Device Information letter dated August 2013 was sent to implanting and following physicians. The letter provided a description of the issue, describes clinical implications, provides the rate of occurrence, and gives recommendations for monitoring patients.
• Quantity in Commerce: 38,500 total worldwide
• Distribution: Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and 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.