Class 2 Device Recall Boston Scientific TELIGEN ICD

• Date Initiated by Firm: August 29, 2013
• Date Posted: October 17, 2013
• Recall Status: Terminated on April 10, 2014
• Recall Number: Z-0026-2014
• Recall Event ID: 66171
• PMA Number: P960040S155
• Product Classification: Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
• Product: Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. 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 E102, Serial Numbers: 000138, 000139, 000140, 000142, 000145, 000146, 000147, 000151, 000152, 000153, 000154, 000161, 000162, 000163, 000166, 000167, 000169, 000170, 000172, 000173, 000174, 000175, 000176, 000177, 000178, 000182, 000183, 000184, 000185, 000187, 000188, 000191, 000192, 000193, 000194, 000196, 000199, 000200, 000202, 000203, 000204, 000207, 000209, 000210, 000213, 000214, 000215, 000216, 000218, 000219, 000220, 000221, 000222, 000224, 000226, 000227, 000228, 000229, 000230, 000232, 000234, 000235, 000236, 000240, 000241, 000244, 000247, 000248, 000249, 000251, 000252, 000254, 000256, 000258, 000260, 000262, 000263, 000265, 000266, 000268, 000269, 000270, 000271, 000272, 000273, 000274, 000275, 000276, 000277, 000278, 000282, 000284, 000287, 000288, 000289, 000290, 000292, 000294, 000295, 000297, 000299, 000300, 000302, 000304, 000306, 000307, 000309, 000310, 000311, 000314, 000316, 000321, 000322, 000323, 000324, 000325, 000330, 000332, 000334, 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250683, 250684, 250685, 250689, 250692, 250693, 250694, 250696, 250697, 250698, 250702, 250703, 250704, 250705, 250707, 250708, 250709, 250711, 250712, 250713, 250714, 250715, 250716, 250719, 250720, 250721, 250723, 250725, 250727, 250728, 250730, 250731, 250732, 250734, 250736, 250738, 250739, 250760, 250762, 250763, 250765, 250766, 250767, 250768, 250771, 250772, 250773, 250775, 250776, 250777, 250778, 250780, 250781, 250782, 250784, 250785, 250788, 250789, 250790, 250791, 250792, 250793, 250794, 250796, 250797, 250798, 250799, 250800, 250801, 250802, 250804, 250805, 250807, 250808, 250810, 250815, 250816, 250817, 250818, 250819, 250820, 250821, 250824, 250825, 250826, 250828, 250829, 250830, 250831, 250832, 250835, 250836, 250837, 250838, 250839, 250840, 250842, 250843, 250845, 250846, 250847, 250848, 250849, 250851, 250852, 250853, 250854, 250855, 250856, 250857, 250859, 250860, 250861, 250863, 250865, 250867, 250868, 250869, 250871, 250872, 250873, 250874, 250875, 250876, 250877, 250879, 250881, 250882, 250883, 250885, 250886, 250887, 250888, 250889, 250890, 250891, 250892, 250893, 250894, 250896, 250897, 250898, 250900, 250901, 250902, 250903, 250905, 250906, 250909, 250910, 250911, 250912, 250913, 250915, 250917, 250919, 250922, 250923, 250924, 250925, 250926, 250927, 250928, 250929, 250931, 250933, 250938, 250944, 250945, 250946, 250947, 250950, 250952, 250953, 250966, 250972, 250974, 250975, 250976, 250981, 250985, 250986, 250988, 250990, 250993, 250998, 250999, 251002, 251009, 251011, 251012, 251015, 251017, 251020, 251022, 251023, 251026, 251028, 251031, 251035, 251039, 251042, 251046, 251051, 251052, 251053, 251054, 251055, 251056, 251059, 251061, 251063, 251067, 251069, 251075, 251078, 251081, 251086, 251087, 251093, 251101, 251102, 251103, 251106, 251110, 251112, 251115, 251117, 251120, 251123, 251128, 251129, 251131, 251132, 251135, 251137, 251138, 251139, 251140, 251143, 251144, 251145, 251148, 251149, 251150, 251153, 251155, 251158, 251159, 251163, 251168, 251175, 251196, 251202, 251203, 251205, 251208, 251217, 251220, 251221, 251226, 251229, 251235, 251237, 251238, 251242, 251245, 251253, 251254, 251262, 251266, 251270, 251274, 251275, 251287, 251293, 251301, 251303, 251307, 251325, 251331, 251333, 251334, 251339, 251344, 251361, 251362, 251370, 251381, 251389, 251391, 251398, 251399, 251402, 251404, 251405, 251407, 251408, 251411, 251414, 251419, 251425, 251430, 251435, 251436, 251440, 251441, 251444, 251450, 251454, 251463, 251468, 251472, 251474, 251502, 251505, 251514, 251537, 251538, 251549. Model E110, Serial Numbers: 000015, 000018, 000019, 000022, 000023, 000025, 000026, 000027, 000030, 000031, 000035, 000036, 000038, 000040, 000042, 000044, 000046, 000047, 000049, 000050, 000051, 000053, 000054, 000056, 000057, 000060, 000062, 000065, 000067, 000068, 000070, 000072, 000073, 000074, 000075, 000077, 000084, 000085, 000086, 000087, 000088, 000094, 000095, 000097, 000099, 000100, 000101, 000103, 000104, 000105, 000106, 000107, 000108, 000112, 000113, 000115, 000116, 000117, 000118, 000119, 000120, 000122, 000123, 000128, 000129, 000130, 000131, 000133, 000136, 000138, 000139, 000141, 000145, 000146, 000147, 000150, 000151, 000154, 000155, 000157, 000158, 000159, 000161, 000164, 000167, 000170, 000171, 000172, 000174, 000176, 000177, 000178, 000179, 000181, 000183, 000185, 000186, 000190, 000191, 000193, 000194, 000195, 000198, 000199, 000200, 000201, 000204, 000207, 000212, 000213, 000215, 000216, 000217, 000219, 000221, 000224, 000225, 000226, 000228, 000229, 000230, 000232, 000233, 000234, 000235, 000236, 000238, 000239, 000240, 000241, 000245, 000248, 000257, 000258, 000261, 000262, 000263, 000265, 000266, 000268, 000269, 000270, 000272, 000274, 000275, 000276, 000278, 000280, 000282, 000283, 000286, 000288, 000290, 000291, 000292, 000297, 000298, 000301, 000302, 000303, 000306, 000308, 000309, 000310, 000311, 000312, 000314, 000318, 000320, 000321, 000323, 000324, 000326, 000327, 000328, 000329, 000330, 000334, 000335, 000336, 000337, 000339, 000343, 000344, 000347, 000350, 000351, 000353, 000354, 000355, 000358, 000363, 000367, 000368, 000369, 000370, 000371, 000372, 000374, 000376, 000377, 000378, 000379, 000380, 000381, 000382, 000383, 000384, 000385, 000387, 000389, 000391, 000393, 000394, 000396, 000400, 000402, 000403, 000404, 000405, 000407, 000409, 000410, 000411, 000412, 000413, 000414, 000415, 000417, 000418, 000421, 000423, 000425, 000426, 000427, 000429, 000431, 000432, 000433, 000436, 000437, 000439, 000441, 000442, 000443, 000444, 000446, 000448, 000449, 000450, 000451, 000454, 000456, 000460, 000461, 000462, 000463, 000464, 000465, 000466, 000469, 000472, 000473, 000474, 000475, 000476, 000479, 000480, 000483, 000484, 000485, 000486, 000489, 000491, 000492, 000495, 000497, 000498, 000499, 000500, 000501, 000502, 000503, 000504, 000709, 000710, 000711, 000712, 000713, 000715, 000716, 000717, 000718, 000719, 000720, 000721, 000723, 000724, 000726, 000727, 000730, 000733, 000734, 000735, 000737, 000738, 000740, 000741, 000743, 000744, 000745, 000747, 000750, 000752, 000753, 000754, 000755, 000756, 000758, 000759, 000760, 000762, 000763, 000765, 000774, 000775, 000776, 000777, 000778, 000779, 000780, 000781, 000782, 000784, 000785, 000786, 000787, 000788, 000796, 000797, 000843, 000844, 000856, 000857, 000859, 000862, 000864, 000866, 000867, 000868, 000869, 000870, 000871, 000872, 000875, 000876, 000877, 000878, 000880, 000884, 000885, 000886, 000888, 000889, 000891, 000893, 000894, 000895, 000896, 000898, 000899, 000900, 000901, 000902, 000904, 000908, 000910, 000911, 000912, 000913, 000914, 000917, 000918, 000919, 000920, 000921, 000923, 000926, 000929, 000930, 000931, 000932, 000933, 000934, 000935, 000936, 000937, 000938, 000939, 000940, 000941, 000942, 000943, 000944, 000946, 000948, 000954, 000955, 000956, 000958, 000959, 000961, 000962, 000964, 000965, 000966, 000967, 000969, 000971, 000973, 000974, 000975, 001008, 001009, 001010, 001011, 001012, 001013, 001014, 001015, 001017, 001018, 001019, 001022, 001023, 001025, 001026, 001029, 001030, 001032, 001033, 001034, 001035, 001036, 001039, 001041, 001042, 001043, 001044, 001046, 001047, 001048, 001049, 001050, 001052, 001053, 001054, 001055, 001056, 001057, 001060, 001061, 001062, 001068, 001069, 001141, 001142, 001143, 001144, 001146, 001148, 001149, 001153, 001154, 001155, 001157, 001159, 001160, 001163, 001164, 001165, 001166, 001167, 001169, 001172, 001174, 001175, 001176, 001178, 001179, 001180, 001181, 001182, 001183, 001184, 001185, 001186, 001187, 001188, 001191, 001193, 001195, 001196, 001197, 001199, 001200, 001203, 001204, 001208, 001209, 001210, 001223, 001224, 001226, 001228, 001229, 001234, 001235, 001237, 001238, 001240, 001241, 001244, 001246, 001247, 001248, 001252, 001253, 001254, 001255, 001261, 001262, 001263, 001264, 001265, 011176, 011193, 011290, 011291, 011292, 011293, 011294, 011295, 011296, 011297, 011298, 011299, 011300, 011302, 011308, 011310, 011311, 011312, 011313, 011315, 011316, 011318, 011320, 011321, 011322, 011323, 011324, 011328, 011329, 011331, 011332, 011335, 011336, 011337, 011340, 011341, 011344, 011346, 011347, 011348, 011350, 011351, 011352, 011353, 011356, 011357, 011358, 011359, 011363, 011364, 011365, 011367, 011368, 011369, 011372, 011373, 011375, 011377, 011378, 011379, 011380, 011382, 011383, 011384, 011386, 011387, 011389, 011391, 011392, 011395, 011397, 011398, 011399, 011400, 011401, 011402, 011403, 011404, 011406, 011408, 011411, 011413, 011414, 011417, 011418, 011420, 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011644, 011647, 011648, 011649, 011650, 011651, 011652, 011653, 011657, 011658, 011659, 011660, 011661, 011662, 011663, 011665, 011668, 011672, 011673, 011674, 011675, 011677, 011679, 011683, 011685, 011687, 011688, 011689, 011691, 011692, 011694, 011695, 011696, 011697, 011698, 011699, 011700, 011701, 011703, 011705, 011706, 011708, 011709, 011710, 011713, 011714, 011715, 011716, 011717, 011718, 011719, 011720, 011721, 011722, 011723, 011724, 011725, 011726, 011727, 011728, 011729, 011731, 011732, 011733, 011735, 011736, 011738, 011739, 011740, 011742, 011743, 011744, 011747, 011748, 011750, 011751, 011753, 011754, 011755, 011758, 011759, 011760, 011761, 011764, 011766, 011767, 011768, 011769, 011770, 011771, 011772, 011773, 011774, 011775, 011780, 011781, 011782, 011783, 011785, 011786, 011787, 011789, 011791, 011792, 011795, 011796, 011797, 011799, 011801, 011802, 011803, 011806, 011807, 011808, 011809, 011813, 011814, 011817, 011818, 011820, 011821, 011822, 011823, 011824, 011825, 011826, 011827, 011828, 011829, 011830, 011831, 011832, 011837, 011840, 011842, 011843, 011845, 011846, 011847, 011849, 011850, 011851, 011853, 011854, 011856, 011857, 011859, 011860, 011861, 011863, 011865, 011866, 011867, 011868, 011869, 011871, 011872, 011873, 011874, 011875, 011878, 011879, 011880, 011881, 011882, 011883, 011884, 011885, 011886, 011887, 011891, 011893, 011894, 011896, 011897, 011899, 011900, 011903, 011904, 011906, 011907, 011908, 011909, 011911, 011912, 011914, 011916, 011917, 011918, 011919, 011920, 011921, 011923, 011924, 011926, 011927, 011930, 011932, 011934, 011935, 011936, 011937, 011938, 011939, 011941, 011942, 011944, 011945, 011948, 011949, 011950, 011953, 011954, 011955, 011956, 011957, 011959, 011960, 011961, 011962, 011964, 011968, 011969, 011972, 011974, 011975, 011976, 011979, 011980, 011982, 011983, 011984, 011985, 011986, 011988, 011989, 011990, 011991, 011995, 011997, 012000, 012002, 012003, 012006, 012007, 012011, 012014, 012016, 012017, 012018, 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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.

• PMA Database: PMAs with Product Code = LWP and Original Applicant = BOSTON SCIENTIFIC