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U.S. Department of Health and Human Services

Class 2 Device Recall CONTAK RENEWAL 4

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 Class 2 Recall
CONTAK RENEWAL 4
see related information
Date Posted July 11, 2007
Recall Status1 Terminated on March 02, 2008
Recall Number Z-1048-2007
Recall Event ID 37769
Premarket Approval
PMA Number
P960040
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product These models are not available in the US. CONTAK RENEWAL 4 (model H190, H195). CONTAK RENEWAL 4 HE (model H197, H199) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Code Information Model H190, serial numbers: 300805, 300809, 300810, 300812, 300813, 300814, 300815, 300816, 300818, 300819, 300820, 300821, 300822, 300823, 300824, 300826, 300827, 300833, 300834, 300837, 300838, 300840, 300841, 300842, 300843, 300844, 300846, 300847, 300848, 300849, 300852, 300853, 300855, 300858, 300859, 300860, 300861, 300862, 300864, 300865, 300866, 300867, 300868, 300871, 300872, 300873, 300874, 300875, 300876, 300877, 300878, 300879, 300880, 300882, 300883, 300886, 300887, 300893, 300894, 300895, 300896, 300897, 300911, 300912, 300913, 300915, 300916, 300917, 300918, 300919, 300970, 300971, 301000, 301066, 301068, 301071, 301072, 301073, 301075, 301076, 301077, 301078, 301080, 301083, 301084, 301088, 301095, 301097, 301098, 301099, 301101, 301105, 301122, 301125, 301126, 301129, 301130, 301135, 301136, 301137, 301139, 301149, 301155, 301158, 301159, 301163, 301164, 301166, 301169, 301170, 301174, 301175, 301176, 301180, 301182, 301183, 301185, 301186, 301194, 301218, 301220, 301222, 301226, 301231, 301232, 301233, 301235, 301236, 301238, 301239, 301240, 301242, 301243, 301245, 301246, 301250, 301254, 301256, 301257, 301258, 301263, 301265, 301266, 301269, 301270, 301272, 301281, 301289, 301295, 301298, 301299, 301302, 301304, 301306, 301307, 301310, 301314, 301315, 301322, 301323, 301324, 301332, 301347, 301349, 301357, 301360, 301363, 301364, 301383, 301392, 301400, 301406, 301407, 301423, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310235, 310238, 310239, 310240, 310241, 310242, 310243, 310244, 310245, 310246, 310247, 310248, 310249, 310250, 310251, 310252, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310267, 310268, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310281, 310282, 310283, 310284, 310285, 310286, 310287, 310288, 310289, 310290, 310291, 310292, 310294, 310296, 310297, 310298, 310299, 310300, 310301, 310302, 310303, 310304, 310305, 310307, 310308, 310309, 310310, 310311, 310312, 310313, 310314, 310316, 310320, 310321, 310323, 310324, 310326, 310329, 310330, 310331, 310332, 310333, 310334, 310335, 310336, 310337, 310338, 310339, 310340, 310341, 310343, 310344, 310345, 310346, 310347, 310348, 310349, 310350, 310351, 310352, 310353, 310354, 310356, 310357, 310358, 310359, 310360, 310361, 310362, 310363, 310364, 310365, 310366, 310367, 310369, 310370, 310371, 310373, 310374, 310375, 310376, 310378, 310380, 310381, 310382, 310383, 310384, 310388, 310391, 310392, 310393, 310394, 310395, 310396, 310397, 310398, 310399, 310400, 310401, 310403, 310407, 310408, 310411, 310413, 310414, 310415, 310416, 310417, 310418, 310419, 310420, 310421, 310422, 310423, 310424, 310425, 310426, 310427, 310428, 310429, 310430, 310431, 310433, 310434, 310436, 310437, 310438, 310439, 310441, 310442, 310443, 310444, 310445, 310446, 310447, 310448, 310449, 310451, 310452, 310453, 310454, 310455, 310456, 310457, 310458, 310459, 310461, 310462, 310463, 310464, 310465, 310466, 310467, 310468, 310469, 310470, 310471, 310472, 310473, 310474, 310475, 310476, 310477, 310479, 310480, 310481, 310482, 310483, 310484, 310485, 310486, 310487, 310488, 310489, 310490, 310491, 310492, 310493, 310494, 310495, 310552, 310553, 310554, 310555, 310556, 310557, 310558, 310559, 310561, 310562, 310564, 310565, 310566, 310567, 310568, 310569, 310570, 310571, 310572, 310573, 310574, 310576, 310577, 310579, 310580, 310582, 310583, 310585, 310588, 310589, 310590, 310591, 310592, 310593, 310594, 310595, 310596, 310597, 310598, 310599, 310600, 310601, 310602, 310603, 310604, 310605, 310606, 310607, 310608, 310609, 310610, 310611, 310612, 310613, 310614, 310615, 310616, 310618, 310619, 310620, 310621, 310622, 310623, 310624, 310625, 310626, 310627, 310628, 310629, 310631, 310632, 310633, 310634, 310636, 310637, 310638, 310639, 310640, 310641, 310643, 310644, 310645, 310646, 310647, 310648, 310649, 310650, 310651, 310652, 310653, 310654, 310655, 310656, 310657, 310658, 310659, 310660, 310661, 310662, 310665, 310666, 310667, 310668, 310669, 310670, 310671, 310672, 310673, 310675, 310676, 310677, 310678, 310680, 310681, 310682, 310683, 310684, 310685, 310686, 310687, 310688, 310689, 310690, 310691, 310692, 310693, 310694, 310695, 310696, 310697, 310699, 310700, 310701, 310702, 310703, 310704, 310705, 310706, 310708, 310709, 310710, 310711, 310712, 310713, 310714, 310715, 310716, 310717, 310718, 310719, 310720, 310721, 310722, 310723, 310724, 310725, 310726, 310727, 310728, 310729, 310730, 310731, 310732, 310734, 310735, 310736, 310737, 310738, 310739, 310740, 310741, 310742, 310743, 310744, 310745, 310746, 310747, 310748, 310749, 310750, 310751, 310752, 310753, 310754, 310755, 310756, 310757, 310758, 310759, 310760, 310761, 310762, 310763, 310764, 310767, 310768, 310769, 310770, 310771, 310772, 310773, 310774, 310775, 310776, 310777, 310778, 310779, 310780, 310781, 310782, 310783, 310784, 310785, 310786, 310787, 310788, 310789, 310790, 310791, 310792, 310793, 310794, 310795, 310796, 310797, 310798, 310800, 310801, 310802, 310803, 310804, 310805, 310806, 310807, 310808, 310809, 310810, 310811, 310812, 310813, 310814, 310816, 310817, 310818, 310819, 310820, 310821, 310822, 310823, 310824, 310825, 310826, 310827, 310828, 310829, 310831, 310833, 310834, 310835, 310836, 310837, 310838, 310840, 310841, 310842, 310843, 310844, 310845, 310846, 310847, 310848, 310849, 310850, 310851, 310852, 310853, 310854, 310855, 310856, 310857, 310858, 310859, 310860, 310861, 310862, 310864, 310865, 310866, 310868, 310869, 310870, 310871, 310875, 310876, 310877, 310878, 310879, 310880, 310881, 310882, 310883, 310884, 310885, 310886, 310887, 310889, 310890, 310892, 310893, 310894, 310896, 310897, 310898, 310899, 310900, 310901, 310902, 310904, 310905, 310906, 310907, 310908, 310909, 310912, 310913, 310914, 310915, 310917, 310918, 310919, 310921, 310922, 310924, 310925, 310926, 310927, 310928, 310930, 310931, 310932, 310933, 310934, 310935, 310936, 310937, 310938, 310940, 310943, 310944, 310945, 310946, 310947, 310948, 310949, 310950, 310951, 310952, 310953, 310954, 310955, 310956, 310957, 310958, 310959, 310960, 310961, 310962, 310963, 310964, 310965, 310966, 310967, 310968, 310969, 310970, 310971, 310973, 310974, 310975, 310976, 310977, 310981, 310982, 310983, 310984, 310985, 310988, 310995, 310997, 311000, 311002, 311005, 311006, 311007, 311008, 311009, 311010, 311011, 311012, 311013, 311014, 311015, 311016, 311017, 311018, 311019, 311020, 311021, 311022, 311023, 311024, 311025, 311026, 311027, 311030, 311031, 311032, 311033, 311034, 311035, 311036, 311037, 311038, 311039, 311040, 311041, 311042, 311043, 311044, 311045, 311047, 311048, 311049, 311050, 311052, 311054, 311055, 311057, 311058, 311059, 311060, 311062, 311063, 311064, 311065, 311066, 311067, 311068, 311069, 311071, 311072, 311073, 311074, 311075, 311076, 311077, 311079, 311080, 311082, 311083, 311084, 311085, 311086, 311087, 311088, 311089, 311090, 311091, 311092, 311093, 311094, 311095, 311096, 311097, 311098, 311099, 311100, 311101, 311102, 311103, 311104, 311105, 311106, 311107, 311108, 311109, 311110, 311111, 311112, 311113, 311114, 311115, 311116, 311117, 311118, 311119, 311120, 311121, 311122, 311123, 311124, 311125, 311126, 311127, 311128, 311130, 311131, 311136, 311137, 311138, 311140, 311141, 311142, 311143, 311144, 311145, 311146, 311147, 311148, 311149, 311150, 311151, 311152, 311153, 311154, 311155, 311157, 311158, 311159, 311160, 311161, 311162, 311163, 311164, 311165, 311166, 311167, 311168, 311169, 311170, 311171, 311172, 311173, 311174, 311175, 311176, 311177, 311178, 311179, 311180, 311181, 311182, 311183, 311184, 311185, 311186, 311189, 311190, 311191, 311192, 311193, 311194, 311195, 311196, 311197, 311198, 311199, 311200, 311201, 311202, 311203, 311204, 311205, 311206, 311208, 311210, 311211, 311212, 311215, 311216, 311217, 311218, 311219, 311220, 311221, 311222, 311223, 311224, 311225, 311226, 311227, 311228, 311229, 311230, 311231, 311232, 311233, 311234, 311235, 311236, 311237, 311239, 311241, 311243, 311244, 311245, 311246, 311247, 311248, 311249, 311250, 311251, 311252, 311253, 311254, 311255, 311257, 311258, 311259, 311260, 311261, 311262, 311263, 311264, 311265, 311266, 311268, 311269, 311271, 311273, 311274, 311275, 311276, 311277, 311278, 311279, 311280, 311281, 311283, 311284, 311286, 311287, 311288, 311289, 311290, 311291, 311292, 311293, 311294, 311295, 311296, 311297, 311298, 311299, 311301, 311302, 311303, 311304, 311305, 311306, 311307, 311308, 311309, 311310, 311312, 311313, 311314, 311317, 311318, 311319, 311320, 311322, 311323, 311324, 311325, 311326, 311327, 311328, 311329, 311330, 311332, 311334, 311335, 311336, 311337, 311338, 311340, 311341, 311342, 311343, 311344, 311346, 311347, 311348, 311349, 311350, 311351, 311352, 311353, 311354, 311355, 311356, 311357, 311359, 311361, 311362, 311363, 311365, 311366, 311367, 311368, 311369, 311370, 311371, 311372, 311373, 311374, 311375, 311376, 311377, 311378, 311379, 311381, 311382, 311384, 311385, 311386, 311387, 311389, 311390, 311393, 311394, 311395, 311396, 311397, 311398, 311402, 311404, 311405, 311407, 311408, 311411, 311412, 311413, 311414, 311416, 311417, 311418, 311420, 311422, 311424, 311425, 311427, 311429, 311430, 311433, 311434, 311435, 311436, 311437, 311438, 311439, 311440, 311442, 311443, 311444, 311445, 311446, 311447, 311448, 311449, 311450, 311451, 311452, 311453, 311454, 311455, 311456, 311457, 311459, 311460, 311461, 311462, 311463, 311467, 311468, 311470, 311472, 311528, 311529, 311530, 311531, 311532, 311536, 311538, 311540, 311541, 311542, 311543, 311544, 311545, 311546, 311547, 311548, 311549, 311550, 311553, 311554, 311555, 311556, 311558, 311559, 311560, 311561, 311563, 311564, 311565, 311566, 311567, 311568, 311570, 311571, 311575, 311576, 311578, 311580, 311581, 311583, 311584, 311586, 311587, 311588, 311590, 311593, 311594, 311595, 311596, 311597, 311599, 311600, 311602, 311604, 311605, 311606, 311607, 311608, 311609, 311610, 311611, 311612, 311614, 311615, 311616, 311618, 311619, 311620, 311621, 311623, 311624, 311625, 311626, 311627, 311628, 311630, 311631, 311632, 311633, 311634, 311635, 311636, 311637, 311638, 311639, 311641, 311642, 311643, 311644, 311645, 311646, 311650, 311651, 311653, 311655, 311659, 311660, 311661, 311662, 311665, 311667, 311668, 311671, 311673, 311675, 311676, 311677, 311678, 311679, 311681, 311682, 311684, 311685, 311686, 311688, 311690, 311691, 311692, 311693, 311697, 311698, 311699, 311701, 311702, 311703, 311704, 311705, 311706, 311707, 311708, 311709, 311710, 311711, 311712, 311713, 311717, 311718, 311720, 311723, 311725, 311727, 311728, 311729, 311730, 311731, 311738, 311749, 311750, 311753, 311754, 311756, 311760, 311761, 311762, 311765, 311767, 311768, 311770, 311772, 311773, 311774, 311775, 311776, 311777, 311778, 311779, 311780, 311786, 311792, 311793, 311794, 311798, 311800, 311804, 311806, 311809, 311812, 311817, 311819, 311820, 311822, 311829, 311830, 311831, 311839, 311841, 311842, 311844, 311846, 311847, 311848, 311849, 311851, 311859, 311860, 311861, 311862, 311863, 311865, 311866, 311867, 311868, 311869, 311870, 311872, 311873, 311874, 311875, 311876, 311877, 311878, 311879, 311880, 311881, 311882, 311883, 311885, 311886, 311887, 311888, 311889, 311890, 311891, 311892, 311895, 311896, 311897, 311899, 311905, 311906, 311908, 311909, 311911, 311912, 311917, 311920, 311925, 311926, 311927, 311930, 311931, 311932, 311936, 311937, 311942, 311943, 311944, 311945, 311946, 311947, 311948, 311949, 311950, 311951, 311952, 311953, 311954, 311955, 311957, 311958, 311964, 311966, 311968, 311969, 311972, 311973, 311975, 311980, 311982, 311985, 311987, 311990, 311991, 311992, 311993, 311994, 311995, 311997, 311998, 311999, 312000, 312002, 312007, 312008, 312009, 312010, 312013, 312015, 312017, 312018, 312020, 312021, 312022, 312024, 312034, 312036, 312041, 312043, 312044, 312052, 312053, 312054, 312055, 312057, 312058, 312059, 312060, 312061, 312063, 312064, 312066, 312067, 312069, 312070, 312071, 312072, 312073, 312074, 312075, 312076, 312078, 312079, 312080, 312081, 312082, 312083, 312084, 312085, 312086, 312087, 312088, 312089, 312090, 312091, 312092, 312094, 312095, 312096, 312097, 312098, 312099, 312100, 312102, 312103, 312104, 312105, 312106, 312107, 312108, 312109, 312111, 312112, 312114, 312115, 312116, 312117, 312118, 312119, 312120, 312121, 312122, 312123, 312124, 312126, 312127, 312128, 312129, 312130, 312131, 312132, 312133, 312134, 312135, 312139, 312140, 312146, 312147, 312148, 312149, 312150, 312155, 312156, 312158, 312160, 312161, 312162, 312163, 312165, 312170, 312172, 312173, 312174, 312175, 312176, 312178, 312179, 312181, 312182, 312183, 312184, 312185, 312186, 312187, 312188, 312192, 312193, 312195, 312198, 312199, 312200, 312201, 312202, 312203, 312204, 312205, 312206, 312208, 312209, 312210, 312212, 312220, 312222, 312223, 312224, 312225, 312237, 312238, 312243, 312246, 312267, 312270, 312299, 312300, 312318, 312319, 312346, 312349, 312399, 312436, 312438, 312440, 312441, 312442, 312443, 312444, 312445, 312446, 312449, 312450, 312451, 312452, 312454, 312455, 312529, 312530, 312531, 312534, 312536, 312539, 312540, 312541, 312542, 312543, 312813, 312827, 312828, 312829, 312841, 312850, 312872. Model H195, serial numbers: 305157, 305158, 305160, 305161, 305164, 305165, 305166, 305167, 305169, 305179, 305190, 305192, 305193, 305194, 305195, 305197, 305202, 305203, 305204, 305205, 305206, 305207, 305208, 305209, 305211, 305212, 305213, 305214, 305215, 305218, 305220, 305221, 305226, 305227, 305228, 305229, 305230, 305231, 305232, 305233, 305234, 305238, 305239, 305240, 305241, 305243, 305244, 305246, 305247, 305248, 305251, 305252, 305253, 305254, 305255, 305257, 305258, 305259, 305260, 305263, 305264, 305265, 305267, 305268, 305270, 305271, 305274, 305275, 305276, 305277, 305278, 305279, 305280, 305281, 305282, 305283, 305284, 305285, 305286, 305288, 305289, 305291, 305292, 305293, 305295, 305297, 305298, 305299, 305300, 305301, 305302, 305303, 305305, 305307, 305308, 305309, 305310, 305311, 305312, 305313, 305314, 305315, 305316, 305320, 305321, 305322, 305323, 305324, 305325, 305326, 305328, 305330, 305331, 305332, 305333, 305334, 305335, 305336, 305337, 305338, 305339, 305340, 305341, 305342, 305343, 305344, 305345, 305346, 305347, 305348, 305351, 305352, 305353, 305354, 305355, 305357, 305358, 305359, 305360, 305361, 305362, 305364, 305365, 305366, 305367, 305370, 305371, 305372, 305373, 305374, 305377, 305378, 305379, 305380, 305382, 305384, 305385, 305387, 305392, 305394, 305395, 305397, 305398, 305399, 305400, 305401, 305403, 305406, 305407, 305408, 305409, 305410, 305411, 305412, 305413, 305414, 305416, 305417, 305418, 305419, 305420, 305421, 305423, 305424, 305428, 305434, 305435, 305436, 305437, 305443, 305452, 305454, 305455, 305456, 305460, 305461, 305463, 305464, 305465, 305466, 305467, 305468, 305470, 305471, 305472, 305473, 305474, 305475, 305476, 305478, 305479, 305482, 305483, 305487, 305488, 305489, 305490, 305491, 305492, 305494, 305495, 305496, 305497, 305498, 305499, 305500, 305501, 305502, 305506, 305508, 305509, 305510, 305511, 305512, 305514, 305516, 305517, 305518, 305519, 305520, 305521, 305522, 305523, 305524, 305526, 305528, 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352456, 352457, 352459, 352460, 352461, 352462, 352463, 352464, 352465, 352468, 352469, 352471, 352472, 352473, 352475, 352476, 352477, 352478, 352480, 352481, 352482, 352483, 352484, 352485, 352489, 352490, 352491, 352492, 352493, 352494, 352496, 352497, 352498, 352499, 352500, 352501, 352503, 352505, 352507, 352508, 352511, 352513, 352514, 352516, 352517, 352518, 352519, 352520, 352521, 352522, 352523, 352524, 352525, 352526, 352527, 352528, 352529, 352530, 352531, 352532, 352533, 352534, 352535, 352536, 352537, 352538, 352539, 352540, 352541, 352542, 352543, 352545, 352546, 352547, 352548, 352549, 352550, 352551, 352552, 352553, 352554, 352555, 352556, 352557, 352558, 352559, 352560, 352561, 352562, 352563, 352564, 352565, 352566, 352567, 352568, 352569, 352570, 352571, 352572, 352573, 352574, 352575, 352576, 352577, 352578, 352579, 352580, 352582, 352583, 352585, 352586, 352587, 352588, 352589, 352590, 352591, 352593, 352594, 352595, 352596, 352597, 352598, 352599, 352600, 352601, 352603, 352604, 352605, 352606, 352607, 352609, 352610, 352611, 352612, 352616, 352617, 352618, 352619, 352620, 352622, 352623, 352624, 352625, 352626, 352627, 352628, 352629, 352630, 352631, 352632, 352634, 352635, 352636, 352638, 352639, 352640, 352641, 352643, 352644, 352646, 352647, 352648, 352649, 352650, 352651, 352652, 352653, 352654, 352655, 352656, 352658, 352659, 352660, 352662, 352663, 352664, 352665, 352666, 352667, 352668, 352669, 352670, 352671, 352672, 352673, 352674, 352675, 352676, 352677, 352679, 352680, 352681, 352682, 352685, 352686, 352687, 352688, 352689, 352690, 352692, 352694, 352696, 352697, 352698, 352700, 352702, 352704, 352707, 352709, 352711, 352712, 352713, 352716, 352717, 352719, 352720, 352723, 352725, 352727, 352728, 352729, 352731, 352732, 352733, 352735, 352736, 352738, 352740, 352741, 352742, 352744, 352745, 352746, 352748, 352749, 352751, 352752, 352755, 352756, 352758, 352759, 352760, 352761, 352762, 352763, 352764, 352765, 352766, 352767, 352768, 352769, 352770, 352771, 352772, 352773, 352774, 352777, 352778, 352779, 352780, 352781, 352782, 352783, 352785, 352786, 352787, 352788, 352789, 352790, 352791, 352793, 352794, 352795, 352796, 352797, 352798, 352799, 352800, 352801, 352802, 352803, 352804, 352805, 352806, 352807, 352808, 352809, 352810, 352811, 352812, 352813, 352814, 352815, 352816, 352817, 352818, 352819, 352820, 352821, 352822, 352823, 352824, 352825, 352826, 352827, 352828, 352829, 352830, 352831, 352832, 352833, 352834, 352835, 352836, 352837, 352838, 352840, 352841, 352842, 352843, 352844, 352845, 352846, 352847, 352848, 352850, 352851, 352852, 352854, 352856, 352857, 352858, 352860, 352861, 352862, 352863, 352864, 352866, 352867, 352868, 352871, 352876, 352881, 352886, 352888, 352890, 352891, 352892, 352893, 352894, 352895, 352897, 352898, 352900, 352903, 352905, 352906, 352907, 352908, 352909, 352910, 352912, 352913, 352916, 352917, 352918, 352919, 352920, 352921, 352922, 352923, 352924, 352925, 352926, 352927, 352928, 352929, 352930, 352931, 352932, 352933, 352934, 352935, 352936, 352938, 352940, 352941, 352942, 352943, 352944, 352945, 352946, 352948, 352949, 352950, 352951, 352953, 352954, 352955, 352956, 352957, 352958, 352959, 352960, 352962, 352963, 352965, 352966, 352967, 352970, 352972, 352973, 352974, 352976, 352977, 352978, 352979, 352980, 352981, 352983, 352984, 352985, 352986, 352987, 352988, 352989, 352990, 352991, 352992, 352993, 352994, 352995, 352996, 352997, 352998, 352999, 353000, 353001, 353002, 353003, 353004, 353005, 353006, 353007, 353008, 353010, 353011, 353012, 353013, 353014, 353015, 353016, 353017, 353018, 353019, 353020, 353021, 353022, 353023, 353025, 353027, 353028, 353029, 353031, 353032, 353033, 353034, 353035, 353036, 353037, 353039, 353040, 353042, 353045, 353046, 353047, 353048, 353050, 353052, 353053, 353054, 353056, 353058, 353059, 353060, 353063, 353064, 353065, 353066, 353067, 353068, 353069, 353071, 353072, 353073, 353074, 353075, 353076, 353077, 353079, 353080, 353081, 353082, 353083, 353084, 353085, 353086, 353087, 353088, 353089, 353090, 353091, 353092, 353094, 353095, 353098, 353100, 353102, 353107, 353109, 353110, 353111, 353112, 353113, 353114, 353116, 353117, 353118, 353119, 353120, 353121, 353122, 353123, 353124, 353125, 353126, 353127, 353130, 353133, 353134, 353145, 353149, 353150, 353151, 353152, 353153, 353155, 353156, 353158, 353159, 353162, 353164, 353167, 353168, 353169, 353171, 353174, 353177, 353181, 353189, 353190, 353191, 353193, 353194, 353196, 353197, 353200, 353201, 353202, 353204, 353205, 353206, 353207, 353208, 353209, 353210, 353211, 353213, 353214, 353215, 353217, 353218, 353219, 353220, 353221, 353222, 353223, 353224, 353225, 353226, 353227, 353228, 353229, 353231, 353232, 353236, 353240, 353241, 353242, 353243, 353244, 353245, 353246, 353247, 353248, 353249, 353250, 353251, 353253, 353254, 353256, 353259, 353260, 353261, 353262, 353266, 353267, 353268, 353269, 353271, 353272, 353273, 353277, 353279, 353280, 353281, 353282, 353283, 353284, 353285, 353287, 353289, 353290, 353291, 353292, 353293, 353294, 353296, 353297, 353298, 353299, 353301, 353302, 353303, 353305, 353306, 353308, 353309, 353311, 353314, 353316, 353317, 353318, 353319, 353320, 353321, 353322, 353323, 353324, 353326, 353327, 353328, 353329, 353330, 353331, 353334, 353336, 353339, 353340, 353347, 353348, 353349, 353350, 353351, 353353, 353357, 353358, 353360, 353361, 353362, 353363, 353364, 353365, 353366, 353367, 353368, 353370, 353372, 353373, 353374, 353376, 353378, 353379, 353381, 353383, 353384, 353386, 353387, 353391, 353392, 353393, 353397, 353398, 353399, 353400, 353403, 353404, 353405, 353406, 353408, 353409, 353410, 353412, 353414, 353420, 353497, 353499, 353500, 353501, 353502, 353504, 353505, 353507, 353508, 353510, 353511, 353514, 353516, 353517, 353518, 353522, 353523, 353524, 353525, 353526, 353527, 353528, 353529, 353531, 353533, 353535, 353577, 353578, 353579, 353582, 353586, 353647, 353648, 353652, 353654, 353655, 353657, 350150, 350170, 350181, 350190, 350197, 350213, 350231, 350907, 350910, 350911, 350913, 351199, 351433, 351437, 351452, 351453, 351465, 351466, 351467, 351468, 351616, 351617, 352705, 352739. Model H197, serial numbers: 310003, 310004, 310006, 310007, 310008, 310010, 310011, 310012, 310013, 310014, 310015, 310017, 310018, 310019, 310020, 310021, 310022, 310023, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310039, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310057, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310067, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310081, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 310098, 310099, 310100, 310102, 310103, 310104, 310105, 310106, 310107, 310108, 310109, 310110, 310111, 310112, 310114, 310115, 310116, 310118, 310119, 310120, 310123, 310124, 310126, 310127, 310128, 310129, 310130, 310131, 310132, 310133, 310134, 310135, 310136, 310137, 310138, 310139, 310140, 310142, 310143, 310144, 310145, 310146, 310147, 310148, 310149, 310150, 310151, 310152, 310153, 310154, 310155, 310156, 310157, 310158, 310159, 310160, 310161, 310162, 310163, 310164, 310165, 310167, 310168, 310170, 310171, 310172, 310173, 310174, 310175, 310176, 310177, 310178, 310179, 310180, 310181, 310182, 310185, 310188, 310189, 310190, 310191, 310192, 310193, 310194, 310195, 310197, 310198, 310199, 310200, 310201, 310202, 310203, 310204, 310206, 310207, 310209, 310210, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310237, 310238, 310239, 310241, 310242, 310243, 310244, 310245, 310246, 310247, 310248, 310250, 310252, 310254, 310255, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310268, 310269, 310270, 310271, 310273, 310275, 310276, 310277, 310281, 310284, 310286, 310288, 310289, 310290, 310291, 310292, 310293, 310294, 310295, 310296, 310299, 310302, 310303, 310304, 310305, 310306, 310307, 310309, 310310, 310312, 310313, 310314, 310315, 310318, 310319, 310320, 310322, 310324, 310327, 310329, 310332, 310333, 310334, 310336, 310338, 310340, 310343, 310344, 310346, 310348, 310349, 310351, 310353, 310354, 310355, 310356, 310359, 310360, 310363, 310364, 310365, 310366, 310367, 310368, 310369, 310370, 310371, 310372, 310373, 310374, 310375, 310376, 310377, 310378, 310379, 310380, 310381, 310382, 310383, 310384, 310385, 310386, 310387, 310388, 310389, 310391, 310392, 310393, 310398, 310402, 310404, 310407, 310408, 310412, 310414, 310415, 310416, 310417, 310418, 310420, 310421, 310424, 310426, 310427, 310428, 310430, 310431, 310432, 310433, 310434, 310435, 310436, 310437, 310440, 310443, 310445, 310446, 310448, 310451, 310454, 310455, 310456, 310457, 310458, 310459, 310460, 310462, 310463, 310466, 310467, 310468, 310469, 310472, 310473, 310474, 310475, 310478, 310481, 310482, 310483, 310484, 310485, 310486, 310488, 310491, 310498, 310499, 310501, 310504, 310508, 310510, 310513, 310514, 310516, 310517, 310519, 310520, 310521, 310522, 310523, 310524, 310525, 310526, 310527, 310528, 310529, 310532, 310533, 310534, 310535, 310536, 310537, 310538, 310539, 310540, 310541, 310542, 310543, 310544, 310545, 310546, 310547, 310548, 310549, 310550, 310551, 310552, 310553, 310554, 310555, 310557, 310558, 310559, 310560, 310562, 310563, 310564, 310565, 310566, 310567, 310568, 310569, 310570, 310571, 310572, 310573, 310574, 310575, 310576, 310578, 310579, 310580, 310581, 310582, 310583, 310584, 310586, 310587, 310589, 310590, 310591, 310592, 310593, 310594, 310596, 310599, 310600, 310602, 310604, 310605, 310606, 310607, 310608, 310609, 310610, 310611, 310612, 310614, 310617, 310618, 310621, 310622, 310623, 310625, 310626, 310627, 310629, 310630, 310631, 310632, 310633, 310634, 310635, 310636, 310637, 310638, 310640, 310642, 310643, 310646, 310649, 310650, 310653, 310654, 310655, 310657, 310658, 310659, 310661, 310662, 310663, 310664, 310665, 310669, 310671, 310674, 310679, 310680, 310684, 310685, 310687, 310690, 310692, 310695, 310697, 310701, 310703, 310710, 310711, 310714, 310715, 310716, 310721, 310722, 310723, 310726, 310728, 310729, 310734, 310736, 310737, 310739, 310784, 310787, 310788, 310827, 310834, 310835, 310836, 310837, 310838, 310843, 310846, 310857, 310885, 310888, 310892, 310895, 310907, 310910, 310929, 310938, 310943, 310952, 310955, 310964, 310974, 310975, 310977, 310984, 310986, 310987, 310991, 310992, 310994, 310995, 310996, 310997, 310999, 311000, 311002, 311010, 311015, 311016, 311017, 311023, 311024, 311025, 311030, 311032, 311033, 311040, 311041. Model H197, serial numbers: 300954, 300956, 300957, 300958, 300961, 300965, 300968, 300974, 300975, 300976, 300977, 300978, 300983, 300984, 300985, 300986, 300988, 300989, 300990, 300991, 300993, 300995, 300997, 300998, 300999, 301000, 301001, 301002, 301006, 301008, 301010, 301011, 301012, 301013, 301014, 301015, 301017, 301022, 301023, 301025, 301026, 301028, 301029, 301032, 301035, 301039, 301042, 301046, 301049, 301051, 301053, 301054, 301058, 301062, 301063, 301065, 301067, 301068, 301069, 301070, 301076, 301079, 301084, 301085, 301086, 301089, 301090, 301093, 301095, 301097, 301098, 301128, 301239, 301241, 301244, 301246, 301247, 301248, 301255, 301256, 301259, 301262, 301263, 301277, 301284, 301304, 301305, 301319, 301325, 301335, 301336, 301339, 301340, 301341, 301342, 301343, 301344, 301345, 301351, 301354, 301355, 301357, 301358, 301360, 301362, 301366, 301372, 301373, 301374, 301379, 301380, 301386, 301387, 301388, 301395, 301403, 301404, 301410, 301418, 301428, 301430, 301432, 301438, 301439, 301440, 301443, 301463, 301476, 301477, 320233, 320234, 320235, 320236, 320237, 320238, 320240, 320241, 320242, 320243, 320245, 320246, 320248, 320249, 320250, 320251, 320252, 320253, 320254, 320256, 320257, 320259, 320260, 320264, 320266, 320267, 320269, 320270, 320271, 320273, 320274, 320275, 320276, 320277, 320278, 320279, 320280, 320281, 320282, 320283, 320284, 320285, 320286, 320287, 320288, 320289, 320291, 320292, 320294, 320295, 320296, 320297, 320298, 320299, 320300, 320301, 320302, 320303, 320304, 320305, 320306, 320307, 320308, 320309, 320310, 320311, 320312, 320313, 320314, 320315, 320316, 320317, 320318, 320319, 320320, 320321, 320322, 320323, 320324, 320325, 320326, 320327, 320331, 320332, 320335, 320336, 320337, 320338, 320339, 320341, 320342, 320343, 320344, 320345, 320346, 320347, 320348, 320349, 320352, 320353, 320354, 320357, 320361, 320362, 320363, 320364, 320365, 320366, 320367, 320368, 320369, 320370, 320372, 320376, 320379, 320380, 320381, 320382, 320383, 320384, 320385, 320386, 320387, 320390, 320392, 320393, 320394, 320395, 320396, 320398, 320399, 320401, 320402, 320403, 320404, 320405, 320406, 320409, 320410, 320411, 320412, 320422, 320423, 320424, 320425, 320426, 320428, 320429, 320431, 320432, 320433, 320434, 320435, 320436, 320438, 320444, 320451, 320452, 320453, 320454, 320455, 320457, 320458, 320460, 320461, 320462, 320463, 320464, 320465, 320466, 320467, 320468, 320469, 320471, 320472, 320473, 320474, 320475, 320476, 320477, 320478, 320479, 320480, 320481, 320482, 320483, 320484, 320485, 320486, 320487, 320488, 320489, 320490, 320492, 320493, 320495, 320496, 320497, 320498, 320500, 320502, 320503, 320504, 320505, 320506, 320507, 320508, 320511, 320515, 320519, 320533, 320534, 320535, 320536, 320537, 320538, 320539, 320540, 320547, 320548, 320550, 320551, 320552, 320553, 320555, 320556, 320557, 320558, 320559, 320560, 320561, 320562, 320563, 320564, 320565, 320566, 320567, 320568, 320569, 320570, 320571, 320572, 320574, 320575, 320576, 320577, 320578, 320579, 320581, 320582, 320588, 320593, 320595, 320596, 320598, 320602, 320608, 320610, 320611, 320612, 320613, 320614, 320615, 320616, 320617, 320618, 320620, 320621, 320622, 320623, 320625, 320626, 320627, 320629, 320643, 320644, 320645, 320646, 320647, 320648, 320649, 320650, 320651, 320653, 320654, 320655, 320656, 320658, 320659, 320660, 320661, 320662, 320663, 320664, 320665, 320666, 320669, 320670, 320671, 320672, 320673, 320674, 320676, 320677, 320678, 320679, 320680, 320681, 320682, 320683, 320684, 320685, 320688, 320689, 320690, 320691, 320692, 320694, 320695, 320696, 320698, 320699, 320701, 320702, 320706, 320708, 320712, 320713, 320714, 320716, 320717, 320719, 320722, 320723, 320724, 320725, 320726, 320727, 320728, 320729, 320731, 320732, 320733, 320734, 320736, 320739, 320740, 320741, 320742, 320743, 320744, 320745, 320746, 320751, 320752, 320753, 320754, 320755, 320756, 320757, 320758, 320759, 320760, 320762, 320763, 320765, 320766, 320767, 320768, 320769, 320770, 320772, 320773, 320774, 320776, 320778, 320779, 320780, 320781, 320782, 320783, 320784, 320785, 320786, 320787, 320788, 320789, 320790, 320792, 320793, 320794, 320795, 320796, 320797, 320798, 320799, 320800, 320801, 320802, 320803, 320804, 320805, 320806, 320807, 320808, 320809, 320810, 320811, 320812, 320813, 320814, 320815, 320816, 320817, 320818, 320819, 320820, 320821, 320822, 320823, 320826, 320827, 320828, 320829, 320830, 320831, 320832, 320833, 320834, 320835, 320836, 320837, 320838, 320839, 320840, 320841, 320843, 320844, 320845, 320846, 320847, 320848, 320849, 320850, 320851, 320852, 320853, 320854, 320855, 320856, 320857, 320858, 320859, 320860, 320861, 320862, 320863, 320864, 320865, 320866, 320867, 320868, 320869, 320871, 320872, 320879, 320884, 320891, 320895, 320915, 320918, 320921, 320922, 320924, 320925, 320926, 320927, 320928, 320931, 320932, 320935, 320943, 320944, 320945, 320946, 320947, 320948, 320949, 320951, 320952, 320953, 320954, 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Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Manufacturer Reason
for Recall
Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
Quantity in Commerce 6,700
Distribution Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CLONMEL LIMITED
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CORPORATION
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CORPORATION (BSC)
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC CRV
PMAs with Product Code = NIK and Applicant = BOSTON SCIENTIFIC-CRM
PMAs with Product Code = NIK and Applicant = CARDIAC PACEMAKERS, INC.
PMAs with Product Code = NIK and Applicant = GUIDANT CORP.
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