Class 2 Device Recall VITALITY DR HE

• Date Initiated by Firm: March 23, 2007
• Date Posted: July 11, 2007
• Recall Status: Terminated on March 02, 2008
• Recall Number: Z-1054-2007
• Recall Event ID: 37769
• PMA Number: P010012
• Product Classification: implantable defibrillator - Product Code NIK
• Product: VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing).
• Code Information: Model T180, serial numbers: 200020, 200025, 200029, 200059, 200063, 200065, 200068, 200088, 200109, 200111, 200210, 200237, 200358, 200360, 200362, 200440, 200443, 200480, 200581, 200584, 200627, 200663, 200700, 200717, 200725, 200727, 200730, 200743, 200774, 200801, 200847, 200863, 200868, 200884, 200916, 200918, 200962, 200979, 201013, 201026, 201064, 201077, 201082, 201108, 201115, 201124, 201138, 201149, 201151, 201166, 201171, 201182, 201186, 201222, 201224, 201227, 201243, 201263, 201281, 201283, 201287, 201290, 201297, 201298, 201308, 201332, 201388, 201393, 201396, 201451, 201479, 201481, 201524, 201530, 201539, 201548, 201550, 201582, 201589, 201592, 201617, 201629, 201634, 201649, 201685, 201700, 201701, 201702, 201704, 201731, 201732, 201759, 201763, 201768, 201838, 201841, 201861, 201872, 201874, 201891, 201901, 201905, 201908, 201909, 201927, 201929, 201930, 201931, 201933, 201934, 201936, 201937, 201938, 201939, 201940, 201941, 201942, 201943, 201944, 201945, 201946, 201947, 201948, 201949, 201950, 201951, 201952, 201953, 201954, 201955, 201956, 201957, 201958, 201959, 201960, 201961, 201962, 201963, 201964, 201965, 201966, 201967, 201968, 201969, 201970, 201971, 201973, 201974, 201975, 201976, 201977, 201978, 201979, 201980, 201981, 201982, 201983, 201984, 201985, 201988, 201990, 201991, 201992, 201993, 201994, 201995, 201997, 201998, 201999, 202000, 202001, 202002, 202003, 202004, 202005, 202006, 202007, 202008, 202009, 202010, 202012, 202013, 202014, 202015, 202017, 202018, 202019, 202020, 202021, 202022, 202023, 202024, 202025, 202026, 202028, 202029, 202031, 202032, 202033, 202034, 202036, 202037, 202038, 202039, 202041, 202042, 202043, 202044, 202045, 202046, 202047, 202048, 202049, 202050, 202051, 202052, 202053, 202054, 202055, 202056, 202057, 202058, 202059, 202060, 202061, 202062, 202063, 202066, 202068, 202069, 202070, 202071, 202072, 202073, 202074, 202075, 202076, 202077, 202078, 202079, 202080, 202081, 202082, 202083, 202085, 202086, 202087, 202089, 202090, 202091, 202092, 202094, 202095, 202096, 202097, 202099, 202100, 202101, 202102, 202103, 202104, 202105, 202107, 202108, 202109, 202110, 202111, 202112, 202113, 202114, 202115, 202116, 202117, 202118, 202119, 202121, 202122, 202123, 202124, 202125, 202127, 202128, 202129, 202130, 202131, 202132, 202134, 202135, 202136, 202137, 202138, 202139, 202140, 202141, 202143, 202144, 202145, 202146, 202147, 202148, 202149, 202150, 202152, 202154, 202155, 202156, 202157, 202158, 202159, 202160, 202161, 202162, 202163, 202164, 202165, 202166, 202167, 202168, 202169, 202170, 202171, 202172, 202173, 202174, 202175, 202176, 202177, 202178, 202179, 202180, 202181, 202182, 202183, 202185, 202186, 202187, 202188, 202189, 202191, 202192, 202193, 202194, 202195, 202196, 202197, 202198, 202199, 202201, 202202, 202203, 202204, 202205, 202206, 202207, 202208, 202210, 202211, 202213, 202214, 202215, 202216, 202217, 202218, 202219, 202220, 202221, 202222, 202223, 202224, 202225, 202226, 202227, 202228, 202229, 202230, 202231, 202233, 202234, 202235, 202236, 202237, 202238, 202239, 202241, 202242, 202243, 202244, 202245, 202246, 202247, 202248, 202249, 202251, 202252, 202253, 202254, 202255, 202257, 202258, 202259, 202260, 202261, 202262, 202263, 202264, 202265, 202266, 202267, 202268, 202269, 202270, 202271, 202274, 202275, 202276, 202277, 202278, 202279, 202280, 202282, 202283, 202284, 202285, 202286, 202287, 202288, 202289, 202291, 202292, 202293, 202294, 202295, 202296, 202297, 202298, 202299, 202300, 202301, 202302, 202303, 202305, 202306, 202307, 202308, 202309, 202312, 202313, 202314, 202315, 202316, 202317, 202318, 202319, 202320, 202322, 202323, 202324, 202325, 202326, 202327, 202328, 202329, 202330, 202331, 202332, 202333, 202334, 202335, 202336, 202338, 202339, 202340, 202341, 202342, 202343, 202344, 202345, 202346, 202347, 202349, 202350, 202351, 202352, 202353, 202354, 202355, 202356, 202357, 202358, 202359, 202360, 202361, 202362, 202363, 202364, 202365, 202367, 202368, 202369, 202370, 202371, 202372, 202373, 202374, 202375, 202376, 202377, 202378, 202379, 202380, 202381, 202382, 202383, 202384, 202385, 202386, 202387, 202388, 202389, 202390, 202391, 202392, 202393, 202394, 202395, 202396, 202397, 202398, 202399, 202400, 202401, 202404, 202405, 202407, 202408, 202409, 202411, 202412, 202413, 202414, 202415, 202416, 202417, 202418, 202419, 202420, 202421, 202422, 202423, 202424, 202425, 202426, 202427, 202428, 202429, 202431, 202433, 202434, 202435, 202436, 202437, 202438, 202439, 202440, 202441, 202442, 202443, 202444, 202445, 202446, 202447, 202448, 202449, 202450, 202451, 202452, 202453, 202454, 202455, 202456, 202457, 202458, 202459, 202460, 202461, 202462, 202463, 202464, 202465, 202466, 202467, 202469, 202470, 202471, 202472, 202473, 202474, 202475, 202476, 202477, 202480, 202481, 202482, 202483, 202484, 202485, 202486, 202487, 202488, 202490, 202491, 202492, 202493, 202494, 202495, 202496, 202497, 202499, 202500, 202501, 202502, 202503, 202505, 202506, 202507, 202508, 202509, 202511, 202513, 202514, 202516, 202517, 202518, 202520, 202522, 202523, 202524, 202526, 202528, 202529, 202530, 202534, 202535, 202536, 202537, 202538, 202539, 202540, 202541, 202542, 202544, 202546, 202548, 202549, 202550, 202551, 202552, 202553, 202554, 202555, 202556, 202557, 202558, 202560, 202561, 202562, 202563, 202564, 202565, 202566, 202567, 202568, 202569, 202570, 202572, 202573, 202574, 202575, 202577, 202578, 202579, 202580, 202581, 202582, 202583, 202584, 202585, 202586, 202588, 202590, 202591, 202592, 202594, 202596, 202597, 202598, 202599, 202600, 202601, 202603, 202604, 202606, 202608, 202609, 202610, 202611, 202612, 202614, 202616, 202618, 202619, 202621, 202622, 202624, 202625, 202626, 202628, 202630, 202631, 202633, 202634, 202635, 202636, 202638, 202639, 202640, 202641, 202642, 202643, 202645, 202646, 202647, 202648, 202649, 202650, 202651, 202653, 202655, 202656, 202658, 202659, 202660, 202662, 202666, 202670, 202673, 202674, 202675, 202676, 202677, 202679, 202680, 202681, 202682, 202687, 202688, 202689, 202691, 202692, 202693, 202694, 202696, 202697, 202698, 202699, 202702, 202703, 202704, 202705, 202706, 202709, 202710, 202711, 202712, 202713, 202714, 202715, 202717, 202718, 202722, 202724, 202725, 202734, 202735, 202736, 202738, 202740, 202744, 202745, 202748, 202749, 202750, 202751, 202752, 202757, 202758, 202760, 202761, 202762, 202764, 202766, 202771, 202773, 202774, 202777, 202778, 202779, 202780, 202781, 202783, 202784, 202785, 202786, 202787, 202788, 202789, 202790, 202791, 202793, 202794, 202795, 202796, 202797, 202798, 202799, 202801, 202802, 202803, 202804, 202805, 202806, 202808, 202809, 202812, 202813, 202816, 202818, 202819, 202820, 202821, 202822, 202823, 202825, 202826, 202827, 202828, 202829, 202830, 202831, 202832, 202834, 202835, 202836, 202837, 202838, 202839, 202840, 202841, 202842, 202843, 202844, 202848, 202849, 202851, 202852, 202854, 202856, 202858, 202860, 202861, 202863, 202866, 202867, 202868, 202869, 202871, 202876, 202877, 202878, 202879, 202880, 202881, 202882, 202883, 202884, 202886, 202887, 202888, 202889, 202892, 202895, 202896, 202897, 202899, 202900, 202901, 202902, 202903, 202904, 202906, 202908, 202909, 202910, 202911, 202912, 202913, 202914, 202917, 202918, 202919, 202921, 202922, 202923, 202924, 202926, 202927, 202928, 202929, 202930, 202931, 202932, 202933, 202934, 202935, 202938, 202939, 202940, 202941, 202942, 202943, 202944, 202945, 202946, 202947, 202951, 202952, 202953, 202957, 202958, 202959, 202960, 202961, 202963, 202964, 202965, 202966, 202970, 202971, 202974, 202976, 202979, 202984, 202986, 202988, 202989, 202990, 202992, 202993, 202995, 202997, 202999, 203001, 203011, 203013, 203015, 203016, 203017, 203018, 203021, 203022, 203023, 203028, 203030, 203034, 203036, 203037, 203038, 203040, 203047, 203048, 203055, 203064, 203066, 203067, 203070, 203072, 203078, 203087, 203095, 203097, 203118, 203119, 203121, 203127, 203134, 203137, 203148, 203153, 203155, 203160, 203163, 203164, 203165, 203166, 203167, 203168, 203173, 203174, 203182, 203183, 203184, 203185, 203186, 203187, 203188, 203190, 203195, 203196, 203197, 203204, 203206, 203207, 203210, 203211, 203212, 203213, 203215, 203216, 203217, 203219, 203220, 203223, 203224, 203225, 203227, 203228, 203232, 203235, 203236, 203237, 203239, 203240, 203241, 203244, 203248, 203250, 203258, 203261, 203267, 203269, 203271, 203276, 203280, 203283, 203285, 203289, 203290, 203291, 203293, 203294, 203301, 203302, 203308, 203309, 203312, 203318, 203324, 203327, 203328, 203329, 203335, 203336, 203341, 203346, 203349, 203350, 203353, 203355, 203365, 203367, 203380, 203382, 203386, 203387, 203388, 203390, 203397, 203398, 203405, 203418, 203424, 203426, 203427, 203438, 203453, 203462, 203464, 203465, 203468, 203481, 203488, 203493, 203497, 203498, 203501, 203598, 203599, 203602, 203603, 203606, 203610, 203611, 203615, 203616, 203619, 203627, 203630, 203635, 203637, 203646, 203652, 203662, 203668, 203673, 203674, 203675, 203676, 203680, 203682, 203683, 203685, 203689, 203690, 203693, 203698, 203700, 203703, 203706, 203707, 203712, 203716, 203718, 203722, 203724, 203731, 203734, 203741, 203748, 203751, 203756, 203762, 203769, 203776, 203779, 203782, 203785, 203786, 203788, 203791, 203792, 203793, 203803, 203850, 203856, 203860, 203861, 203862, 203863, 203864, 203865, 203877, 203879, 203886, 203891, 203893, 203898, 203899, 203902, 203903, 203910, 203913, 203917, 203924, 203925, 203927, 203928, 203929, 203930, 203931, 203932, 203935, 203937, 203938, 203939, 203940, 203941, 203942, 203943, 203945, 203946, 203947, 203948, 203949, 203950, 203951, 203952, 203953, 203954, 203955, 203956, 203959, 203960, 203963, 203965, 203966, 203967, 203968, 203969, 203970, 203971, 203972, 203973, 203974, 203975, 203976, 203978, 203980, 203984, 203985, 203986, 203987, 203988, 203989, 203990, 203993, 203996, 204014, 204017, 204018, 204020, 204025, 204029, 204030, 204031, 204035, 204037, 204045, 204046, 204052, 204053, 204054, 204055, 204059, 204061, 204063, 204064, 204070, 204074, 204075, 204076, 204091, 204093, 204094, 204098, 204101, 204103, 204106, 204113, 204114, 204117, 204118, 204119, 204122, 204124, 204130, 204135, 204146, 204150, 204152, 204153, 204162, 204171, 204176, 204181, 204191, 204193, 204197, 204199, 204205, 204206, 204207, 204212, 204214, 204216, 204217, 204219, 204220, 204225, 204227, 204233, 204243, 204249, 204252, 204253, 204254, 204256, 204259, 204260, 204271, 204272, 204274, 204275, 204283, 204291, 204294, 204296, 204302, 204314, 204316, 204323, 204330, 204336, 204337, 204339, 204342, 204343, 204344, 204356, 204361, 204371, 204372, 204374, 204378, 204412, 204415, 204429, 204430, 204434, 204452, 204465, 204467, 204470, 204471, 204472, 204473, 204474, 204475, 204477, 204479, 204485, 204486, 204489, 204492, 204493, 204495, 204498, 204499, 204505, 204509, 204513, 204517, 204536, 204554, 204557, 204558, 204559, 204572, 204581, 204584, 204587, 204594, 204597, 204601, 204605, 204606, 204608, 204611, 204620, 204629, 204633, 204637, 204640, 204642, 204643, 204645, 204648, 204665, 204669, 204670, 204672, 204673, 204676, 204677, 204679, 204680, 204689, 204699, 204702, 204705, 204708, 204712, 204715, 204723, 204724, 204729, 204730, 204734, 204735, 204738, 204746, 204752, 204753, 204758, 204760, 204770, 204773, 204778, 204786, 204789, 204790, 204794, 204797, 204799, 204804, 204805, 204807, 204823, 204825, 204834, 204835, 204840, 204842, 204854, 204856, 204858, 204861, 204863, 204864, 204867, 204872, 204874, 204885, 204896, 204897, 204903, 204909, 204913, 204914, 204916, 204917, 204920, 204921, 204922, 204923, 204936, 204940, 204945, 204946, 204947, 204948, 204950, 204951, 204952, 204955, 204957, 204958, 204959, 204960, 204961, 204962, 204963, 204964, 204968, 204969, 204970, 204973, 204974, 204975, 204979, 204981, 204982, 204983, 204984, 204985, 204986, 204987, 204989, 204990, 204991, 204992, 204993, 204994, 204995, 204996, 204997, 204998, 204999, 205000, 205001, 205002, 205003, 205004, 205006, 205007, 205008, 205009, 205010, 205011, 205013, 205014, 205017, 205018, 205020, 205021, 205022, 205023, 205024, 205025, 205026, 205028, 205029, 205030, 205031, 205032, 205033, 205034, 205035, 205036, 205037, 205038, 205039, 205040, 205041, 205042, 205043, 205044, 205045, 205046, 205047, 205048, 205049, 205050, 205051, 205052, 205053, 205054, 205055, 205056, 205057, 205058, 205059, 205060, 205061, 205062, 205063, 205064, 205065, 205066, 205067, 205069, 205070, 205071, 205072, 205073, 205074, 205075, 205076, 205077, 205078, 205079, 205080, 205081, 205082, 205084, 205085, 205086, 205088, 205089, 205090, 205091, 205092, 205093, 205094, 205095, 205096, 205098, 205099, 205100, 205103, 205104, 205105, 205106, 205107, 205109, 205111, 205113, 205114, 205125, 205126, 205127, 205128, 205129, 205130, 205131, 205132, 205133, 205135, 205136, 205137, 205138, 205139, 205140, 205141, 205142, 205144, 205145, 205147, 205148, 205149, 205151, 205152, 205154, 205155, 205156, 205157, 205158, 205159, 205160, 205161, 205162, 205163, 205164, 205165, 205166, 205167, 205168, 205169, 205170, 205171, 205172, 205173, 205174, 205175, 205176, 205178, 205179, 205180, 205181, 205182, 205183, 205184, 205185, 205186, 205187, 205188, 205189, 205190, 205191, 205192, 205193, 205194, 205195, 205196, 205197, 205198, 205199, 205200, 205201, 205202, 205203, 205204, 205205, 205206, 205207, 205208, 205209, 205210, 205211, 205212, 205214, 205215, 205216, 205217, 205218, 205220, 205221, 205222, 205223, 205224, 205225, 205226, 205227, 205228, 205229, 205230, 205231, 205232, 205233, 205234, 205235, 205238, 205239, 205240, 205243, 205245, 205246, 205247, 205249, 205250, 205251, 205252, 205253, 205255, 205256, 205257, 205258, 205259, 205262, 205263, 205264, 205267, 205268, 205269, 205270, 205271, 205272, 205273, 205274, 205275, 205277, 205278, 205280, 205282, 205284, 205285, 205286, 205287, 205289, 205291, 205292, 205293, 205294, 205295, 205296, 205298, 205300, 205301, 205304, 205305, 205307, 205308, 205309, 205310, 205311, 205312, 205313, 205314, 205316, 205317, 205318, 205319, 205321, 205322, 205323, 205324, 205325, 205326, 205327, 205328, 205329, 205330, 205331, 205332, 205333, 205334, 205335, 205337, 205338, 205339, 205340, 205343, 205345, 205346, 205347, 205348, 205349, 205351, 205352, 205353, 205355, 205356, 205358, 205360, 205361, 205362, 205363, 205364, 205368, 205369, 205370, 205371, 205372, 205373, 205375, 205376, 205379, 205406, 205407, 205409, 205410, 205411, 205413, 205414, 205435, 205437, 205438, 205445, 205461, 205465, 205466, 205467, 205468, 205473, 205476, 205477, 205478, 205479, 205491, 205496, 205498, 205500, 205504, 205505, 205506, 205507, 205508, 205509, 205511, 205513, 205518, 205528, 205529, 205531, 205532, 205539, 205555, 205559, 205561, 205580, 205587, 205588, 205592, 205600, 205603, 205612, 205624, 205625, 205630, 205631, 205633, 205634, 205635, 205636, 205637, 205649, 205935, 205939, 205940, 205943, 200002, 200003, 200004, 200005, 200006, 200007, 200008, 200009, 200010, 200011, 200012, 200013, 200014, 200015, 200016, 200017, 200018, 200021, 200022, 200023, 200024, 200026, 200027, 200028, 200030, 200031, 200032, 200033, 200035, 200036, 200037, 200038, 200039, 200040, 200041, 200042, 200043, 200044, 200045, 200046, 200047, 200048, 200050, 200052, 200053, 200054, 200055, 200056, 200057, 200060, 200061, 200062, 200067, 200071, 200072, 200073, 200074, 200075, 200076, 200079, 200081, 200082, 200083, 200084, 200085, 200086, 200087, 200089, 200090, 200092, 200093, 200094, 200095, 200097, 200098, 200099, 200102, 200104, 200107, 200108, 200110, 200113, 200116, 200118, 200119, 200120, 200121, 200122, 200124, 200125, 200126, 200127, 200139, 200143, 200145, 200146, 200158, 200159, 200161, 200163, 200165, 200166, 200176, 200178, 200179, 200185, 200187, 200188, 200191, 200193, 200197, 200208, 200209, 200211, 200213, 200215, 200216, 200217, 200218, 200219, 200222, 200223, 200224, 200225, 200227, 200228, 200229, 200230, 200231, 200232, 200234, 200236, 200238, 200239, 200243, 200253, 200255, 200267, 200276, 200279, 200280, 200288, 200289, 200299, 200314, 200315, 200319, 200321, 200322, 200324, 200325, 200326, 200327, 200328, 200329, 200347, 200348, 200359, 200361, 200363, 200364, 200365, 200370, 200373, 200374, 200375, 200377, 200380, 200386, 200389, 200396, 200407, 200418, 200419, 200421, 200422, 200423, 200429, 200430, 200431, 200433, 200441, 200446, 200449, 200450, 200451, 200459, 200460, 200464, 200482, 200485, 200487, 200493, 200496, 200497, 200508, 200509, 200510, 200511, 200512, 200513, 200514, 200516, 200517, 200518, 200519, 200522, 200523, 200524, 200526, 200527, 200528, 200532, 200534, 200535, 200539, 200540, 200543, 200547, 200549, 200551, 200553, 200554, 200555, 200556, 200558, 200559, 200560, 200562, 200563, 200564, 200565, 200566, 200567, 200571, 200573, 200574, 200575, 200576, 200578, 200579, 200580, 200582, 200583, 200585, 200586, 200587, 200588, 200589, 200590, 200591, 200592, 200593, 200595, 200597, 200598, 200599, 200600, 200601, 200602, 200603, 200604, 200605, 200606, 200607, 200610, 200611, 200614, 200617, 200618, 200622, 200628, 200631, 200648, 200649, 200650, 200652, 200657, 200658, 200660, 200673, 200674, 200676, 200677, 200678, 200679, 200681, 200682, 200683, 200684, 200685, 200686, 200687, 200689, 200690, 200691, 200692, 200694, 200695, 200696, 200697, 200698, 200699, 200703, 200704, 200705, 200706, 200707, 200708, 200709, 200710, 200711, 200712, 200713, 200714, 200715, 200716, 200718, 200719, 200720, 200721, 200722, 200723, 200724, 200729, 200732, 200735, 200736, 200737, 200738, 200739, 200740, 200741, 200742, 200745, 200746, 200747, 200749, 200750, 200751, 200752, 200753, 200754, 200755, 200756, 200757, 200758, 200759, 200760, 200763, 200764, 200765, 200766, 200767, 200768, 200770, 200773, 200775, 200776, 200777, 200779, 200780, 200781, 200782, 200784, 200785, 200786, 200787, 200788, 200792, 200794, 200795, 200798, 200799, 200802, 200807, 200808, 200815, 200818, 200819, 200843, 200845, 200846, 200848, 200849, 200851, 200855, 200860, 200861, 200865, 200867, 200869, 200870, 200871, 200872, 200873, 200874, 200875, 200877, 200879, 200880, 200881, 200882, 200883, 200886, 200890, 200891, 200896, 200897, 200898, 200899, 200900, 200902, 200903, 200904, 200907, 200908, 200910, 200912, 200913, 200914, 200917, 200919, 200920, 200921, 200922, 200923, 200924, 200925, 200926, 200927, 200929, 200930, 200931, 200932, 200936, 200938, 200940, 200941, 200943, 200947, 200948, 200949, 200951, 200952, 200953, 200954, 200961, 200963, 200964, 200965, 200966, 200967, 200972, 200973, 200975, 200976, 200977, 200980, 200981, 200982, 200989, 200990, 200991, 200992, 200993, 200994, 200996, 200997, 200999, 201000, 201004, 201008, 201009, 201010, 201011, 201012, 201014, 201015, 201016, 201018, 201019, 201020, 201021, 201023, 201024, 201025, 201027, 201029, 201030, 201032, 201033, 201034, 201035, 201037, 201040, 201041, 201042, 201063, 201065, 201066, 201067, 201068, 201069, 201070, 201071, 201072, 201074, 201075, 201076, 201079, 201080, 201081, 201083, 201084, 201085, 201086, 201087, 201088, 201089, 201090, 201092, 201093, 201094, 201096, 201097, 201098, 201099, 201100, 201101, 201102, 201103, 201104, 201105, 201107, 201109, 201110, 201111, 201112, 201114, 201116, 201117, 201118, 201119, 201120, 201122, 201123, 201125, 201126, 201127, 201128, 201129, 201130, 201131, 201132, 201133, 201135, 201137, 201139, 201140, 201141, 201142, 201143, 201144, 201145, 201146, 201147, 201150, 201152, 201153, 201154, 201155, 201156, 201158, 201159, 201160, 201161, 201162, 201163, 201164, 201165, 201168, 201169, 201170, 201173, 201174, 201175, 201176, 201177, 201178, 201180, 201181, 201183, 201185, 201187, 201188, 201190, 201191, 201192, 201193, 201194, 201196, 201197, 201198, 201199, 201202, 201203, 201206, 201207, 201208, 201209, 201210, 201211, 201212, 201214, 201215, 201216, 201217, 201220, 201221, 201223, 201226, 201228, 201229, 201231, 201233, 201234, 201235, 201236, 201237, 201238, 201239, 201240, 201241, 201242, 201244, 201246, 201247, 201248, 201249, 201250, 201251, 201252, 201253, 201254, 201255, 201257, 201258, 201260, 201261, 201264, 201265, 201266, 201267, 201269, 201270, 201273, 201274, 201275, 201276, 201277, 201278, 201279, 201282, 201284, 201285, 201286, 201289, 201291, 201292, 201293, 201294, 201295, 201296, 201299, 201300, 201301, 201302, 201303, 201304, 201305, 201306, 201307, 201309, 201310, 201313, 201314, 201317, 201318, 201319, 201320, 201321, 201322, 201324, 201325, 201326, 201327, 201328, 201329, 201330, 201331, 201335, 201337, 201338, 201340, 201341, 201342, 201343, 201345, 201346, 201347, 201350, 201351, 201352, 201353, 201354, 201355, 201356, 201357, 201358, 201359, 201360, 201361, 201362, 201363, 201364, 201365, 201366, 201367, 201368, 201369, 201370, 201371, 201372, 201373, 201374, 201375, 201377, 201378, 201379, 201380, 201381, 201382, 201383, 201384, 201385, 201387, 201389, 201390, 201391, 201394, 201395, 201397, 201398, 201399, 201400, 201401, 201402, 201403, 201404, 201405, 201406, 201407, 201409, 201410, 201411, 201412, 201413, 201414, 201416, 201417, 201418, 201419, 201420, 201422, 201423, 201424, 201425, 201426, 201427, 201428, 201429, 201431, 201433, 201434, 201436, 201437, 201439, 201440, 201441, 201442, 201443, 201444, 201445, 201446, 201447, 201448, 201449, 201450, 201452, 201453, 201454, 201455, 201456, 201457, 201459, 201460, 201461, 201462, 201463, 201464, 201465, 201466, 201467, 201468, 201469, 201470, 201472, 201473, 201474, 201475, 201476, 201477, 201478, 201480, 201482, 201484, 201485, 201486, 201487, 201488, 201489, 201490, 201491, 201492, 201493, 201494, 201495, 201497, 201498, 201499, 201500, 201501, 201502, 201504, 201505, 201506, 201507, 201508, 201510, 201511, 201513, 201514, 201515, 201516, 201517, 201518, 201519, 201520, 201521, 201522, 201523, 201527, 201528, 201529, 201531, 201534, 201536, 201537, 201538, 201540, 201541, 201542, 201543, 201544, 201545, 201546, 201547, 201549, 201551, 201553, 201554, 201555, 201556, 201557, 201558, 201559, 201560, 201561, 201562, 201563, 201565, 201566, 201568, 201569, 201570, 201571, 201572, 201573, 201574, 201575, 201576, 201578, 201579, 201581, 201583, 201584, 201585, 201586, 201587, 201588, 201590, 201593, 201594, 201595, 201596, 201599, 201600, 201601, 201602, 201603, 201605, 201606, 201607, 201608, 201610, 201611, 201612, 201615, 201616, 201618, 201619, 201620, 201622, 201623, 201624, 201625, 201626, 201627, 201628, 201630, 201631, 201632, 201635, 201636, 201637, 201638, 201639, 201640, 201641, 201642, 201643, 201644, 201645, 201646, 201647, 201648, 201650, 201651, 201653, 201654, 201655, 201656, 201657, 201658, 201659, 201661, 201662, 201664, 201666, 201667, 201668, 201669, 201670, 201672, 201673, 201674, 201675, 201676, 201677, 201678, 201679, 201680, 201681, 201682, 201683, 201684, 201687, 201691, 201693, 201694, 201695, 201696, 201697, 201698, 201699, 201703, 201706, 201707, 201709, 201710, 201711, 201712, 201714, 201716, 201717, 201719, 201720, 201721, 201722, 201724, 201725, 201726, 201727, 201728, 201729, 201730, 201733, 201734, 201735, 201736, 201738, 201739, 201740, 201742, 201743, 201745, 201747, 201748, 201749, 201750, 201751, 201752, 201753, 201754, 201757, 201758, 201761, 201762, 201764, 201765, 201766, 201767, 201769, 201770, 201772, 201773, 201774, 201775, 201776, 201778, 201779, 201780, 201782, 201785, 201786, 201788, 201789, 201790, 201791, 201792, 201793, 201795, 201796, 201797, 201798, 201799, 201800, 201801, 201802, 201803, 201804, 201805, 201806, 201807, 201808, 201809, 201810, 201811, 201812, 201813, 201814, 201816, 201817, 201818, 201819, 201820, 201821, 201822, 201824, 201826, 201827, 201828, 201829, 201830, 201831, 201832, 201833, 201835, 201836, 201837, 201839, 201840, 201842, 201843, 201845, 201846, 201847, 201848, 201849, 201850, 201851, 201852, 201853, 201854, 201856, 201859, 201860, 201862, 201863, 201864, 201865, 201866, 201867, 201868, 201869, 201870, 201871, 201875, 201876, 201877, 201878, 201879, 201880, 201881, 201882, 201883, 201884, 201886, 201887, 201888, 201889, 201890, 201892, 201894, 201895, 201897, 201898, 201899, 201900, 201903, 201904, 201906, 201907, 201910, 201912, 201913, 201914, 201915, 201916, 201917, 201918, 201920, 201921, 201922, 201923, 201924, 201925, 201926, 202403, 202545, 204685.
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 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: Other
• 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: 3,041
• 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 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 = NIK and Original Applicant = Boston Scientific Corp.