GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardioverter Defibrillator, Sterile Lot. Guidant Corporation, Hamline Avenue North, St Paul, MN 551124-6798. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
This recall has been terminated (originally issued July 17, 2009).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- March 4, 2009
- Posted
- July 17, 2009
- Terminated
- October 4, 2012
- Recall Number
- Z-1621-2009
- Quantity
- 1271
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. Since that time, the April 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrenc
Distribution
Worldwide Distribution - US including PR and states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, JAPAN, LEBANON, NETHERLANDS, NEW ZEALAND, POLYNESIA, PORTUGAL, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
Lot / Code Info
SERIAL NUMBERS MODEL #T125: 115369, 115371, 115379, 115380, 115381, 115402, 115404, 115406, 115407, 115411, 115412, 115415, 115416, 115417, 115418, 115419, 115420, 115421, 115422, 115423, 115426, 115428, 115430, 115431, 115435, 115438, 115439, 115441, 115502, 115503, 115507, 115514, 115517, 115518, 115520, 115527, 115529, 115531, 115533, 115534, 115536, 115538, 115539, 115540, 115541, 115552, 115553, 115554, 115555, 115556, 115557, 115559, 115562, 115565, 115566, 115568, 115569, 115571, 115573, 115574, 115577, 115579, 115581, 115585, 115586, 115587, 115588, 115589, 115590, 115592, 115593, 115594, 115596, 115598, 115599, 115600, 115601, 115603, 115606, 115608, 115633, 115634, 115635, 115638, 115671, 115675, 115690, 115691, 115695, 115697, 115698, 115780, 115842, 115843, 115847, 115851, 115854, 115856, 115857, 115858, 115861, 115862, 115863, 115868, 115872, 115873, 115874, 115875, 115877, 115880, 115881, 115887, 115890, 115891, 115965, 116111, 116587, 116594, 116684, 115403, 115607 and 115636; and SERIAL NUMBERS MODEL #T127: 103080, 103081, 103082, 103083, 103084, 103086, 103090, 103091, 103092, 103095, 103096, 103097, 103098, 103100, 103101, 103104, 103105, 103106, 103108, 103110, 103111, 103113, 103115, 103116, 103117, 103119, 103120, 103121, 103123, 103125, 103128, 103129, 103133, 103134, 103135, 103138, 103139, 103141, 103142, 103143, 103144, 103145, 103150, 103151, 103152, 103155, 103156, 103157, 103159, 103160, 103165, 103168, 103171, 103172, 103176, 103177 and 103178; and SERIAL NUMBERS MODEL #T135: 943611, 943613, 943614, 943615, 943631, 943632, 943633, 943634, 943635, 943636, 943638, 943639, 943641, 943642, 943643, 943644, 943645, 943648, 943651, 943652, 943653, 943663, 943665, 943675, 943677, 943679, 943682, 943685, 943715 and 944338; and SERIAL NUMBERS MODEL #T165: 111413, 111415, 111416, 111417, 111418, 111419, 111422, 111425, 111432, 111436, 111438, 111440, 111442, 111445, 111447, 111450, 111452, 111466, 111469, 111471, 111472, 111479, 111481, 111482, 111483, 111485, 111499, 111501, 111503, 111504, 111507, 111514, 111515, 111516, 111538, 111540, 111544, 111545, 111546, 111547, 111548, 111549, 111553, 111556, 111557, 111626, 111629, 111630, 111631, 111632, 111633, 111634, 111637, 111638, 111640, 111641, 111643, 111644, 111645, 111646, 111652, 111659, 111666, 111668, 111670, 111672, 111677, 111678, 111679, 111681, 111683, 111690, 111693, 111694, 111695, 111698, 111700, 111701, 111702, 111703, 111704, 111706, 111707, 111708, 111709, 111710, 111711, 111713, 111716, 111717, 111718, 111719, 111722, 111723, 111724, 111726, 111727, 111730, 111731, 111734, 111736, 111737, 111738, 111739, 111747, 111749, 111750, 111752, 111753, 111754, 111756, 111757, 111778, 111802, 111804, 111807, 111810, 111819, 111821, 111838, 111839, 111842, 111843, 111844, 111846, 111847, 111850, 111851, 111852, 111853, 111861, 111863, 111864, 111865, 111867, 111872, 111873, 111874, 111875, 111876, 111878, 111879, 111880, 111881, 111883, 111884, 111887, 111889, 111891, 111893, 111895, 111896, 111897, 111898, 111899, 111900, 111901, 111902, 111903, 111906, 111914, 111918, 111919, 111920, 111921, 111923, 111924, 111926, 111927, 111929, 111931, 111932, 111934, 111935, 111936, 111938, 111940, 111941, 111942, 111943, 111944, 111945, 111947, 111948, 111950, 111951, 111952, 111953, 111955, 111956, 111957, 111964, 111965, 111966, 111969, 111971, 111974, 111977, 111978, 111981, 111984, 111988, 111993, 111996, 111999, 112000, 112001, 112002, 112003, 112004, 112005, 112006, 112007, 112008, 112009, 112012, 112013, 112014, 112016. 112018, 112021, 112022, 112023, 112025, 112028, 112030, 112032, 112033, 112038, 112040, 112049, 112050, 112051, 112053, 112054, 112056, 112057, 112058, 112059, 112061, 112065, 112067, 112068, 112069, 112070, 112071, 112072, 112076, 112077, 112078, 112081, 112083, 112084, 112085, 112089, 112090, 112092, 112093, 112099, 112104, 112107, 112111, 112114, 112115, 112117, 112127, 112131, 112132, 112133, 112135, 112137, 112138, 112139, 112140, 112143, 112144, 112145, 112149, 112150, 112152, 112159, 112161, 112162, 112219, 112237, 112240, 112242, 112244, 112247, 112322, 112341, 112350, 112352, 112353, 112354, 112355, 112357, 112359, 112360, 112364, 112634, 112658, 112751, 112777, 112782, 112785, 112786, 112810, 112875, 112879, 113101, 113150, 113301, 113796, 111421, 111448, 111470, 111477, 111484, 111489, 111500, 111541, 111554, 111555, 111651, 111662, 111669, 111696, 111699, 111714, 111715, 111801, 111805, 111806, 111845, 111870, 111871, 111882, 111885, 111888, 111890, 111894, 111997, 112017, 112036, 112039, 112041, 112048, 112055, 112080, 112086, 112087, 112088, 112096, 112097, 112098, 112102, 112105, 112113, 112129, 112141, 112151, 112160, 112238, 112351, 112473, 112474, 112476 and 112491; and SERIAL NUMBERS MODEL #T167: 103886, 103888, 103890, 103903, 103907, 103912, 103913, 103915, 103917, 103920, 103925, 103926, 103928, 103930, 104268, 104303, 104356, 104357, 104360, 104419, 104423, 104488, 104490, 104502, 104583, 103905, 103906, 103914, 103916, 103927, 104096, 104269, 104420, 104496 and 104497; and SERIAL NUMBERS MODEL #T175: 110174, 110177, 110178, 110180, 110181, 110198, 110247, 110318, 110321, 110322, 110323, 110324, 110325, 110326, 110327, 110330, 110331, 110345, 110347, 110351, 110354, 110356, 110357, 110358, 110361, 110362, 110364, 110365, 110368, 110372, 110374, 110375, 110378, 110381, 110387, 110429, 110432, 110433, 110435, 110437, 110441, 110443, 110445, 110446, 110447, 110459, 110461, 110462, 110471, 110473, 110474, 110475, 110479, 110482, 110483, 110487, 110488, 110492, 110497, 110498, 110540, 110543, 110544, 110548, 110554, 110562, 110565, 110566, 110567, 110571, 110572, 110573, 110574, 110576, 110577, 110579, 110580, 110581, 110582, 110583, 110589, 110590, 110591, 110592, 110597, 110602, 110603, 110605, 110606, 110607, 110608, 110609, 110612, 110617, 110618, 110619, 110620, 110621, 110623, 110625, 110626, 110628, 110698, 110699, 110740, 110741, 110744, 110747, 110756, 110793, 110857, 110858, 110859, 110860, 110862, 110865, 110867, 110871, 110877, 111296, 111993, 110245, 110246, 110248, 110296, 110320, 110344, 110348, 110359, 110369, 110373, 110379, 110384, 110430, 110434, 110439, 110444, 110451, 110455, 110456, 110460, 110463, 110478, 110489, 110490, 110493, 110494, 110496, 110511, 110542, 110559, 110594, 110694, 110700, 110702, 110739, 110743, 110745, 110750, 110751, 110753, 110754, 110755, 110758, 110787, 110790, 110795, 110796, 110797, 110854, 110868, 110870, 110881, 110933, 112361, 110290, 110388, 110442 and 110484; and SERIAL NUMBERS MODEL #T177: 104009, 104012, 104013, 104016, 104019, 104021, 104033, 104039, 103990, 103992, 103993, 103998, 103999, 104000, 104004, 104005, 104007, 104008, 104011, 104015, 104018, 104022, 104027, 104028, 104031, 104034, 104040, 104051 and 104052.
Root Cause
Nonconforming Material/Component
Action Taken
Boston Scientific CRM notified Doctors via sales representatives of an "Urgent Medical Device Information" letter dated March 4, 2009. The letter described the problem and included Description of Issue, Rate of Occurrence, Patient Management Recommendations, Devices Affected, Warranty Program & Further Information. A Boston Scientific " Product Advisory" letter dated March 4, 2009, was also made available to physicians to distribute to patients. The letter informed the patient that their defibrillator was included in a group of devices that might experience a performance issue. For further questions, Contact Boston Scientific CRM at 1-800-227-3422.