Class 2 Device Recall Guidant VITALITY

• Date Initiated by Firm: May 15, 2006
• Date Posted: July 27, 2006
• Recall Status: Terminated on March 02, 2008
• Recall Number: Z-1292-06
• Recall Event ID: 35525
• PMA Number: P960040
• Product Classification: Implantable Cardioverter Defibrillator - Product Code LWP
• Product: Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are 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-energy shocks using either a biphasic or monophasic waveform. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing).
• Code Information: model T165, serial numbers: 106641, 106643, 106644, 106645, 106646, 106647, 106648, 106649, 106651, 106652, 106676, 106677, 106678, 106679, 106680, 106681, 106683, 106685, 106686, 106687, 106691, 106692, 106693, 106694, 106696, 106697, 106700, 106701, 106702, 106778, 106779, 106780, 106781, 106782, 106788, 106789, 106790, 106792, 106793, 106794, 106795, 106796, 106797, 106798, 106799, 106803, 106804, 106805, 106806, 106807, 106808, 106810, 106813, 106815, 106816, 106817, 106818, 106819, 106820, 106821, 106822, 106823, 106824, 106825, 106826, 106827, 106828, 106829, 106830, 106831, 106832, 106833, 106834, 106835, 106836, 106837, 106838, 106839, 106840, 106841, 106842, 106843, 106844, 106845, 106846, 106847, 106849, 106850, 106851, 106852, 106853, 106854, 106855, 106856, 106857, 106858, 106860, 106861, 106862, 106863, 106864, 106865, 106867, 106868, 106869, 106870, 106871, 106872, 106873, 106874, 106875, 106876, 106877, 106878, 106879, 106880, 106881, 106882, 106883, 106884, 106885, 106886, 106888, 106889, 106890, 106891, 106892, 106894, 106895, 106896, 106898, 106899, 106900, 106901, 106903, 106905, 106906, 106907, 106908, 106909, 106910, 106911, 106914, 106915, 106916, 106917, 106919, 106920, 106922, 106923, 106925, 106926, 106929, 106932, 106935, 106936, 106937, 106939, 106940, 106941, 106942, 106943, 106945, 106946, 106947, 106948, 106949, 106952, 106953, 106954, 106955, 106956, 106957, 106959, 106960, 106962, 106963, 106964, 106965, 106968, 106969, 106970, 106971, 106972, 106973, 106974, 106975, 106976, 106977, 106978, 106979, 106980, 106981, 106982, 106983, 106984, 106985, 106987, 106990, 106991, 106992, 106993, 106996, 106997, 106998, 106999, 107000, 107001, 107002, 107003, 107004, 107007, 107008, 107009, 107010, 107011, 107012, 107013, 107015, 107017, 107018, 107019, 107020, 107021, 107033, 107034, 107035, 107036, 107037, 107039, 107043, 107044, 107045, 107046, 107047, 107057, 107058, 107059, 107060, 107061, 107062, 107064, 107065, 107066, 107067, 107068, 107069, 107070, 107072, 107075, 107077, 107078, 107079, 107082, 107087, 107091, 107092, 107099, 107101, 107102, 107103, 107106, 107110, 107116, 107123, 107124, 107141, 107208, 107210, 107254, 107263, 107264, 107265, 107266, 107267, 107298, 107299, 107300, 107301, 107303, 107304, 107306, 107307, 107308, 107315, 107316, 107317, 107318, 107320, 107321, 107322, 107389, 107718, 108310, 108376, 115934 model T175, serial numbers: 105118, 105119, 105120, 105122, 105126, 105130, 105131, 105140, 105141, 105156, 105157, 105158, 105161, 105162, 105165, 105166, 105167, 105169 105170, 105172, 105173, 105174, 105176, 105177, 105178, 105179, 105180, 105181, 105182, 105183, 105184, 105186, 105187, 105189, 105191, 105192, 105194, 105196, 105197, 105200, 105207, 105208, 105209, 105210, 105211, 105212, 105213, 105217, 105304, 105305, 105306, 105307, 105308, 105364, 105365, 105366, 105367, 105368, 105369, 105370, 105371, 105372, 105373, 105374, 105375, 105376, 105377, 105378, 105379, 105380, 105381, 105382, 105383, 105384, 105385, 105386, 105387, 105388, 105389, 105390, 105391, 105393, 105395, 105397, 105398, 105399, 105400, 105401, 105402, 105403, 105404, 105405, 105406, 105407, 105409, 105410, 105411, 105412, 105413, 105414, 105415, 105416, 105417, 105418, 105419, 105420, 105421, 105422, 105423, 105424, 105425, 105426, 105427, 105428, 105429, 105431, 105432, 105433, 105434 ,105435, 105436, 105437, 105438, 105439, 105440, 105442, 105443, 105444, 105445, 105446, 105447, 105448, 105449, 105450, 105451, 105452, 105453, 105454, 105455, 105456, 105458, 105459, 105460, - 105461, 105462, 105463, 105464, 105465, 105466, 105467, 105468, 105469, 105470, 105471, 105472, 105473, 105474, 105476, 105477, 105478, 105479, 105480, 105481, 105482, 105483, 105484, 105485, 105487, 105488, 105573, 105575, 105576, 105577, 105578, 105579, 105580, 105581, 105584, 105586, 105587, 105588, 105589, 105590, 105591, 105592, 105593, 105594, 105595, 105596, 105598, 105599, 105600, 105602, 105603, 105604, 105605, 105606, 105607, 105611, 105613, 105624, 105625, 105627, 105628, 105629, 105630, 105632, 105633, 105634, 105635, 105636, 105638, 105639, 105640, 105642, 105643, 105644, 105645, 105646, 105647, 105648, 105649, 105650, 105651, 105652, 105654, 105655, 105656, 105657, 105658, 105659, 105660, 105661, 105662, 105663, 105664, 105665, 105666, 105667, 105668, 105669, 105670, 105671, 105672, 105673, 105674, 105675, 105676, 105677, 105678, 105679, 105680, 105681, 105682, 105683, 105687, 105688, 105689, 105690, 105691, 105694, 105705, 105706, 105707, 105712, 105713, 105714, 105715, 105716, 105717, 105718, 105720, 105721, 105722, 105723, 105724, 105725, 105726, 105727, 105728, 105739, 105740, 105741, - 105743, 105744, 105745, 105746, 105747, 105748, 105749, 105750, 105752, 105753, 105754, 105755, 105756, 105757, 105758, 105759, 105760, 105762, 105763, 105764, 105765, 105766, 105767, 105768, 105785, 105786, 105790, 105792, 105796, 105820, 105857, 105881, 105884, 105885, 105895, 105898, 105914, 105915, 105917, 105919, 105923, 105924, 105925, 105926, 105927, 105928, 105929, 105930, 105931, 105932 105933, 105934, 105935, 105936, 105937, 105940, 105944, 105945, 105946, 105947, 105948, 105949, 105950, 105951, 105952, 105953, 106074, 106155, 106156, 106157, 106171, 106172, 106173, 106174, 106177, 106178, 106186, 106187, 106189, 106191, 106199, 106200, 106201, 106212, 106213, 106235, 106282, 106361, 106503, 107047,107301, 107593, 108285 model T125, serial numbers: 113211, 113221, 113222, 113223, 113224, 113241, 113243, 113244, 113272, 113273, 113274, 113275, 113276, 113277, 113278, 113279, 113282, 113283, 113284, 113285, 113286, 113287, 113288, 113291, 113292, 113294, 113295, 113296, 113297, 113298, 113299, 113300, 113301, 113317, 113318, 113319, 113320, 113322, 113323, 113324, 113325, 113326, 113327, 113328, 113329, 113330, 113331, 113333, 113334, 113335, 113336, 113337, 113339, 113340, 113341, 113342, 113343, 113344, 113345, 113346, 113347, 113348, 113349, 113350, 113351, 113352, 113353, 113355, 113356, 113359, 113360, 113362, 113363, 113364, 113365, 113366, 113367, 113368, 113369, 113370, 113372, 113373, 113374, 113375, 113378, 113379, 113380, 113381, 113383, 113384, 113385, 113386, 113387, 113388, 113389, 113390, 113391, 113393, 113394, 113396, 113397, 113398, 113399, 113400, 113403, 113408, 113414, 113417, 113420, 113422, 113425, 113427, 113428, 113429, 113430, 113431, 113433, 113434, 113435, 113487, 113492, 113495, 113496, 113500, 113557, 113643, 113847, 113850, 114102 model T135, serial numbers: 941570, 941572, 941573, 941574, 941578, 941585, 941589, 941590, 941591, 941592, 941593, 941595, 941597, 941601, 941602, 941603, 941604, 941605, 941606, 941607, 941608, 941609, 941610, 941613, 941614, 941615, 941616, 941618, 941619, 941620, 941621, 941622, 941623, 941624, 941625, 941626, 941627, 941628, 941629, 941630, 941632, 941633, 941634, 941652, 941653, 941654, 941680, 941681, 941682, 941683, 941688, 941689, 941690, 941691 941692, 941695, 941696, 941697, 941698, 941699, 941700, 941701, 941702, 941703, 941704, 941709, 941710, 941712, 941715, 941716, 941717, 941718, 941719, 941721, 941722, 941723, 941724, 941725, 941727, 941728, 941732, 941734, 941735, 941736, 941737, 941738, 941739, 941740, 941741, 941742, 941743, 941745, 941747, 941748, 941749, 941750, 941752, 941753, 941754, 941756, 941757, 941759, 941762, 941767, 941775, 941776, 941777, 941778, 941781, 941784, 941786, 941787, 941788, 941789, 941800, 941802, 941803, 941804, 941805, 941807, 941810, 941812, 941813, 941814, 941819, 941829, 941830, 941831, 941845, 941846, 941929, 941930, 941933, 941940, 941948, 941953, 941956, 941962, 941970, 941975, 941978, 941979, 942017
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: Guidant; 866-484-3268
• Manufacturer Reason for Recall: Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.
• FDA Determined Cause: Other
• Action: An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.
• Quantity in Commerce: 672
• Distribution: Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates
• 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