Boston Scientific CRM Corp: 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).

Recall number

Z-1292-06

Recalling firm

Boston Scientific CRM Corp

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).

Status

Terminated

Initiated

2006-05-15

Posted

2006-07-27

Terminated

2008-03-02

Reason

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.

Root 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

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

["P960040"]

Product code

LWP

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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