Guidant VITALITY 2 (models T165, T175), VITALITY DS (model… recallZ-1292-06 · Boston Scientific CRM Corp · initiated May 15, 2006
Terminated All recalls posted in July 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific CRM Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1292-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 15, 2006
- Posted by the FDA
- Jul 27, 2006
- Recalling firm
- Boston Scientific CRM Corp
- Quantity
- 672
- Product code
- LWP
- FDA submissions
- P960040
- 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
Product description
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 (models, lots, serial numbers)
Show the full code information (8k characters)
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
Other devices under the same FDA submission
45 devices cleared under P960040 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- DYNAGEN™ EL ICD DR D152Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)12 deaths1,208 reports
- INOGEN™ EL ICD DR D142Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)6 deaths1,017 reports
- RESONATE™ EL ICD DR D433Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 deaths965 reports
- DYNAGEN™ EL ICD DR D153Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 deaths886 reports
- MOMENTUM™ EL ICD DR D121Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 deaths850 reports
- DYNAGEN™ EL ICD VR D150Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)8 deaths831 reports
- INOGEN™ EL ICD VR D140Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 deaths823 reports
- ENERGEN™ ICD E140Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)3 deaths819 reports
- VIGILANT™ EL ICD VR D232Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)8 deaths750 reports
- ENERGEN™ ICD E142Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 death705 reports
- INCEPTA™ ICD E160Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths601 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 35525).
- Z-1288-06 · TerminatedGuidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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