Z-1292-06

Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable...

Name: Z-1292-06 Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable...
Creator: Boston Scientific CRM Corp
Published: 2006-05-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-15 / Terminated / root cause: supplier

FDA source

Boston Scientific CRM Corp began a recall of Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to... on 2006-05-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1292-06
Status: Terminated
Initiated: 2006-05-15
Posted: 2006-07-27
Terminated: 2008-03-02
Recalling firm: Boston Scientific Corporation
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).
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
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.
Root cause tag: supplier
FDA 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 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
Product codes and lots: 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

Product code LWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)