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 sl Recall
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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 sl
Brand
Boston Scientific CRM Corp
Lot Codes / Batch Numbers
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
Products Sold
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
Boston Scientific CRM Corp is recalling Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implant due to Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If fu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026