Device Recall Guidant VITALITY

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

Cardiovascular Devices

3

Yes

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

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).