Device Recall Guidant

model H170, serial numbers: 509659, 509677, 509678,  509679, 509685, 509694, 509695, 509696, 509762, 509884,  509974, 510012   model H175, serial numbers: 512665, 512666, 512667, 512668, 512708, 512709, 512710, 512711, 512713, 512719,  512721, 512722, 512723, 512759, 512791, 512793, 513062,  513064, 513073, 513085, 513086, 513227   model H177, serial numbers: 506951, 506953, 506954,  506955, 506956, 506957, 506959, 506960, 506967, 506969,  506970, 506973, 506974, 507013, 507014, 507472   model H179, serial numbers: 508312, 508316, 508322,  508325, 508326, 508336, 508342, 508349, 508404

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 CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.

model H190, serial numbers: 301196, 301198, 301204,  301206   model H195, serial numbers: 306327, 306332, 306333,  306334, 306337, 306339, 306348, 306349, 306351, 306367,  306368, 306378, 306380, 306447

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

These models are not available in the US. || Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform

100160, 100161, 100162

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

CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies

model A155, serial numbers: 113567, 113568, 113569, 113570, 113572, 113574, 113585, 113586, 113587, 113591,  113612, 113613, 113616, 113617, 113618, 113619, 113620,  113621, 113623, 113624, 113626, 113627, 113628, 113629,  113631, 113633, 113635, 113637, 113639, 113640, 113641,  113654, 113659, 113660, 113672, 113674, 113675, 113676,  113678, 113679, 113680, 113681, 113682, 113684, 113686,  113687, 113690, 113693, 113694, 113695, 113696, 113778,  113779, 113781, 113783, 113784, 113789, 113791, 113792,  113814, 113908, 113910, 113912, 113913, 113914, 114083

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

VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

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).