Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

Recall details

Manufacturer

Boston Scientific CRM Corp

Distributor

Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.

Lot

Model E102 - Serial Numbers: 240307, 240308, 240310, 240312, 240313, 240318, 240319, 240320, 240321, 240324, 240325, 240326, 240327, 240329, 240330, 240332, 240336, 240338, 240340, 240342, 240344, 240345, 240346, 240348, 240349, 240350, 240351, 240354, 240355, 240356, 240358, 240359, 240360, 240363, 240365, 240366, 240367, 240368, 240369, 240371, 240372, 240373, 240374, 240375, 240376, 240378, 240380, 240383, 240384, 240386, 240389, 240391, 240393, 240397, 240398, 240399, 240401, 240403, 240404, 240405, 240406, 240407, 240408, 240410, 240414, 240415, 240416, 240418, 240421, 240422, 240423, 240424, 240426, 240432, 240433, 240434, 240438, 240439, 240441, 240443, 240444, 240448, 240450, 240451, 240452, 240454, 240455, 240456, 240457, 240459, 240460, 240461, 240462, 240466, 240468, 240471, 240472, 240473, 240474, 240475, 240478, 240479, 240480, 240484, 240485, 240488, 240489, 240490, 240491, 240492, 240493, 240496, 240497, 240500, 240501, 240503, 240505, 240508, 240510, 240511, 240512, 240517, 240519, 240521, 240523, 240524, 240525, 240527, 240529, 240530, 240531, 240533, 240535, 240536, 240537, 240540, 240542, 240544, 240547, 240548, 240549, 240550, 240551, 240552, 240555, 240556, 240557, 240558, 240559, 240561, 240562, 240563, 240566, 240573, 240575, 240576, 240579, 240582, 240583, 240584, 240586, 240587, 240589, 240590, 240591, 240592, 240593, 240594, 240596, 240597, 240598, 240599, 240600, 240602, 240605, 240606, 240607, 240608, 240609, 240610, 240611, 240612, 240615, 240616, 240618, 240619, 240622, 240623, 240624, 240627, 240628, 240630, 240633, 240635, 240636, 240637, 240639, 240640, 240641, 240642, 240644, 240645, 240646, 240647, 240648, 240649, 240650, 240652, 240653, 240655, 240656, 240657, 240658, 240659, 240660, 240663, 240664, 240665, 240666, 240668, 240669, 240672, 240674, 240678, 240679, 240680, 240681, 240687, 240688, 240690, 240692, 240699, 240701, 240703, 240705, 240707, 240708, 240709, 240712, 240713, 240715, 240717, 240718, 240719, 240720, 240722, 240723, 240725, 240726, 240727, 240728, 240729, 240730, 240731, 240732, 240736, 240737, 240738, 240740, 240741, 240743, 240744, 240747, 240749, 240750, 240751, 240752, 240755, 240757, 240758, 240759, 240761, 240762, 240763, 240764, 240765, 240766, 240767, 240768, 240769, 240770, 240771, 240775, 240777, 240778, 240779, 240780, 240781, 240782, 240788, 240791, 240792, 240794, 240797, 240798, 240799, 240800, 240801, 240802, 240803, 240804, 240805, 240806, 240807, 240808, 240810, 240814, 240818, 240821, 240822, 240826, 240828, 240829, 240830, 240832, 240833, 240834, 240835, 240836, 240837, 240840, 240841, 240844, 240845, 240848, 240849, 240850, 240851, 240852, 240853, 240854, 240855, 240858, 240859, 240861, 240862, 240863, 240864, 240865, 240868, 240869, 240870, 240872, 240873, 240874, 240875, 240876, 240877, 240878, 240879, 240881, 240882, 240883, 240884, 240886, 240889, 240890, 240891, 240893, 240894, 240895, 240896, 240897, 240898, 240899, 240900, 240901, 240902, 240903, 240905, 240906, 240910, 240912, 240913, 240914, 240916, 240917, 240918, 240924, 240928, 240932, 240934, 240939, 240941, 240942, 240943, 240944, 240945, 240946, 240949, 240950, 240952, 240953, 240954, 240955, 240956, 240957, 240959, 240960, 240961, 240962, 240965, 240966, 240968, 240969, 240971, 240973, 240975, 240976, 240977, 240979, 240980, 240981, 240982, 240985, 240988, 240990, 240991, 240992, 240993, 240995, 240996, 240997, 240999, 241000, 241001, 241003, 241004, 241005, 241006, 241007, 241010, 241012, 241014, 241017, 241020, 241022, 241023, 241026, 241027, 241028, 241029, 241030, 241031, 241032, 241033, 241034, 241037, 241038, 241039, 241041, 241042, 241044, 241045, 241048, 241050, 241051, 241053, 241054, 241056, 241058, 241060, 241061, 241063, 241064, 241065, 241069, 241074, 241076, 241077, 241079, 241082, 241083, 241085, 241086, 241088, 241089, 241090, 241092, 241093, 241095, 241096, 241097, 241098, 241100, 241101, 241102, 241103, 241104, 241106, 241107, 241108, 241109, 241112, 241113, 241114,

Risk classification

Class II

Area (FDA)

device

Country

United States