Device Recall TELIGEN Implantable Cardiac Defibrillator

Model E102, serial numbers: 010347, 241131, 242141, 242171, 242431, 242505, 242543, 242657, 242708, 243839, 243965, 244071, 244521, 244580, 244921, 244928, 245000, 245295, 245479, 245519, 245578, 245583, 245619, 245655, 246303, 246369, 246384, 246395, 246396, 246481, 246498, 246502, 246508, 246511, 246516, 246542, 246546, 246548, 246558, 246561, 246592, 246609, 246618, 246653, 246752, 246756, 246888, 246959, 247313, 247342, 247346, 247417, 247452, 247481, 247614, 247618, 247632, 247663, 247687, 247779, 247788, 247893, 248102, 248353, 248557, 248587, 248622, 248630, 248635, 248670, 248805, 248916, 248933, 248968, 248997, 249064, 249083, 249087, 249130, 249370, 249398, 249454, 249468, 249496, 249533, 249534, 249537, 249538, 249556, 249594, 249602, 249627, 249629, 249631, 249650, 249669, 249727, 249751, 249753, 249777, 249868, 249882, 249925, 249934, 249943, 249954, 249960, 250007, 250020, 250031, 250049, 250067, 250089, 250114, 250120, 250121, 250135, 250139, 250147, 250159, 250191, 250194, 250197, 250206, 250230, 250233, 250234, 250246, 250258, 250279, 250289, 250290, 250306, 250324, 250328, 250330, 250337, 250349, 250368, 250382, 250387, 250400, 250421, 250422, 250424, 250431, 250436, 250482, 250497, 250498, 250518, 250538, 250541, 250544, 250553, 250579, 250585, 250596, 250597, 250599, 250602, 250641, 250660, 250670, 250675, 250679, 250684, 250719, 250772, 250781, 250788, 250790, 250794, 250802, 250805, 250811, 250844, 250848, 250859, 250869, 250873, 250891, 250900, 250929, 250979, 251003, 251005, 251024, 251030, 251041, 251065, 251090, 251119, 251122, 251133, 251140, 251146, 251156, 251157, 251167, 251177, 251184, 251211, 251212, 251215, 251226, 251228, 251233, 251239, 251247, 251248, 251255, 251261, 251277, 251280, 251302, 251312, 251316, 251325, 251328, 251442, 251447, 251459, 251500, 251560, 251563, 251565, 251567, 251568, 251573, 251591, 251594, 251600, 251603, 251614, 251616, 251621, 251623, 251624, 251625, 251626, 251632, 251634, 251638, 251640, 251643, 251650, 251654, 251655, 251656, 251658, 251674, 251675, 251681, 251687, 251689, 251715, 251779, 251789, 251797, 251805, 251806, 251861, 251873, 251874, 251890, 251891, 251893, 251896, 251904, 251928, 251933, 251954, 252013, 252034, 252519, 252521, 252548, 252553, 252554, 252569, 252570, 252573, 252600, 252615, 252621, 252623, 252647, 252661, 252672, 252694, 252718, 252719, 252736, 252739, 252744, 252745, 252754, 252757, 252769, 252819, 252820, 252825, 252835, 252863, 252870, 252926, 252928, 252934, 252954, 252976, 252983, 253000, 253011, 253012, 253015, 253019, 253025, 253073, 253105, 253111, 253121, 253122, 253137, 253170, 253174, 253184, 253189, 253198, 253243, 253249, 253269, 253280, 253328, 253338, 253358, 253360, 253372, 253379, 253386, 253392, 253394, 253405, 253406, 253417, 253428, 253431, 253434, 253439, 253440, 253463, 253466, 253472, 253489, 253492, 253498, 253509, 253511, 253516, 253522, 253533, 253536, 253537, 253549, 253552, 253562, 253565, 253566, 253569, 253575, 253577, 253589, 253596, 253599, 253604, 253610, 253614, 253617, 253618, 253620, 253621, 253626, 253629, 253630, 253632, 253644, 253647, 253648, 253649, 253652, 253658, 253665, 253667, 253671, 253672, 253675, 253686, 253687, 253695, 253707, 253719, 253726, 253734, 253737, 253742, 253745, 253759, 253768, 253778, 253784, 253787, 253788, 253789, 253791, 253792, 253804, 253809, 253818, 253838, 253847, 253851, 253857, 253874, 253878, 253884, 253929, 253933, 253942, 253943, 253945, 253957, 253974, 253977, 254007, 254035, 254076, 254085, 254104, 254114, 254122, 254124, 254130, 254131, 254140, 254148, 254150, 254157, 254166, 254181, 254182, 254185, 254208, 254217, 254224, 254248, 254249, 254258, 254274, 254275, 254279, 254294, 254304, 254316, 254328, 254334, 254375, 254409, 254410, 254417, 254423, 254432, 254436, 254437, 254439, 254462, 254471, 254489, 254498, 254501, 254504, 254507, 254510, 254519, 254520, 254526, 254532, 254575, 254586, 254589, 254601, 254605, 254606, 254611, 254666, 254677, 254682, 254683, 254694, 254697, 254750, 254764, 254770, 254802, 254806, 254827, 254829, 254863, 254864, 254932, 254969, 254986, 255054.  Model E110, serial numbers: 111337, 112160, 116438, 116482, 116485, 117042, 117139, 118578, 119741, 120982, 121094, 121712, 121788, 121926, 121949, 122366, 122400, 122408, 122441, 122484, 122544, 122655, 122668, 122712, 122724, 122790, 122900, 123394, 123524, 123869, 123947, 124820, 124993, 125532, 125601, 125781, 125834, 126201, 126222, 126267, 126281, 126317, 126539, 126712, 126741, 126806, 126807, 126833, 126981, 127006, 127014, 127020, 127044, 127047, 127109, 127120, 127140, 127179, 127210, 127217, 127251, 127373, 127394, 127404, 127408, 127428, 127481, 127514, 127720, 127854, 127886, 127903, 127967, 128025, 128033, 128085, 128091, 128139, 128151, 128274, 128326, 128403, 128469, 128572, 129050, 129056, 129168, 129191, 129293, 129346, 129358, 129435, 129477, 129531, 129540, 129637, 129709, 129754, 129767, 129790, 129797, 129804, 129857, 129867, 129906, 129977, 129990, 130000, 130022, 130041, 130106, 130107, 130120, 130144, 130162, 130164, 130185, 130206, 130271, 130305, 130415, 130447, 130470, 130471, 130577, 130716, 130851, 130980, 131059, 131064, 131135, 131167, 131188, 131226, 131242, 131294, 131358, 131365, 131367, 131425, 131427, 131439, 131466, 131469, 131470, 131481, 131482, 131487, 131493, 131506, 131507, 131512, 131524, 131525, 131540, 131565, 131600, 131604, 131608, 131622, 131626, 131636, 131651, 131653, 131661, 131662, 131674, 131676, 131693, 131694, 131708, 131709, 131716, 131717, 131718, 131723, 131733, 131737, 131764, 131765, 131766, 131779, 131799, 131802, 131824, 131830, 131845, 131853, 131857, 131863, 131864, 131878, 131881, 131893, 131907, 131922, 131925, 131926, 131958, 131965, 131972, 131999, 132016, 132039, 132046, 132050, 132055, 132062, 132070, 132073, 132074, 132079, 132091, 132099, 132102, 132119, 132128, 132131, 132132, 132145, 132147, 132177, 132184, 132236, 132252, 132280, 132387, 132393, 132407, 132422, 132534, 132551, 132577, 132616, 132623, 132636, 132699, 132704, 132734, 132755, 132776, 132869, 132870, 132872, 132873, 132889, 132910, 132917, 132944, 132974, 132990, 133035, 133047, 133053, 133112, 133131, 133188, 133198, 133225, 133291, 133295, 133338, 133351, 133388, 133419, 133422, 133466, 133508, 133551, 133591, 133608, 133632, 133634, 133652, 133695, 133713, 133717, 133746, 133766, 133781, 133821, 133833, 133843, 133855, 133863, 133894, 133896, 133906, 133913, 133933, 133936, 133953, 133955, 133956, 133969, 133976, 133999, 134013, 134040, 134044, 134049, 134056, 134060, 134062, 134064, 134088, 134093, 134094, 134115, 134129, 134138, 134159, 134235, 134237, 134277, 134281, 134306, 134312, 134320, 134329, 134339, 134351, 134353, 134355, 134359, 134360, 134365, 134367, 134369, 134374, 134375, 134382, 134385, 134401, 134404, 134417, 134429, 134435, 134441, 134458, 134471, 134480, 134481, 134489, 134511, 134517, 134519, 134536, 134539, 134545, 134559, 134565, 134577, 134581, 134587, 134592, 134604, 134608, 134618, 134631, 134634, 134646, 134652, 134667, 134685, 134694, 134710, 134711, 134715, 134716, 134718, 134720, 134725, 134743, 134749, 134776, 134783, 134797, 134823, 134827, 134829, 134842, 134861, 134867, 134883, 134906, 134910, 134939, 134948, 134952, 134954, 134978, 134987, 135004, 135018, 135023, 135045, 135059, 135060, 135067, 135069, 135073, 135079, 135098, 135110, 135123, 135130, 135140, 135144, 135194, 135226, 135230, 135258, 135261, 135287, 135297, 135299, 135304, 135326, 135327, 135329, 135332, 135333, 135341, 135350, 135355, 135363, 135377, 135385, 135389, 135406, 135408, 135415, 135422, 135426, 135428, 135431, 135434, 135453, 135455, 135466, 135472, 135473, 135475, 135480, 135489, 135499, 135504, 135513, 135514, 135571, 135581, 135591, 135604, 135659, 135712, 135718, 135826, 135868, 135938, 136008, 136042, 136076, 136284, 136323, 136369, 137744, 137765, 137776, 137780, 137787, 137803, 137818, 137847, 137850, 137852, 137868, 137869, 137870, 137872, 137903, 137907, 137924, 137928, 137953, 137957, 137975, 138009, 138025, 138035, 138053, 138063, 138082, 138084, 138090, 138091, 138115, 138132, 138155, 138163, 138168, 138193, 138199, 138209, 138212, 138231, 138244, 138263, 138266, 138327, 138330, 138355, 138360, 138361, 138369, 138383, 138388, 138389, 138405, 138412, 138413, 138416, 138448, 138460, 138462, 138468, 138472, 138479, 138480, 138504, 138517, 138518, 138545, 138546, 138547, 138564, 138581, 138584, 138588, 138596, 138598, 138605, 138628, 138630, 138646, 138669, 138692, 138697, 138698, 138709, 138720, 138727, 138736, 138739, 138744, 138764, 138771, 138776, 138780, 138816, 138819, 138834, 138839, 138841, 138846, 138849, 138856, 138858, 138877, 138900, 138918, 138935, 138940, 138941, 138942, 138955, 138962, 138974, 138977, 138978, 139018, 139028, 139031, 139039, 139042, 139044, 139046, 139050, 139053, 139060, 139067, 139085, 139086, 139098, 139101, 139109, 139113, 139128, 139129, 139130, 139182, 139207, 139219, 139223, 139237, 139263, 139300, 139315, 139337, 139345, 139351, 139361, 139372, 139373, 139387, 139394, 139396, 139403, 139408, 139412, 139413, 139418, 139421, 139423, 139430, 139435, 139447, 139448, 139456, 139458, 139459, 139460, 139461, 139467, 139468, 139472, 139494, 139503, 139507, 139511, 139529, 139546, 139547, 139563, 139569, 139575, 139579, 139590, 139598, 139599, 139612, 139613, 139622, 139636, 139640, 139651, 139652, 139668, 139671, 139683, 139685, 139689, 139715, 139746, 139748, 139760, 139768, 139773, 139793, 139802, 139817, 139824, 139840, 139842, 139846, 139852, 139854, 139855, 139863, 139871, 139878, 139887, 139888, 139894, 139896, 139906, 139910, 139911, 139917, 139918, 139924, 139925, 139926, 139928, 139929, 139931, 139934, 139936, 139942, 139949, 139952, 139953, 139959, 139963, 139964, 139971, 139973, 139980, 139984, 139985, 139987, 140001, 140005, 140007, 140010, 140011, 140016, 140019, 140029, 140030, 140044, 140046, 140053, 140056, 140071, 140075, 140102, 140121, 140125, 140127, 140135, 140137, 140150, 140157, 140180, 140182, 140184, 140186, 140199, 140202, 140204, 140215, 140217, 140222, 140224, 140227, 140234, 140241, 140251, 140256, 140269, 140271, 140299, 140302, 140310, 140311, 140312, 140322, 140326, 140338, 140340, 140346, 140365, 140383, 140389, 140404, 140435, 140525, 140535, 140574, 140637, 140648, 140650, 140651, 140656, 140672, 140674, 140682, 140696, 140717, 140720, 140721, 140722, 140730, 140738, 140769, 140773, 140782, 140795, 140800, 140814, 140831, 140833, 140847, 140869, 140875, 140891, 140899, 140913, 140944, 140950, 140984, 141016, 141035, 141144, 141145, 141195, 141257, 141260, 141270, 141322, 141438, 141470, 141492, 141511, 141594, 141646, 141753.

Cardiovascular Devices

3

Yes

nationwide within US only (OUS distribution not affected).

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.