FDAFDA · Alimentos y medicamentos·N.º oficial Z-2000-2021
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Publicado el 14 de julio de 2021 · Inicio del retiro: 3 de junio de 2021
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- Worldwide distribution.
- Lote
- a) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 713420, 713440, 713443, 713447, 713454, 713456, 713459, 713461, 713464, 713469, 713470, 713474, 713480, 713483, 713500, 713501, 713506, 713508, 713513, 713515, 713516, 713519, 713528, 713530, 713538, 713542, 713543, 713544, 713548, 713592, 713593, 713614, 713621, 713624, 713625, 713630, 713631, 713633, 713637, 713642, 713646, 713649, 713650, 713651, 713652, 713666, 713669, 713675, 713682, 713695, 713701, 713711, 713719, 713728, 713732, 713738, 713744, 713755, 713766, 713796, 713799, 713842, 714095, 714101, 714274, 714280, 719937, 719963, 719998, 720049, 720218, 720222, 720253, 720280, 707669, 713278, 713312, 713318, 713319, 713320, 713326, 713333, 713335, 713363, 713368, 713372, 713385, 713386, 713388, 713389, 713393, 713399, 713401, 713404, 713407, 713408, 713409, 713411, 713414, 713419, 713426, 713431, 713445, 713446, 713449, 713450, 713453, 713457, 713458, 713460, 713462, 713463, 713468, 713471, 713473, 713475, 713476, 713479, 713481, 713485, 713486, 713487, 713488, 713490, 713492, 713494, 713495, 713496, 713497, 713499, 713503, 713504, 713505, 713507, 713509, 713510, 713518, 713522, 713523, 713524, 713529, 713531, 713532, 713534, 713539, 713540, 713550, 713551, 713552, 713554, 713556, 713558, 713559, 713561, 713563, 713564, 713565, 713566, 713567, 713568, 713569, 713570, 713572, 713575, 713576, 713578, 713579, 713580, 713583, 713584, 713586, 713587, 713590, 713591, 713613, 713615, 713616, 713617, 713619, 713620, 713622, 713623, 713635, 713638, 713639, 713640, 713643, 713655, 713656, 713657, 713659, 713661, 713662, 713664, 713665, 713667, 713668, 713670, 713671, 713672, 713673, 713676, 713677, 713681, 713683, 713686, 713687, 713689, 713694, 713697, 713698, 713702, 713705, 713706, 713707, 713708, 713709, 713712, 713714, 713716, 713717, 713724, 713727, 713729, 713730, 713733, 713735, 713739, 713741, 713742, 713743, 713746, 713749, 713750, 713753, 713756, 713758, 713760, 713763, 713767, 713768, 713771, 713773, 713774, 713775, 713776, 713777, 713779, 713780, 713781, 713782, 713786, 713787, 713788, 713789, 713790, 713791, 713792, 713794, 713795, 713797, 713798, 713801, 713802, 713803, 713805, 713806, 713807, 713808, 713809, 713813, 713814, 713815, 713816, 713817, 713820, 713822, 713823, 713824, 713825, 713827, 713828, 713829, 713830, 713831, 713832, 713833, 713849, 713853, 713858, 713859, 713863, 713866, 713971, 713988, 714040, 714046, 714050, 714055, 714056, 714058, 714060, 714061, 714085, 714096, 714104, 714107, 714111, 719820, 719959, 719960, 719965, 719970, 719977, 720008, 720013, 720015, 720026, 720030, 720034, 720037, 720040, 720123, 720239, 720278 b) L301, Serial Numbers: 100547, 100752, 100822, 100829, 100843, 100845, 100846, 100850, 100852, 100853, 100857, 100863, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100874, 100875, 100876, 100878, 100879, 100881, 100883, 100884, 100889, 100890, 100891, 100892, 100893, 100894, 100895, 100896, 100897, 100899, 100900, 100903, 100904, 100911, 100912, 100913, 100914, 100915, 100916, 100919, 100920, 100921, 100923, 100925, 100926, 100927, 100928, 100929, 100930, 100931, 100932, 100936, 100937, 100938, 100939, 100940, 100941, 100942, 100944, 100946, 100947, 100948, 100949, 100950, 100952, 100955, 100956, 100957, 100958, 100959, 100960, 100962, 100964, 100967, 100968, 100969, 100970, 100971, 100972, 100973, 100975, 100976, 100977, 100979, 100980, 100981, 100982, 100983, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100994, 100995, 100996, 100997, 100999, 101000, 101002, 101003, 101004, 101006, 101008, 101009, 101010, 101011, 101012, 101014, 101015, 101016, 101017, 101018, 101020, 101021, 101022, 101024, 101025, 101032, 101033, 101034, 101036, 101037, 101039, 101040, 101042, 101043, 101044, 101046, 101048, 101050, 101052, 101053, 101059, 101060, 101061, 101063, 101064, 101065, 101066, 101067, 101068, 101069, 101072, 101073, 101074, 101075, 101076, 1010
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.