FDAFDA · Food and drugs·Recall number Z-2000-2021
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Published July 14, 2021 · Recall initiated: June 3, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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