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RecallWatchMedical Device Safety
Class IOngoingZ-2360-2026

Abiomed, Inc. recalls Automated Impella Controller (AIC)

Abiomed, Inc.Danvers, MA, United StatesReported Jun 24, 2026 · 4 months ago
Legal News Analyst ·

Reason for recall

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Lot / code information

GTIN
00813502010886
Serial #
IC5341, IC5523, IC5677, IC6531, IC5525, IC6529 — +18 moreShow all
IC5341, IC5523, IC5677, IC6531, IC5525, IC6529, IC5836, IC5524, IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6527, IC6526, IC6528, IC6530, IC5622, IC5752, IC5521, IC5522, IC5217, IC5216. 2. Product Code: 0042-0000-CA
GTIN
00813502011272
Serial #
IC9415, IC9413, IC9416, IC9414, IC8283, IC7716 — +38 moreShow all
IC9415, IC9413, IC9416, IC9414, IC8283, IC7716, IC7695, IC7694, IC6635, IC6636, IC6633, IC6634, IC6082, IC6083, IC5821, IC5824, IC5680, IC3802, IC2035, IC1912, IC5034, IC5050, IC4944, IC4945, IC3803, IC3661, IC3662, IC2686, IC2687, IC2033, IC1913, IC1790, IC1791, IC1911, IC1715, IC1769, IC1664, IC1595, IC1598, IC1543, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU
GTIN
00813502011289
Serial #
IC7809, IC7720, IC7721, IC7748, IC7719, IC7718 — +851 moreShow all
IC7809, IC7720, IC7721, IC7748, IC7719, IC7718, IC7717, IC7691, IC7692, IC7693, IC7689, IC7690, IC7687, IC7688, IC7675, IC7686, IC7674, IC7667, IC7655, IC7666, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7646, IC7653, IC7654, IC7613, IC7614, IC7615, IC7580, IC7578, IC7579, IC7576, IC7577, IC7421, IC7455, IC7407, IC7395, IC7406, IC7393, IC7394, IC7388, IC7389, IC7390, IC7392, IC7378, IC7286, IC7265, IC7263, IC7264, IC7261, IC7262, IC7258, IC7259, IC7260, IC7098, IC7099, IC7100, IC7078, IC7093, IC7087, IC7092, IC7096, IC7097, IC7094, IC7095, IC7077, IC7075, IC7076, IC6880, IC6876, IC6877, IC6878, IC6879, IC6845, IC6843, IC6813, IC6814, IC6810, IC6812, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6716, IC6717, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6713, IC6714, IC6710, IC6712, IC6711, IC6715, IC6708, IC6709, IC6594, IC6595, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6591, IC6592, IC6593, IC6579, IC6577, IC6578, IC6587, IC6588, IC6589, IC6590, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6487, IC6488, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6432, IC6435, IC6434, IC6431, IC6331, IC6270, IC6064, IC6205, IC6275, IC6273, IC6274, IC6225, IC6236, IC6272, IC6223, IC6224, IC6149, IC6150, IC6151, IC6147, IC6081, IC6078, IC5818, IC5817, IC5781, IC5775, IC5777, IC5779, IC5755, IC5756, IC5754, IC5715, IC5716, IC5717, IC5685, IC5686, IC5611, IC5714, IC5722, IC5683, IC5684, IC5688, IC5560, IC5681, IC5682, IC5559, IC5518, IC5520, IC5517, IC5177, IC4839, IC4565, IC5519, IC5495, IC5496, IC5494, IC5490, IC5491, IC5492, IC5493, IC5487, IC5488, IC5476, IC5477, IC5460, IC5461, IC5463, IC5464, IC5462, IC5443, IC5441, IC5442, IC5440, IC5435, IC5436, IC5433, IC5434, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5252, IC5195, IC5048, IC5193, IC5194, IC5178, IC5175, IC5176, IC5173, IC5174, IC5210, IC5212, IC5171, IC5169, IC5086, IC5051, IC5053, IC5075, IC5057, IC5087, IC5088, IC5046, IC5047, IC5049, IC5008, IC5009, IC4973, IC5007, IC4984, IC4986, IC4987, IC4988, IC4933, IC4934, IC4931, IC4932, IC4850, IC4928, IC4929, IC4930, IC4623, IC4470, IC4912, IC4917, IC4913, IC4915, IC4914, IC4916, IC4846, IC4837, IC4833, IC4834, IC4835, IC4836, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4792, IC4793, IC4794, IC4795, IC4763, IC4790, IC4791, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4723, IC4724, IC4728, IC4729, IC4725, IC4727, IC4679, IC4680, IC4677, IC4678, IC4657, IC4658, IC4648, IC4649, IC4646, IC4647, IC4645, IC4656, IC4634, IC4635, IC4636, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4624, IC4627, IC4613, IC4614, IC4611, IC4569, IC4566, IC4568, IC4610, IC4612, IC4609, IC4597, IC4598, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4562, IC4563, IC4505, IC4506, IC4508, IC4501, IC4471, IC4500, IC4469, IC4466, IC4467, IC4464, IC4465, IC4468, IC4442, IC4443, IC4444, IC4445, IC4446, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4359, IC4360, IC4358, IC4329, IC4328, IC4234, IC4362, IC4363, IC4356, IC4357, IC4323, IC4324, IC4325, IC4326, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4241, IC4240, IC4254, IC4255, IC4256, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4218, IC4217, IC4209, IC4211, IC4175, IC4153, IC4151, IC4152, IC4150, IC4146, IC4147, IC4148, IC4149, IC4128, IC4129, IC4099, IC4100, IC4096, IC4097, IC4098, IC4083, IC4081, IC4036, IC4037, IC4034, IC4035, IC4033, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3891, IC3889, IC3866, IC3867, IC3868, IC3869, IC3859, IC3861, IC3833, IC3834, IC3862, IC3863, IC3885, IC3886, IC3884, IC3870, IC3871, IC3872, IC3873, IC3874, IC3864, IC3860, IC3832, IC3830, IC3831, IC3828, IC3829, IC3815, IC3816, IC3777, IC3817, IC3818, IC3813, IC3814, IC3781, IC3782, IC3780, IC3812, IC3778, IC3724, IC3718, IC2710, IC3717, IC3706, IC3707, IC3708, IC3701, IC3703, IC3709, IC3698, IC3702, IC3699, IC3700, IC3697, IC3696, IC3673, IC3671, IC3672, IC3668, IC3670, IC3657, IC3669, IC3667, IC3495, IC3489, IC3492, IC3493, IC3486, IC3488, IC3487, IC3491, IC3659, IC3660, IC3490, IC3485, IC3484, IC3477, IC3472, IC3469, IC3470, IC3471, IC3467, IC3461, IC3462, IC3463, IC3466, IC3468, IC3458, IC3459, IC3331, IC3332, IC3460, IC3330, IC3329, IC3323, IC3313, IC3319, IC3327, IC3328, IC3324, IC3303, IC3321, IC3322, IC3317, IC3318, IC3315, IC3310, IC3314, IC3316, IC3311, IC3304, IC3305, IC3301, IC3302, IC3299, IC3300, IC3297, IC3298, IC3296, IC3291, IC3290, IC3289, IC3292, IC3286, IC3288, IC3287, IC3182, IC3183, IC3180, IC3181, IC3178, IC3179, IC3143, IC3144, IC3145, IC3146, IC3142, IC3147, IC3148, IC3149, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3097, IC3098, IC3095, IC3096, IC3069, IC3070, IC3067, IC3068, IC3053, IC3054, IC3051, IC3052, IC3049, IC3021, IC3022, IC3018, IC3020, IC3019, IC3015, IC3016, IC3017, IC2996, IC2997, IC2987, IC2988, IC2984, IC2985, IC2960, IC2878, IC2961, IC2963, IC2962, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2862, IC2860, IC2861, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2835, IC2837, IC2836, IC2838, IC2828, IC2827, IC2766, IC2765, IC2823, IC2824, IC2825, IC2826, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2751, IC2709, IC2752, IC2708, IC2678, IC2679, IC2676, IC2677, IC2670, IC2669, IC2668, IC2659, IC2658, IC2656, IC2657, IC2654, IC2655, IC2652, IC2653, IC2607, IC2609, IC2606, IC2560, IC2512, IC2556, IC2557, IC2491, IC2534, IC2490, IC2494, IC2483, IC2486, IC2481, IC2484, IC2485, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2469, IC2470, IC2472, IC2412, IC2332, IC2411, IC2330, IC2329, IC2326, IC2327, IC2325, IC2242, IC2267, IC2268, IC2266, IC2241, IC2243, IC2234, IC2236, IC2232, IC2233, IC2204, IC2207, IC2222, IC2206, IC2220, IC2205, IC2099, IC2178, IC2179, IC2239, IC2240, IC2244, IC2235, IC2231, IC2173, IC2174, IC2171, IC2172, IC2101, …
GTIN
00813502011418
Serial #
IC6475, IC6139, IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6477, IC6478, IC6476, IC6252, IC6253, IC6254. 5. Product Code: 0042-0000-JP
GTIN
00813502010428
Serial #
IC7901, IC8276, IC8277, IC8278, IC8279, IC8281 — +294 moreShow all
IC7901, IC8276, IC8277, IC8278, IC8279, IC8281, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8050, IC7929, IC7899, IC7900, IC7808, IC7811, IC8047, IC8048, IC8049, IC8051, IC8053, IC8054, IC8076, IC8077, IC7984, IC7853, IC7981, IC7982, IC7983, IC7985, IC8046, IC7934, IC7905, IC7926, IC7927, IC7933, IC7976, IC7979, IC7935, IC7977, IC7978, IC7980, IC7779, IC7902, IC7903, IC7897, IC7898, IC7852, IC7896, IC7812, IC7813, IC7814, IC7815, IC7846, IC7784, IC7785, IC7806, IC7782, IC7783, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7413, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7434, IC7435, IC7439, IC7440, IC7433, IC7412, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7385, IC7386, IC7387, IC7383, IC7384, IC7291, IC7293, IC7294, IC7295, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7068, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6658, IC6659, IC6652, IC6653, IC6654, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6642, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6650, IC6651, IC6656, IC6657, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6468, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6203, IC6204, IC6210, IC6211, IC6212, IC5866, IC5867, IC5868, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6049, IC6046, IC6047, IC6048, IC5935, IC5936, IC5937, IC5938, IC5862, IC5863, IC5930, IC5864, IC5865, IC5819, IC5820, IC5860, IC5861, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5478, IC5447, IC5444, IC5445, IC5259, IC5260, IC5261, IC5241, IC5243, IC5245, IC5027, IC4732. 6. Product Code: 0042-0000-UK
Show 4 more code fields
GTIN
00813502011296
Serial #
IC7668, IC7669, IC7670, IC7591, IC7073, IC7847 — +125 moreShow all
IC7668, IC7669, IC7670, IC7591, IC7073, IC7847, IC7848, IC7585, IC7443, IC7441, IC7074, IC7671, IC7070, IC7071, IC7444, IC7445, IC7446, IC7447, IC7069, IC7057, IC7056, IC6925, IC6585, IC6586, IC6583, IC6584, IC6542, IC6543, IC6537, IC6538, IC6638, IC6669, IC6670, IC6671, IC6291, IC6292, IC6286, IC6287, IC6289, IC6290, IC5914, IC5915, IC5926, IC5927, IC6001, IC5995, IC5996, IC5997, IC5998, IC5999, IC5910, IC5833, IC5831, IC5832, IC5554, IC5555, IC5553, IC5247, IC5830, IC5557, IC5213, IC5182, IC5180, IC5211, IC5254, IC5253, IC5219, IC5220, IC5218, IC5184, IC5214, IC5215, IC5179, IC5181, IC4857, IC4843, IC4844, IC4841, IC4842, IC4926, IC4927, IC4739, IC4741, IC4721, IC4722, IC4599, IC4600, IC4439, IC4440, IC4330, IC4166, IC3784, IC3785, IC3674, IC3474, IC3334, IC3333, IC3326, IC3325, IC3312, IC3295, IC3293, IC3294, IC2871, IC2872, IC2706, IC2707, IC2704, IC2705, IC2493, IC2497, IC2492, IC2496, IC2367, IC2023, IC1910, IC2024, IC2025, IC1909, IC1869, IC1868, IC1792, IC1581, IC1582, IC1583, IC1542, IC1519, IC1573, IC1387, IC1389, IC1388. 7. Product Code: 0042-0000-US
GTIN
00813502010022
Serial #
IC4744, IC7919, IC7922, IC7026, IC7028, IC7027 — +2628 moreShow all
IC4744, IC7919, IC7922, IC7026, IC7028, IC7027, IC7030, IC7032, IC6983, IC6984, IC6982, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6930, IC6931, IC6932, IC6933, IC6935, IC6926, IC6927, IC6928, IC6929, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6898, IC6897, IC6916, IC6917, IC6889, IC6893, IC6894, IC6895, IC6901, IC6914, IC6915, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6896, IC6899, IC6900, IC6904, IC6905, IC6906, IC6907, IC6841, IC6842, IC6840, IC6837, IC6838, IC6839, IC6836, IC6833, IC6829, IC6826, IC6827, IC6828, IC6831, IC6832, IC6811, IC6815, IC6865, IC6774, IC6864, IC6802, IC6803, IC6830, IC6801, IC6800, IC6798, IC6799, IC6823, IC6796, IC6797, IC6847, IC6848, IC6849, IC6824, IC6825, IC6846, IC6770, IC6771, IC6772, IC6773, IC6850, IC6851, IC6852, IC6853, IC6854, IC6769, IC6820, IC6822, IC6819, IC6775, IC6816, IC6817, IC6818, IC6767, IC6768, IC6732, IC6753, IC6754, IC6755, IC6766, IC6737, IC6743, IC6744, IC6733, IC6734, IC6735, IC6736, IC6515, IC4405, IC4404, IC6730, IC6731, IC6726, IC6727, IC6729, IC6725, IC6723, IC6724, IC6722, IC6718, IC6719, IC6720, IC6721, IC6678, IC6679, IC6680, IC6681, IC6682, IC6683, IC6684, IC6685, IC6686, IC6687, IC6675, IC6676, IC6677, IC6672, IC6674, IC6673, IC6668, IC6667, IC6663, IC6664, IC6665, IC6666, IC6647, IC6648, IC6649, IC6645, IC6646, IC6640, IC6641, IC6643, IC6644, IC6639, IC6637, IC6626, IC6627, IC6628, IC6629, IC6630, IC6631, IC6632, IC6624, IC6625, IC6620, IC6621, IC6622, IC6623, IC6619, IC6616, IC6617, IC6618, IC6613, IC6614, IC6615, IC6611, IC6612, IC6603, IC6604, IC6602, IC6601, IC6598, IC6599, IC6600, IC6596, IC6597, IC6575, IC6576, IC6573, IC6574, IC6569, IC6570, IC6571, IC6572, IC6568, IC6565, IC6566, IC6567, IC6563, IC6564, IC6562, IC6560, IC6561, IC6557, IC6558, IC6559, IC6544, IC6545, IC6546, IC6547, IC6524, IC6525, IC6522, IC6523, IC6518, IC6520, IC6521, IC6514, IC6516, IC6517, IC6511, IC6512, IC6513, IC6505, IC6506, IC6507, IC6508, IC6509, IC6504, IC6502, IC6503, IC6500, IC6499, IC6501, IC6497, IC6498, IC6448, IC6495, IC6496, IC6428, IC6445, IC6446, IC6447, IC6485, IC6486, IC6483, IC6484, IC6481, IC6482, IC6480, IC6433, IC6438, IC6479, IC6471, IC6472, IC6473, IC6470, IC6454, IC6455, IC6453, IC6426, IC6427, IC6444, IC6450, IC6415, IC6412, IC6413, IC6414, IC6411, IC6408, IC6409, IC6410, IC6404, IC6402, IC6403, IC6400, IC6401, IC6397, IC6398, IC6399, IC6045, IC6390, IC6391, IC6392, IC6393, IC6394, IC6395, IC6396, IC6361, IC6362, IC6363, IC6364, IC6365, IC6366, IC6367, IC6368, IC6369, IC6288, IC6295, IC6352, IC6353, IC6354, IC6355, IC6356, IC6357, IC6358, IC6359, IC6332, IC6333, IC6334, IC6335, IC6346, IC6347, IC6348, IC6349, IC6350, IC6351, IC6330, IC6328, IC6329, IC6326, IC6327, IC6325, IC6323, IC6324, IC6319, IC6320, IC6317, IC6318, IC1250, IC6095, IC6268, IC6269, IC6271, IC6255, IC6266, IC6267, IC6251, IC6250, IC6247, IC6248, IC6249, IC6244, IC6245, IC6246, IC6243, IC6242, IC6239, IC6240, IC6241, IC5933, IC6237, IC6238, IC6222, IC6220, IC6221, IC6218, IC6219, IC6217, IC6206, IC6208, IC6213, IC6215, IC6200, IC6201, IC6195, IC6196, IC6197, IC6198, IC6199, IC6194, IC6192, IC6193, IC6190, IC6191, IC6186, IC6187, IC6188, IC6189, IC6184, IC6185, IC6182, IC6183, IC6177, IC6178, IC6179, IC6180, IC6181, IC6176, IC6156, IC6157, IC6158, IC6159, IC6160, IC6161, IC6154, IC6155, IC6152, IC6153, IC6141, IC6144, IC6145, IC6146, IC6133, IC6134, IC6136, IC6142, IC6143, IC6140, IC6115, IC6135, IC6137, IC6138, IC5565, IC6129, IC6130, IC6131, IC6132, IC6128, IC6105, IC6106, IC6107, IC6103, IC6104, IC6100, IC6101, IC6102, IC6092, IC6093, IC6094, IC6096, IC6097, IC6098, IC6099, IC6077, IC6059, IC6063, IC6061, IC6062, IC6058, IC6060, IC6056, IC6057, IC6054, IC6055, IC6053, IC6051, IC6052, IC6050, IC6041, IC6043, IC6044, IC6042, IC6039, IC6040, IC6035, IC6036, IC6037, IC6038, IC6034, IC6000, IC6028, IC6029, IC6030, IC6031, IC6032, IC6033, IC6026, IC6027, IC6005, IC6002, IC6003, IC6004, IC5991, IC5992, IC5993, IC5994, IC5983, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, 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…
Additional code information

IC2425, IC2426, IC2409, IC2417, IC2418, IC2419, IC2420, IC2422, IC2424, IC2415, IC2416, IC2405, IC2404, IC2399, IC2401, IC2403, IC2390, IC2406, IC2407, IC2398, IC2400, IC2397, IC2395, IC2384, IC2385, IC2374, IC2375, IC2376, IC2377, IC2365, IC2366, IC2378, IC2379, IC2364, IC2392, IC2393, IC2394, IC2396, IC2371, IC2372, IC2388, IC2389, IC2391, IC2381, IC2382, IC2383, IC2386, IC2387, IC2373, IC2359, IC2360, IC2361, IC2362, IC2363, IC2354, IC2355, IC2356, IC2357, IC2358, IC2353, IC2259, IC2351, IC2352, IC2256, IC2258, IC2350, IC2193, IC2347, IC2348, IC2349, IC2317, IC2279, IC2157, IC2295, IC2297, IC2339, IC2340, IC2341, IC2310, IC2343, IC2345, IC2342, IC2344, IC2323, IC2334, IC2336, IC2338, IC2320, IC2324, IC2333, IC2335, IC2337, IC2311, IC2316, IC2318, IC2319, IC2312, IC2313, IC2302, IC2303, IC2308, IC2309, IC2296, IC2300, IC2284, IC2287, IC2289, IC2276, IC2304, IC2305, IC2306, IC2307, IC2293, IC2299, IC1794, IC2298, IC2294, IC2301, IC2281, IC2282, IC2286, IC2288, IC2290, IC2292, IC2269, 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IC1434, IC1435, IC1436, IC1437, IC1442, IC1443, IC1432, IC1433, IC1438, IC1430, IC1439, IC1428, IC1418, IC1421, IC1422, IC1423, IC1419, IC1420, IC1414, IC1417, IC1394, IC1377, IC1380, IC1333, IC1403, IC1375, IC1401, IC1405, IC1407, IC1376, IC1402, IC1404, IC1410, IC1372, IC1374, IC1378, IC1373, IC1365, IC1360, IC1361, IC1358, IC1362, IC1363, IC1359, IC1313, IC1314, IC1356, IC1357, IC1353, IC1354, IC1355, IC1351, IC1352, IC1338, IC1339, IC1336, IC1337, IC1331, IC1334, IC1329, IC1335, IC1328, IC1330, IC1332, IC1312, IC1306, IC1310, IC1291, IC1300, IC1315, IC1316, IC1317, IC1319, IC1321, IC1309, IC1296, IC1297, IC1235, IC1213, IC1110, IC1307, IC1311, IC1326, IC1327, IC1320, IC1322, IC1325, IC1289, IC1290, IC1274, IC1234, IC1186, IC1179, IC1144, IC1140, IC1293, IC1272, IC1258, IC1298, IC1299, IC1295, IC1270, IC1246, IC1239, IC1292, IC1294, IC1269, IC1264, IC1251, IC1252, IC1271, IC1273, IC1259, IC1262, IC1263, IC1254, IC1256, IC1257, IC1253, IC1255, IC1242, IC1244, IC1245, IC1222, IC1226, IC1187, IC1221, IC1225, IC1243, IC1240, IC1228, IC1230, IC1207, IC1214, IC1220, IC1223, IC1227, IC1219, IC1233, IC1211, IC1212, IC1180, IC1178, IC1237, IC1229, IC1236, IC1205, IC1206, IC1218, IC1192, IC1160, IC1100, IC1204, IC1201, IC1208, IC1210, IC1200, IC1215, IC1193, IC1191, IC1209, IC1198, IC1199, IC1194, IC1197, IC1155, IC1188, IC1189, IC1183, IC1185, IC1153, IC1154, IC1161, IC1190, IC1184, IC1168, IC1169, IC1170, IC1162, IC1159, IC1181, IC1182, IC1176, IC1177, IC1171, IC1174, IC1175, IC1172, IC1173, IC1147, IC1148, IC1145, IC1146, IC1141, IC1142, IC1163, IC1164, IC1165, IC1166, IC1167, IC1156, IC1149, IC1157, IC1158, IC1139, IC1151, IC1152, IC1134, IC1133, IC1121, IC1150, IC1123, IC1143, IC1135, IC1136, IC1137, IC1138, IC1115, IC1120, IC1132, IC1111, IC1124, IC1112, IC1114, IC1106, IC1099, IC1116, IC1117, IC1119, IC1102, IC1105, IC1084, IC1085, IC1104, IC1108, IC1093, IC1095, IC1083, IC1103, IC1089, IC1094, IC1097, IC1088, IC1080, IC1086, IC1087, IC1081, IC1082, IC1077, IC1078, IC1079, IC1076, IC1058, IC1075, IC1074, IC1070, IC1071, IC1072, IC1073, IC1068, IC1069, IC1064, IC1065, IC1066, IC1067, IC1050, IC1060, IC1061, IC1062, IC1047, IC1051, IC1037, IC1038, IC1039, IC1041, IC1030, IC1056, IC1053, IC1055, IC1042, IC1044, IC1049, IC1052, IC1028, IC1040, IC1043, IC1046, IC1029, IC1036, IC1033, IC1035, IC1026, IC1027, IC1024, IC1025, IC1031, IC1032, IC1007, IC1008, IC1006, IC1019, IC1014, IC1017, IC1015, IC1002, IC1001, IC1004. 8. Product Code: 0042-0010-AU; GTIN: 00813502010930; Serial Numbers: IC5131, IC5130. 9. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC13013, IC13228, IC13190, IC13205, IC13223, IC13037, IC13027, IC13042, IC13038, IC13040, IC12955, IC12978, IC12984, IC12344, IC12334, IC12329, IC12328, IC12332, IC12326, IC12327, IC11746, IC12346, IC11162, IC11498, IC11485, IC9961, IC9972, IC9973, IC9801, IC9865, IC9867, IC8584, IC9832, IC9833, IC9834, IC9835, IC9804, IC9805, IC9783, IC9784, IC9799, IC9366, IC9356, IC9363, IC9369, IC9370, IC9371, IC9364, IC9368, IC9365, IC9349, IC9372, IC9299, IC9501, IC9320, IC9383, IC9181A, IC8476A, IC9005A, IC9006A, IC9093, IC9090, IC9008, IC9096, IC9031, IC9094, IC9095, IC9091, IC9027, IC8336, IC9028, IC9025, IC8861, IC8655, IC8813, IC8714, IC8775, IC8812, IC8765, IC8338, IC8761, IC8762, IC8340, IC8752, IC8763, IC8748, IC8750, IC8737, IC8739, IC8727, IC8723, IC8725, IC8726, IC8729, IC8644, IC8696, IC8691, IC8693, IC8683, IC8690, IC8692, IC8665, IC8751, IC8661, IC8662, IC8663, IC8664, IC8629, IC8625, IC5037, IC8646, IC8645, IC8647, IC8648, IC8649, IC8596, IC8608, IC8640, IC8641, IC8642, IC8639, IC8643, IC8591, IC8610, IC8630, IC8560, IC8621, IC8623, IC8600, IC8622, IC8588, IC8589, IC8586, IC8592, IC8488, IC8494, IC8503, IC8514, IC8499, IC8511, IC8512, IC8486, IC8439, IC8457, IC8482, IC8487, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8443, IC8444, IC8450, IC8419, IC8421, IC8422, IC8423, IC8424, IC8420, IC8425, IC8426, IC8427, IC8428, IC8404, IC8388, IC8387, IC8401, IC8402, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8344, IC8345, IC8342, IC8341, IC8343, IC8339, IC8337, IC8263, IC8261, IC8262, IC8259, IC8260, IC8252, IC8253, IC8257, IC8258, IC8256, IC8254, IC8255, IC8226, IC8222, IC8225, IC8220, IC8221, IC8218, IC8219, IC8217, IC8206, IC8204, IC8205, IC8202, IC8203, IC8201, IC8165, IC8159, IC8157, IC8158, IC8164, IC8162, IC8160, IC8161, IC8145, IC8146, IC8133, IC8134, IC8128, IC8130, IC8131, IC8132, IC8032, IC8126, IC8122, IC8123, IC8124, IC8125, IC8120, IC8121, IC8118, IC8119, IC8117, IC8075, IC8011, IC7965, IC7964, IC7958, IC7954, IC7957, IC7920, IC8073, IC8074, IC8069, IC8070, IC8067, IC8068, IC8071, IC8061, IC8064, IC8065, IC8063, IC7869, IC8059, IC8060, IC8062, IC8066, IC8056, IC8057, IC8058, IC8013, IC8012, IC7956, IC7953, IC7947, IC7943, IC7944, IC7937, IC7940, IC7939, IC7868, IC7867, IC7865, IC7866, IC7863, IC7864, IC7861, IC7862, IC7860, IC7829, IC7830, IC7827, IC7828, IC7826, IC7825, IC7823, IC7824, IC7821, IC7822, IC7799, IC7800, IC7794, IC7795, IC7796, IC7798, IC7792, IC7793, IC7740, IC7741, IC7738, IC7739, IC7710, IC7711, IC7762, IC7763, IC7764, IC7765, IC7637, IC7638, IC7639, IC7640, IC7636, IC7629, IC5038, IC7626, IC7627, IC7628, IC7625, IC7623, IC7624, IC7620, IC7621, IC7622, IC7526, IC7528, IC7524, IC7525, IC7523, IC7588, IC7589, IC7590, IC7275, IC7587, IC7460, IC7586, IC7464, IC7465, IC7462, IC7463, IC7459, IC7461, IC7458, IC7457, IC7361, IC7362, IC7363, IC7364, IC7359, IC7360, IC7358, IC7357, IC7356, IC7274, IC7272, IC7273, IC7271, IC7269, IC7270, IC7268, IC7235, IC7267, IC7161, IC6946, IC7234, IC7266, IC7232, IC7233, IC7158, IC7159, IC7160, IC7052, IC7226, IC7227, IC7156, IC7157, IC7050, IC7051, IC7048, IC7049, IC7047, IC7055, IC7053, IC7054, IC6987, IC6988, IC6986, IC6954, IC6955, IC6951, IC6952, IC6950, IC6703, IC6947, IC6948, IC6944, IC6945, IC6949, IC6875, IC6936, IC6874, IC6941, IC6872, IC6873, IC6937, IC6938, IC6939, IC6871, IC6940, IC6942, IC6869, IC6870, IC6758, IC6868, IC6784, IC5965, IC6792, IC6793, …

What the firm is doing

Abiomed notified consignees on about 05/14/2026 via letter titled "URGENT MEDICAL DEVICE RECALL (CORRECTION)." Consignees were made aware of the issue and potential risk and were informed that devices were not being removed, and hospital inventory can continue to be used. Specific, outlined scenarios were explained and that if they were to occur, that a console exchange is unnecessary as the phenomenon will recur on the exchange device. Abiomed is actively working on a software update to the AIC to address this issue. Consignees were instructed to complete and return the provided business reply form, forward the notice to anyone in each facility that needs to be informed, post copy of the notice in a visible area for awareness, and if any affected products have been forwarded to another facility, contact that facility and provide them with the notice.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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