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RecallWatchMedical Device Safety
Class IOngoingZ-2164-2025

Abiomed, Inc. recalls Automated Impella Controller (AIC)

Abiomed, Inc.Danvers, MA, United StatesReported Aug 6, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

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), used in left heart support blood pump, including the following: 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, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.

Lot / code information

GTIN
813502010886
Serial #
IC7849, IC7850, IC7287, IC7288, IC7289, IC7290 — +21 moreShow all
IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6526, IC6527, IC6528, IC6529, IC6530, IC6531, IC5622, IC5677, IC5752, IC5836, IC5341, IC5521, IC5522, IC5523, IC5524, IC5525, IC5237, IC5216, IC5217, IC5236, IC5238. 2. Product Code: 0042-0000-CA
GTIN
813502011272
Serial #
IC9416, IC9414, IC9415, IC9413, IC8283, IC7695 — +45 moreShow all
IC9416, IC9414, IC9415, IC9413, IC8283, IC7695, IC7716, IC7694, IC6633, IC6634, IC6635, IC6636, IC6082, IC6083, IC5821, IC5824, IC5680, IC5034, IC5050, IC4944, IC4945, IC3802, IC3803, IC3661, IC3662, IC2686, IC2687, IC2369, IC2370, IC2033, IC2035, IC2032, IC2034, IC1911, IC1912, IC1913, IC1790, IC1791, IC1715, IC1769, IC1664, IC1665, IC1595, IC1598, IC1572, IC1543, IC1544, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU
GTIN
813502011289
Serial #
IC7809, IC7717, IC7718, IC7719, IC7720, IC7721 — +979 moreShow all
IC7809, IC7717, IC7718, IC7719, IC7720, IC7721, IC7748, IC7674, IC7675, IC7686, IC7687, IC7688, IC7689, IC7690, IC7691, IC7692, IC7693, IC7653, IC7654, IC7655, IC7666, IC7667, IC7646, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7613, IC7614, IC7615, IC7421, IC7576, IC7577, IC7578, IC7579, IC7580, IC7581, IC7582, IC7583, IC7584, IC7455, IC7452, IC7453, IC7454, IC7378, IC7388, IC7389, IC7390, IC7392, IC7393, IC7394, IC7407, IC7395, IC7406, IC7263, IC7264, IC7265, IC7286, IC7258, IC7259, IC7260, IC7261, IC7262, IC7087, IC7092, IC7093, IC7094, IC7095, IC7096, IC7097, IC7098, IC7099, IC7100, IC7075, IC7076, IC7077, IC7078, IC6843, IC6844, IC6845, IC6876, IC6877, IC6878, IC6879, IC6880, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6810, IC6812, IC6813, IC6814, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6710, IC6711, IC6712, IC6713, IC6714, IC6715, IC6716, IC6717, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6708, IC6709, IC6587, IC6588, IC6589, IC6590, IC6591, IC6592, IC6593, IC6594, IC6595, IC6577, IC6578, IC6579, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6510, IC6449, IC6469, IC6474, IC6487, IC6488, IC6489, IC6437, IC6439, IC6440, IC6441, IC6443, IC6431, IC6432, IC6435, IC6436, IC6434, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6270, IC6331, IC6205, IC6214, IC6216, IC6293, IC6294, IC6272, IC6273, IC6274, IC6275, IC6223, IC6224, IC6225, IC6236, IC6164, IC6165, IC6147, IC6148, IC6149, IC6150, IC6151, IC6078, IC6081, IC6079, IC6080, IC6064, IC6076, IC5817, IC5818, IC5774, IC5775, IC5777, IC5779, IC5781, IC5780, IC5754, IC5755, IC5756, IC5757, IC5611, IC5714, IC5715, IC5716, IC5717, IC5722, IC5681, IC5682, IC5683, IC5684, IC5685, IC5686, IC5688, IC5687, IC5559, IC5560, IC5558, IC5517, IC5518, IC5519, IC5520, IC5495, IC5496, IC5487, IC5488, IC5489, IC5490, IC5491, IC5492, IC5493, IC5494, IC5476, IC5477, IC5357, IC5465, IC5466, IC5467, IC5460, IC5461, IC5462, IC5463, IC5464, IC5440, IC5441, IC5442, IC5443, IC5433, IC5434, IC5435, IC5436, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5251, IC5252, IC5193, IC5194, IC5195, IC5210, IC5212, IC5169, IC5171, IC5173, IC5174, IC5175, IC5176, IC5177, IC5178, IC5051, IC5053, IC5075, IC5086, IC5087, IC5088, IC5046, IC5047, IC5048, IC5049, IC5057, IC5055, IC4973, IC5007, IC5008, IC5009, IC4984, IC4986, IC4987, IC4988, IC4850, IC4928, IC4929, IC4930, IC4931, IC4932, IC4933, IC4934, IC4911, IC4912, IC4913, IC4914, IC4915, IC4916, IC4917, IC4845, IC4846, IC4833, IC4834, IC4835, IC4836, IC4837, IC4839, IC4840, IC4823, IC4824, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4790, IC4791, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4781, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4723, IC4724, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4725, IC4727, IC4728, IC4729, IC4677, IC4678, IC4679, IC4680, IC4681, IC4682, IC4645, IC4646, IC4647, IC4648, IC4649, IC4656, IC4657, IC4658, IC4585, IC4630, IC4631, IC4632, IC4633, IC4634, IC4635, IC4636, IC4623, IC4624, IC4626, IC4627, IC4628, IC4629, IC4609, IC4610, IC4611, IC4612, IC4613, IC4614, IC4594, IC4595, IC4597, IC4598, IC4557, IC4565, IC4566, IC4567, IC4568, IC4569, IC4559, IC4560, IC4561, IC4562, IC4563, IC4564, IC4500, IC4501, IC4502, IC4503, IC4505, IC4506, IC4507, IC4508, IC4464, IC4465, IC4466, IC4467, IC4468, IC4469, IC4470, IC4471, IC4442, IC4443, IC4444, IC4445, IC4446, IC4365, IC4366, IC4367, IC4370, IC4371, IC4356, IC4357, IC4358, IC4359, IC4360, IC4361, IC4362, IC4363, IC4322, IC4323, IC4324, IC4325, IC4326, IC4328, IC4329, IC4251, IC4252, IC4253, IC4254, IC4255, IC4256, IC4257, IC4258, IC4235, IC4236, IC4237, IC4238, IC4241, IC4242, IC4240, IC4233, IC4227, IC4228, IC4229, IC4230, IC4231, IC4232, IC4234, IC4217, IC4218, IC4207, IC4208, IC4209, IC4210, IC4211, IC4212, IC4175, IC4146, IC4147, IC4148, IC4149, IC4150, IC4151, IC4152, IC4153, IC4128, IC4129, IC4096, IC4097, IC4098, IC4099, IC4100, IC4081, IC4083, IC4068, IC4069, IC4054, IC4055, IC4036, IC4037, IC4033, IC4034, IC4035, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3885, IC3886, IC3887, IC3888, IC3889, IC3891, IC3884, IC3890, IC3868, IC3869, IC3870, IC3871, IC3872, IC3874, IC3875, IC3873, IC3859, IC3861, IC3862, IC3863, IC3864, IC3866, IC3867, IC3860, IC3828, IC3829, IC3830, IC3831, IC3833, IC3834, IC3832, IC3815, IC3816, IC3817, IC3818, IC3812, IC3813, IC3814, IC3777, IC3778, IC3780, IC3781, IC3782, IC3783, IC3776, IC3779, IC3717, IC3724, IC3718, IC3719, IC3720, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3704, IC3705, IC3696, IC3697, IC3698, IC3699, IC3700, IC3702, IC3657, IC3667, IC3668, IC3669, IC3670, IC3671, IC3672, IC3673, IC3663, IC3664, IC3665, IC3666, IC3492, IC3493, IC3495, IC3656, IC3658, IC3659, IC3494, IC3660, IC3477, IC3485, IC3486, IC3487, IC3488, IC3489, IC3491, IC3490, IC3484, IC3466, IC3467, IC3468, IC3469, IC3470, IC3471, IC3472, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3313, IC3319, IC3323, IC3329, IC3330, IC3331, IC3332, IC3327, IC3328, IC3314, IC3315, IC3316, IC3317, IC3318, IC3321, IC3322, IC3324, IC3304, IC3305, IC3306, IC3307, IC3308, IC3309, IC3310, IC3311, IC3296, IC3297, IC3298, IC3299, IC3300, IC3303, IC3301, IC3302, IC3286, IC3287, IC3288, IC3289, IC3290, IC3291, IC3292, IC3184, IC3178, IC3179, IC3180, IC3181, IC3182, IC3183, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3127, IC3128, IC3129, IC3130, IC3133, IC3134, IC3131, IC3132, IC3095, IC3096, IC3097, IC3098, IC3100, IC3101, IC3099, IC3102, IC3067, IC3068, IC3069, IC3070, IC3048, IC3049, IC3051, IC3052, IC3053, IC3054, IC3050, IC3015, IC3016, IC3017, IC3018, IC3019, IC3020, IC3021, IC3022, IC2996, IC2997, IC2984, IC2985, IC2987, IC2988, IC2989, IC2960, IC2961, IC2962, IC2963, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2878, IC2855, IC2856, IC2858, IC2859, IC2862, IC2860, IC2861, IC2835, IC2836, IC2837, IC2838, IC2823, IC2824, IC2825, IC2826, IC2828, IC2829, IC2830, IC2827, IC2763, …
GTIN
813502011289
Serial #
IC7810, IC6065, IC4910, IC4901, IC4891, IC4892 — +42 moreShow all
IC7810, IC6065, IC4910, IC4901, IC4891, IC4892, IC4875, IC4876, IC4879, IC4880, IC4881, IC4874, IC4877, IC4878, IC4867, IC4868, IC4869, IC4870, IC4871, IC4872, IC4873, IC4866, IC4855, IC4847, IC4848, IC4849, IC4851, IC4852, IC4853, IC4838, IC4622, IC4625, IC4364, IC4239, IC4032, IC3827, IC3320, IC2986, IC2857, IC2176, IC1906, IC1762, IC1520, IC1521, IC1487, IC1399, IC1303, IC1011. 5. Product Code: 0042-0000-IN
GTIN
813502011418
Serial #
IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6475, IC6476, IC6477, IC6478, IC6139, IC6252, IC6253, IC6254. 6. Product Code: 0042-0000-JP
Show 10 more code fields
GTIN
813502010428
Serial #
IC8276, IC8277, IC8278, IC8279, IC8280, IC8281 — +313 moreShow all
IC8276, IC8277, IC8278, IC8279, IC8280, IC8281, IC8282, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8047, IC8048, IC8049, IC8050, IC8051, IC8052, IC8053, IC8054, IC8055, IC8076, IC8077, IC8085, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7928, IC7929, IC7902, IC7903, IC7904, IC7905, IC7926, IC7927, IC7899, IC7900, IC7901, IC7852, IC7853, IC7854, IC7855, IC7896, IC7897, IC7898, IC7851, IC7812, IC7813, IC7814, IC7815, IC7846, IC7808, IC7811, IC7784, IC7785, IC7806, IC7779, IC7780, IC7781, IC7782, IC7783, IC7746, IC7747, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7593, IC7594, IC7595, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7433, IC7434, IC7435, IC7439, IC7440, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7291, IC7293, IC7294, IC7295, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6468, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6202, IC6203, IC6204, IC6210, IC6211, IC6212, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6091, IC6046, IC6047, IC6048, IC6049, IC5929, IC5930, IC5935, IC5936, IC5937, IC5938, IC5928, IC5864, IC5865, IC5866, IC5867, IC5868, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, 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. 7. Product Code: 0042-0000-JP-L
GTIN
813502010428
Serial #
IC7448, IC7449, IC7391, IC7432, IC7436, IC7437 — +34 moreShow all
IC7448, IC7449, IC7391, IC7432, IC7436, IC7437, IC7438, IC7418, IC7419, IC7428, IC7292, IC7101, IC7086, IC7088, IC6881, IC6884, IC6655, IC6608, IC6609, IC6539, IC6532, IC6493, IC6494, IC6207, IC6209, IC5931, IC5932, IC5934, IC5869, IC5730, IC5508, IC5509, IC5513, IC5514, IC5258, IC5246, IC5029, IC5030, IC5031, IC4730. 8. Product Code: 0042-0000-UK
GTIN
813502011296
Serial #
IC7847, IC7848, IC7668, IC7669, IC7670, IC7671 — +153 moreShow all
IC7847, IC7848, IC7668, IC7669, IC7670, IC7671, IC7585, IC7591, IC7444, IC7445, IC7446, IC7447, IC7441, IC7442, IC7443, IC7072, IC7069, IC7070, IC7071, IC7073, IC7074, IC7056, IC7057, IC6934, IC6925, IC6924, IC6638, IC6669, IC6670, IC6671, IC6583, IC6584, IC6585, IC6586, IC6537, IC6538, IC6542, IC6543, IC6540, IC6286, IC6287, IC6289, IC6290, IC6291, IC6292, IC6001, IC5995, IC5996, IC5997, IC5998, IC5999, IC5914, IC5915, IC5911, IC5912, IC5926, IC5927, IC5910, IC5830, IC5831, IC5832, IC5833, IC5553, IC5554, IC5555, IC5557, IC5253, IC5254, IC5180, IC5211, IC5213, IC5247, IC5240, IC5218, IC5219, IC5220, IC5214, IC5215, IC5179, IC5181, IC5182, IC5184, IC4926, IC4927, IC4856, IC4857, IC4841, IC4842, IC4843, IC4844, IC4739, IC4741, IC4721, IC4722, IC4676, IC4675, IC4599, IC4600, IC4525, IC4438, IC4439, IC4440, IC4441, IC4330, IC4331, IC4082, IC4166, IC3784, IC3785, IC3674, IC3675, IC3475, IC3474, IC3464, IC3465, IC3333, IC3334, IC3325, IC3326, IC3312, IC3293, IC3294, IC3295, IC3174, IC2871, IC2872, IC2704, IC2705, IC2706, IC2707, IC2492, IC2493, IC2497, IC2496, IC2367, IC2368, IC2277, IC2278, IC2023, IC2024, IC2025, IC1909, IC1910, IC1868, IC1869, IC1792, IC1573, IC1581, IC1582, IC1583, IC1545, IC1542, IC1519, IC1494, IC1387, IC1388, IC1389, IC1391, IC1392. 9. Product Code: 0042-0000-UK-L
GTIN
813502011296
Serial #
IC7776, IC7777, IC7778, IC7592, IC3175, IC1576, IC1493. 10. Product Code: 0042-0000-US
GTIN
813502010022
Serial #
IC7919, IC7922, IC7028, IC7030, IC7032, IC6976 — +2325 moreShow all
IC7919, IC7922, IC7028, IC7030, IC7032, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6982, IC6983, IC6984, IC7026, IC7027, IC6926, IC6927, IC6928, IC6929, IC6930, IC6931, IC6932, IC6933, IC6935, IC6914, IC6915, IC6916, IC6917, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6904, IC6905, IC6906, IC6907, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6889, IC6893, IC6894, IC6895, IC6896, IC6897, IC6898, IC6899, IC6900, IC6901, IC6833, IC6836, IC6837, IC6838, IC6839, IC6840, IC6841, IC6842, IC6834, IC6835, IC6811, IC6829, IC6831, IC6832, IC6830, IC6815, IC6826, IC6827, IC6828, IC6796, IC6797, IC6798, IC6799, IC6800, IC6801, IC6802, IC6803, IC6864, IC6865, IC6850, IC6851, IC6852, IC6853, IC6854, IC6824, IC6847, IC6848, IC6849, IC6825, IC6846, IC6774, IC6775, IC6816, IC6817, IC6818, IC6819, IC6820, IC6822, IC6823, IC6732, IC6753, IC6754, IC6755, IC6766, IC6767, IC6768, IC6769, IC6770, IC6771, IC6772, IC6773, IC6743, IC6744, IC6726, IC6727, IC6729, IC6730, IC6731, IC6733, IC6734, IC6735, IC6736, IC6737, IC6718, IC6719, IC6720, IC6721, IC6722, IC6723, IC6724, IC6725, IC6678, IC6679, IC6680, IC6681, IC6682, IC6683, IC6684, IC6685, IC6686, IC6687, IC6672, IC6674, IC6675, IC6676, IC6677, IC6673, IC6663, IC6664, IC6665, IC6666, IC6667, IC6668, IC6639, IC6640, IC6641, IC6643, IC6644, IC6645, IC6646, IC6647, IC6648, IC6649, IC6637, IC6624, IC6625, IC6626, IC6627, IC6628, IC6629, IC6630, IC6631, IC6632, IC6611, IC6612, IC6613, IC6614, IC6615, IC6616, IC6617, IC6618, IC6619, IC6620, IC6621, IC6622, IC6623, IC6515, IC6598, IC6599, IC6600, IC6601, IC6602, IC6603, IC6604, IC6596, IC6597, IC6562, IC6563, IC6564, IC6565, IC6566, IC6567, IC6568, IC6569, IC6570, IC6571, IC6572, IC6573, IC6574, IC6575, IC6576, IC6557, IC6558, IC6559, IC6560, IC6561, IC6544, IC6545, IC6546, IC6547, IC6511, IC6512, IC6513, IC6514, IC6516, IC6517, IC6518, IC6520, IC6521, IC6522, IC6523, IC6524, IC6525, IC6500, IC6502, IC6503, IC6504, IC6505, IC6506, IC6507, IC6508, IC6509, IC6495, IC6496, IC6497, 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IC5742, IC5743, IC5718, IC5719, IC5723, IC5724, IC5725, IC5726, IC5720, IC5721, IC5704, IC5705, IC5706, IC5707, IC5708, IC5709, IC5710, IC5711, IC5712, IC5713, IC5701, IC5702, IC5703, IC5692, IC5693, IC5694, IC5695, IC5696, IC5697, IC5698, IC5699, IC5609, IC5690, IC5691, IC5599, IC5621, IC5623, IC5663, IC5664, IC5676, IC5678, IC5661, IC5662, IC5598, IC5549, IC5605, IC5607, IC5608, IC5619, IC5620, IC5624, IC5625, IC5564, IC5617, IC5647, IC5648, IC5649, IC5650, IC5655, IC5562, IC5596, IC5602, IC5603, IC5613, IC5614, IC5615, IC5616, IC5561, IC5597, IC5600, IC5601, IC5604, IC5606, IC5610, IC5612, IC5536, IC5537, IC5538, IC5539, IC5540, IC5541, IC5542, IC5543, IC5544, IC5545, IC5546, IC5547, IC5548, IC5550, IC5551, IC5552, IC5498, IC5499, IC5501, IC5502, IC5503, IC5504, IC5500, IC5497, IC5244, IC5479, IC5480, IC5481, IC5482, IC5483, IC5484, IC5485, IC5486, IC5468, IC5469, IC5470, IC5471, IC5472, IC5473, IC5474, IC5475, IC5453, IC5454, IC5455, IC5456, IC5457, IC5458, IC5459, IC5425, IC5393, …
Additional code information

846, IC2840, IC2841, IC2831, IC2832, IC2833, IC2834, IC2815, IC2816, IC2817, IC2818, IC2820, IC2821, IC2822, IC2807, IC2808, IC2809, IC2810, IC2811, IC2812, IC2813, IC2814, IC2764, IC2792, IC2793, IC2794, IC2795, IC2796, IC2797, IC2798, IC2799, IC2800, IC2801, IC2802, IC2803, IC2804, IC2805, IC2806, IC2784, IC2785, IC2786, IC2787, IC2788, IC2789, IC2790, IC2791, IC2776, IC2777, IC2778, IC2779, IC2780, IC2781, IC2782, IC2783, IC2759, IC2760, IC2761, IC2762, IC2768, IC2769, IC2770, IC2771, IC2772, IC2773, IC2774, IC2775, IC2740, IC2741, IC2742, IC2743, IC2744, IC2745, IC2746, IC2739, IC2730, IC2732, IC2733, IC2734, IC2735, IC2736, IC2737, IC2738, IC2747, IC2748, IC2749, IC2819, IC2722, IC2723, IC2724, IC2725, IC2726, IC2727, IC2728, IC2729, IC2717, IC2718, IC2719, IC2721, IC2720, IC2713, IC2714, IC2715, IC2716, IC2689, IC2690, IC2693, IC2694, IC2695, IC2696, IC2697, IC2698, IC2699, IC2700, IC2701, IC2702, IC2703, IC2691, IC2692, IC2675, IC2680, IC2681, IC2682, IC2684, IC2621, IC2650, 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IC2198, IC2200, IC2201, IC2202, IC2203, IC2208, IC2209, IC2210, IC2199, IC2185, IC2186, IC2187, IC2188, IC2189, IC2190, IC2191, IC2192, IC2193, IC2194, IC2168, IC2169, IC2170, IC2180, IC2181, IC2182, IC2183, IC2184, IC2148, IC2149, IC2150, IC2152, IC2153, IC2155, IC2157, IC2158, IC2159, IC2160, IC2161, IC2162, IC2163, IC2164, IC2165, IC2166, IC2167, IC2154, IC1947, IC2138, IC2140, IC2146, IC2147, IC1970, IC2134, IC2135, IC2136, IC2137, IC2139, IC2141, IC2142, IC2103, IC2131, IC2132, IC2133, IC2124, IC2125, IC2126, IC2127, IC2128, IC2129, IC2130, IC2114, IC2115, IC2116, IC2117, IC2118, IC2119, IC2120, IC2121, IC2122, IC2104, IC2105, IC2106, IC2107, IC2108, IC2109, IC2110, IC2111, IC2112, IC2113, IC2089, IC2090, IC2091, IC2092, IC2093, IC2094, IC2087, IC2088, IC2079, IC2080, IC2081, IC2082, IC2083, IC2084, IC2085, IC2086, IC2072, IC2073, IC2074, IC2075, IC2076, IC2077, IC2078, IC2056, IC2057, IC2058, IC2059, IC2060, IC2061, IC2062, IC2063, IC2064, IC2065, IC2066, IC2067, IC2068, IC2070, 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IC1571, IC1550, IC1551, IC1552, IC1553, IC1554, IC1555, IC1556, IC1557, IC1526, IC1527, IC1528, IC1529, IC1530, IC1531, IC1532, IC1533, IC1534, IC1535, IC1536, IC1537, IC1538, IC1539, IC1540, IC1541, IC1497, IC1498, IC1499, IC1500, IC1501, IC1502, IC1503, IC1504, IC1505, IC1506, IC1507, IC1508, IC1509, IC1510, IC1512, IC1513, IC1514, IC1515, IC1516, IC1517, IC1518, IC1511, IC1486, IC1495, IC1496, IC1489, IC1491, IC1492, IC1476, IC1477, IC1478, IC1479, IC1483, IC1484, IC1485, IC1451, IC1452, IC1453, IC1454, IC1455, IC1456, IC1457, IC1458, IC1459, IC1460, IC1461, IC1462, IC1463, IC1464, IC1465, IC1466, IC1467, IC1469, IC1470, IC1471, IC1472, IC1473, IC1474, IC1475, IC1368, IC1444, IC1445, IC1446, IC1448, IC1449, IC1450, IC1432, IC1433, IC1434, IC1435, IC1436, IC1437, IC1438, IC1439, IC1440, IC1441, IC1442, IC1443, IC1424, IC1425, IC1426, IC1427, IC1428, IC1429, IC1430, IC1431, IC1418, IC1419, IC1420, IC1421, IC1422, IC1423, IC1412, IC1414, IC1417, IC1394, IC1400, IC1401, IC1402, IC1403, IC1404, IC1405, IC1406, IC1407, IC1408, IC1409, IC1410, IC1390, IC1382, IC1372, IC1373, IC1374, IC1375, IC1376, IC1377, IC1378, IC1379, IC1380, IC1359, IC1360, IC1361, IC1362, IC1363, IC1364, IC1365, IC1351, IC1352, IC1353, IC1354, IC1355, IC1356, IC1357, IC1358, IC1334, IC1337, IC1338, IC1339, IC1342, IC1329, IC1333, IC1335, IC1336, IC1326, IC1327, IC1328, IC1330, IC1331, IC1332, IC1312, IC1313, IC1314, IC1315, IC1316, IC1317, IC1319, IC1320, IC1321, IC1322, IC1325, IC1306, IC1307, IC1309, IC1310, IC1311, IC1289, IC1290, IC1291, IC1292, IC1293, IC1294, IC1295, IC1296, IC1297, IC1298, IC1299, IC1300, IC1270, IC1271, IC1272, IC1273, IC1274, IC1269, IC1259, IC1261, IC1262, IC1263, IC1264, IC1246, IC1247, IC1250, IC1251, IC1252, IC1253, IC1254, IC1255, IC1256, IC1257, IC1258, IC1242, IC1243, IC1244, IC1245, IC1239, IC1240, IC1237, IC1238, IC1228, IC1229, IC1230, IC1233, IC1234, IC1235, IC1236, IC1231, IC1204, IC1205, IC1206, IC1207, IC1203, IC1200, IC1201, IC1202, IC1208, IC1209, IC1210, IC1211, IC1212, IC1213, IC1214, IC1215, IC1220, IC1221, IC1222, IC1223, IC1225, IC1226, IC1227, IC1224, IC1198, IC1199, IC1194, IC1196, IC1197, IC1218, IC1219, IC1192, IC1193, IC1161, IC1187, IC1188, IC1189, IC1190, IC1191, IC1155, IC1183, IC1184, IC1185, IC1186, IC1179, IC1180, IC1181, IC1182, IC1160, IC1176, IC1177, IC1178, IC1168, IC1169, IC1170, IC1171, IC1172, IC1173, IC1174, IC1175, IC1162, IC1163, IC1164, IC1165, IC1166, IC1167, IC1156, IC1159, IC1157, IC1158, IC1153, IC1154, IC1151, IC1152, IC1150, IC1145, IC1146, IC1147, IC1148, IC1149, IC1121, IC1123, IC1122, IC1143, IC1144, IC1139, IC1140, IC1141, IC1142, IC1134, IC1135, IC1136, IC1137, IC1138, IC1124, IC1132, IC1133, IC1110, IC1111, IC1112, IC1114, IC1115, IC1116, IC1117, IC1119, IC1120, IC1102, IC1103, IC1104, IC1105, IC1106, IC1108, IC1089, IC1093, IC1094, IC1095, IC1097, IC1099, IC1100, IC1096, IC1098, IC1081, IC1082, IC1083, IC1084, IC1085, IC1086, IC1087, IC1088, IC1080, IC1077, IC1078, IC1079, IC1076, IC1058, IC1075, IC1068, IC1069, IC1070, IC1071, IC1072, IC1073, IC1074, IC1064, IC1065, IC1066, IC1067, IC1050, IC1060, IC1061, IC1062, IC1047, IC1051, IC1030, IC1056, IC1057, IC1040, IC1052, IC1053, IC1055, IC1037, IC1038, IC1039, IC1041, IC1042, IC1043, IC1044, IC1046, IC1049, IC1036, IC1031, IC1032, IC1033, IC1035, IC1026, IC1027, IC1028, IC1029, IC1024, IC1025, IC1019, IC1017, IC1015, IC1014, IC1009, IC1007, IC1008, IC1005, IC1006, IC1001, IC1002, IC1004. 11. Product Code: 0042-0000-US-L; GTIN Number: 813502010022; Serial Numbers: IC1370, IC5021, IC6902, IC6903, IC6890, IC6891, IC6892, IC6821, IC6113, IC6114, IC6126, IC6127, IC6108, IC6109, IC6110, IC6111, IC6112, IC5913, IC5834, IC5835, IC5837, IC5782, IC5783, IC5784, IC5785, IC5786, IC5618, IC5744, IC5426, IC5427, IC5428, IC5429, IC5430, IC5431, IC5432, IC5065, IC5248, IC5249, IC5250, IC5121, IC5186, IC5187, IC5016, IC5010, IC5011, IC5012, IC5013, IC5014, IC4742, IC4743, IC4745, IC4746, IC4747, IC4592, IC4586, IC4587, IC4589, IC4590, IC4553, IC433 …

What the firm is doing

Initially Abiomed posted their recall notification on their website, HeartRecover.com on 06/23/2025. Consignees were also notified on 06/25/2025 via letter. Consignees were advised that devices were not being removed. They were advised to have a back-up Automated Impella Controller (AIC) available in the event of a device failure and were provided work around instruction for console-to-console transfer and case starts. Additionally, consignees were instructed to forward the notification to all pertinent personnel and customers if further distributed and complete and return the business response form provided.

DistributionShow details

Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and 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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