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RecallWatchMedical Device Safety
Class IIOngoingZ-3251-2026

Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and correspondin…

Abiomed, Inc.Danvers, MA, United StatesReported Sep 30, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.

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) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Lot / code information

GTIN
00813502011272
Serial #
IC2687. 2. Product Code: 0042-0000-EU
GTIN
00813502011289
Serial #
IC3875, IC2380, IC2331, IC1721, IC1593, IC1587 — +337 moreShow all
IC3875, IC2380, IC2331, IC1721, IC1593, IC1587, IC4911, IC4231, IC4232, IC6844, IC2221, IC4628, IC6474, IC4502, IC1398, IC4055, IC3816, IC6810, IC6812, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6272, IC6149, IC6081, IC5681, IC5682, IC5517, IC5177, IC5169, IC5086, IC4892, IC4852, IC4848, IC4875, IC4851, IC4869, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4793, IC4795, IC4792, IC4794, IC4763, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4678, IC4677, IC4646, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4613, IC4614, IC4568, IC4610, IC4612, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4505, IC4506, IC4500, IC4469, IC4466, IC4467, IC4468, IC4446, IC4442, IC4443, IC4444, IC4445, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4328, IC4234, IC4363, IC4362, IC4356, IC4357, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4240, IC4241, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4217, IC4148, IC4149, IC4146, IC4147, IC4128, IC4129, IC4096, IC4097, IC4098, IC4083, IC4036, IC4037, IC3889, IC3833, IC3834, IC3859, IC3861, IC3862, IC3863, IC3885, IC3886, IC3884, IC3871, IC3872, IC3873, IC3832, IC3860, IC3831, IC3830, IC3815, IC3813, IC3814, IC3781, IC3782, IC3708, IC3717, IC3706, IC3707, IC3701, IC3703, IC3709, IC3667, IC3495, IC3492, IC3493, IC3659, IC3490, IC3660, IC3484, IC3485, IC3477, IC3472, IC3461, IC3467, IC3466, IC3468, IC3458, IC3459, IC3330, IC3460, IC3323, IC3313, IC3319, IC3327, IC3328, IC3303, IC3324, IC3321, IC3322, IC3310, IC3315, IC3314, IC3316, IC3304, IC3305, IC3302, IC3301, IC3300, IC3299, IC3297, IC3298, IC3290, IC3292, IC3289, IC3286, IC3288, IC3287, IC3180, IC3181, IC3178, IC3179, IC3145, IC3146, IC3144, IC3143, IC3149, IC3147, IC3148, IC3142, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3095, IC3096, IC3068, IC3067, IC3053, IC3054, IC3051, IC3052, IC3019, IC3017, IC2988, IC2987, IC2984, IC2985, IC2878, IC2960, IC2962, IC2964, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2824, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2708, IC2752, IC2670, IC2659, IC2658, IC2512, IC2556, IC2534, IC2491, IC2484, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2332, IC2412, IC2330, IC2411, IC2326, IC2327, IC2242, IC2325, IC2267, IC2268, IC2241, IC2266, IC2243, IC2204, IC2207, IC2240, IC2231, IC2173, IC2174, IC2171, IC2172, IC2095, IC2098, IC2096, IC2038, IC2039, IC2005, IC2006, IC1975, IC1976, IC1972, IC1973, IC1904, IC1907, IC1901, IC1881, IC1775, IC1780, IC1726, IC1761, IC1653, IC1411, IC1350, IC1383, IC1344, IC1345, IC1288, IC1275, IC1265. 3. Product Code: 0042-0000-UK
GTIN
00813502011296
Serial #
IC1494, IC3785, IC3784. 4. Product Code: 0042-0000-US
GTIN
00813502010022
Serial #
IC7027, IC7030, IC7032, IC6931, IC6930, IC6932 — +2684 moreShow all
IC7027, IC7030, IC7032, IC6931, IC6930, IC6932, IC6929, IC6928, IC6923, IC6919, IC6920, IC6921, IC6922, IC6898, IC6897, IC6917, IC6916, IC6889, IC6894, IC6895, IC6893, IC6901, IC6909, IC6911, IC6910, IC6912, IC6908, IC6913, IC6896, IC6899, IC6900, IC6842, IC6840, IC6836, IC6829, IC6831, IC6832, IC6811, IC6774, IC6864, IC6830, IC6801, IC6800, IC6798, IC6799, IC6847, IC6771, IC6772, IC6850, IC6851, IC6852, IC6854, IC6822, IC6820, IC6819, IC6818, IC6767, IC6754, IC6743, IC6729, IC6725, IC6724, IC6722, IC6682, IC6679, IC6685, IC6674, IC6668, IC6667, IC6647, IC6645, IC6646, IC6639, IC6630, IC6624, IC6625, IC6619, IC6616, IC6613, IC6612, IC6602, IC6601, IC6600, IC6571, IC6568, IC6566, IC6567, IC6565, IC6562, IC6547, IC6546, IC6524, IC6522, IC6518, IC6521, IC6514, IC6511, IC6505, IC6507, IC6504, IC6500, IC6501, IC6497, IC6498, IC6448, IC6495, IC6496, IC6428, IC6445, IC6484, IC6483, IC6438, IC6433, IC6479, IC6471, IC6472, IC6473, IC6470, IC6455, IC6454, IC6427, IC6426, IC6444, IC6450, IC6415, IC6412, IC6414, IC6411, IC6408, IC6409, IC6410, IC6404, IC6403, IC6402, IC6400, IC6401, IC6398, IC6399, IC6045, IC6391, IC6396, IC6392, IC6390, IC6393, IC6394, IC6361, IC6362, IC6368, IC6366, IC6367, IC6369, IC6365, IC6363, IC6364, IC6355, IC6356, IC6295, IC6288, IC6354, IC6352, IC6353, IC6349, IC6335, IC6346, IC6328, IC6329, IC6326, IC6327, IC6325, IC6323, IC6324, IC6319, IC6320, IC6317, IC6318, IC1250, IC6095, IC6271, IC6269, IC6255, IC6266, IC6267, IC6251, IC6250, IC6247, IC6248, IC6249, IC6244, IC6245, IC6246, IC6243, IC6242, IC6241, IC6239, IC6220, IC6218, IC6219, IC6217, IC6198, IC6199, IC6195, IC6196, IC6194, IC6192, IC6190, IC6191, IC6186, IC6187, IC6188, IC6189, IC6184, IC6185, IC6182, IC6183, IC6180, IC6181, IC6179, IC6177, IC6178, IC6176, IC6156, IC6161, IC6159, IC6160, IC6157, IC6158, IC6155, IC6154, IC6153, IC6152, IC6141, IC6144, IC6145, IC6146, IC6143, IC6133, IC6134, IC6136, IC6142, IC6140, IC6115, IC5565, IC6138, IC6137, IC6135, IC6129, IC6130, IC6131, IC6132, IC6128, IC6105, IC6106, IC6107, IC6103, IC6104, IC6100, IC6101, IC6102, IC6099, IC6097, IC6098, IC6092, IC6093, IC6094, IC6096, IC6077, IC6059, IC6063, IC6062, IC6061, IC6056, IC6057, IC6054, IC6055, IC6053, IC6051, IC6052, IC6041, IC6043, IC6044, IC6039, IC6040, IC6035, IC6036, IC6037, IC6034, IC6000, IC6031, IC6032, IC6028, IC6030, IC6033, IC6026, IC6027, IC6002, IC6003, IC6004, IC5992, IC5994, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, IC5981, IC5982, IC5979, IC5977, IC5978, IC5976, IC5954, IC5953, IC5952, IC5951, IC5950, IC5949, IC5947, IC5948, IC5946, IC5945, IC5943, IC5939, IC5940, IC5942, IC5906, IC5895, IC5893, IC5891, IC5892, IC5894, IC5890, IC5843, IC5889, IC5888, IC5881, IC5882, IC5883, IC5886, IC5887, IC5884, IC5885, IC5880, IC5778, IC5599, IC5776, IC5879, IC5874, IC5872, IC5873, IC5875, IC5878, IC5876, IC5877, IC5871, IC5870, IC5858, IC5855, IC5856, IC5857, IC5852, IC5848, IC5849, IC5850, IC5851, IC5847, IC5844, IC5845, IC5839, IC5840, IC5841, IC5842, IC5816, IC5827, IC5828, IC5823, IC5792, IC5793, IC5791, IC5790, IC5789, IC5787, IC5773, IC5770, IC5767, IC5766, IC5765, IC5763, IC5764, IC5760, IC5761, IC5747, IC5745, IC5746, IC5742, IC5743, IC5737, IC5738, IC5739, IC5736, IC5726, IC5723, IC5719, IC5711, IC5710, IC5707, IC5708, IC5704, IC5698, IC5697, IC5692, IC5691, IC5598, IC5663, IC5664, IC5676, IC5678, IC5619, IC5620, IC5564, IC5607, IC5650, IC5655, IC5647, IC5617, IC5615, IC5602, IC5562, IC5610, IC5604, IC5244, IC5552, IC5547, IC5548, IC5544, IC5540, IC5541, IC5539, IC5536, IC4556, IC5498, IC5499, IC5500, IC5503, IC5485, IC5480, IC5479, IC5475, IC4888, IC4889, IC4697, IC4573, IC4517, IC5469, IC5459, IC5470, IC5458, IC5457, IC4558, IC4498, IC4854, IC4935, IC5454, IC5092, IC4481, IC5453, IC5425, IC5420, IC4424, IC5395, IC5394, IC5417, IC5393, IC4584, IC5388, IC4554, IC4515, IC4426, IC5386, IC4922, IC4923, IC4827, IC5375, IC4427, IC4428, IC5374, IC4555, IC5373, IC5372, IC4862, IC4863, IC4574, IC4545, IC5371, IC4510, IC5003, IC4785, IC4786, IC4532, IC5365, IC5366, IC5367, IC5368, IC5369, IC5364, IC4544, IC4541, IC4686, IC4282, IC5345, IC5358, IC5359, IC5360, IC5361, IC5362, IC5363, IC4513, IC4283, IC5342, IC5343, IC5344, IC5340, IC5339, IC4477, IC5338, IC4550, IC4456, IC4415, IC4487, IC4423, IC4495, IC4378, IC4534, IC5337, IC4522, IC4486, IC4494, IC4461, IC4454, IC4431, IC4435, IC4436, IC4379, IC5336, IC5330, IC5335, IC5327, IC5328, IC5332, IC5329, IC5333, IC5334, IC4530, IC4453, IC4422, IC5320, IC5325, IC5324, IC5326, IC5322, IC5323, IC5321, IC4420, IC4336, IC5319, IC5318, IC4535, IC4490, IC4473, IC5313, IC5316, IC5317, IC5311, IC5312, IC5305, IC5304, IC5308, IC5306, IC5242, IC5303, IC5307, IC5310, IC5309, IC5299, IC5300, IC5301, IC5302, IC4472, IC4430, IC4434, IC5271, IC5297, IC5298, IC5293, IC5295, IC5296, IC4694, IC4543, IC4489, IC4474, IC5289, IC5287, IC5288, IC5275, IC5274, IC4526, IC5270, IC5269, IC5272, IC5273, IC4523, IC5266, IC5264, IC5265, IC5267, IC5268, IC4552, IC4540, IC4524, IC4520, IC4476, IC4455, IC4920, IC4804, IC4596, IC4539, IC4509, IC4460, IC5262, IC5263, IC4921, IC4458, IC4974, IC4980, IC4903, IC4485, IC4459, IC4457, IC5221, IC5222, IC5225, IC5172, IC5206, IC5170, IC5192, IC4981, IC4975, IC4696, IC4661, IC4665, IC4604, IC4551, IC4480, IC4432, IC4267, IC5190, IC5191, IC4899, IC4670, IC4536, IC4463, IC3644, IC3592, IC3594, IC4399, IC4408, IC4407, IC4403, IC3825, IC3350, IC3170, IC2869, IC2631, IC2634, IC2465, IC2487, IC1802, IC1830, IC1812, IC1425, IC3923, IC3254, IC2569, IC2580, IC1426, IC1261, IC5188, IC5189, IC4409, IC4402, IC4401, IC4274, IC3792, IC3348, IC3275, IC2781, IC2590, IC2579, IC2516, IC2075, IC1864, IC1814, IC1789, IC1705, IC1674, IC1431, IC1196, IC4828, IC4826, IC4499, IC5208, IC5209, IC3336, IC3272, IC3219, IC3250, IC2870, IC5204, IC5203, IC5207, IC5205, IC4970, IC4977, IC4900, IC4811, IC4674, IC4538, IC3117, IC1756, IC1704, IC4496, IC4497, IC5202, IC5200, IC5198, IC5199, IC5196, IC5197, IC5168, IC5150, IC5166, IC5167, IC5024, IC5155, IC5153, IC5154, IC5151, IC5152, IC5148, IC5149, …
GTIN
00813502010961
Serial #
IC6118, IC6119, IC5129, IC5042, IC5919, IC5282 — +260 moreShow all
IC6118, IC6119, IC5129, IC5042, IC5919, IC5282, IC6263, IC6261, IC5580, IC5592, IC5038, IC7156, IC6779, IC6776, IC6462, IC6418, IC6379, IC6416, IC6417, IC6383, IC6384, IC6377, IC6378, IC6344, IC6305, IC6336, IC6337, IC6304, IC6303, IC6342, IC6343, IC6302, IC6297, IC6298, IC6299, IC6282, IC6283, IC6278, IC6279, IC6277, IC6260, IC6259, IC6257, IC6258, IC6235, IC6256, IC6070, IC6231, IC6232, IC6234, IC6175, IC6226, IC6168, IC6169, IC6166, IC6167, IC6122, IC6123, IC6121, IC6174, IC6019, IC6172, IC6173, IC6014, IC6015, IC6171, IC6075, IC6116, IC6117, IC6120, IC6124, IC6073, IC6074, IC6069, IC6067, IC6068, IC6024, IC6025, IC6022, IC6023, IC6020, IC6021, IC5966, IC5967, IC6016, IC6017, IC5968, IC6012, IC5924, IC5923, IC5900, IC5963, IC5964, IC5918, IC5921, IC5905, IC5916, IC5922, IC5925, IC5903, IC5902, IC5920, IC5897, IC5898, IC5813, IC5814, IC5896, IC5811, IC5812, IC5809, IC5810, IC5808, IC5807, IC5806, IC5804, IC5805, IC5802, IC5803, IC5671, IC5672, IC5668, IC5669, IC5666, IC5667, IC5644, IC5645, IC5641, IC5643, IC5639, IC5640, IC5638, IC5642, IC5595, IC5635, IC5636, IC5533, IC5567, IC5628, IC5631, IC5629, IC5630, IC5632, IC5594, IC5633, IC5634, IC5627, IC5529, IC5585, IC5586, IC5583, IC5584, IC5570, IC5571, IC5569, IC5577, IC5566, IC5526, IC5532, IC5527, IC5528, IC5530, IC5531, IC5415, IC5412, IC5413, IC5410, IC5411, IC5408, IC5383, IC5407, IC5403, IC5404, IC5401, IC5402, IC5396, IC5398, IC5397, IC5378, IC5376, IC5377, IC5355, IC5281, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5283, IC5284, IC5285, IC5233, IC5234, IC5163, IC5164, IC5161, IC5162, IC5082, IC5157, IC5159, IC5160, IC5158, IC5145, IC5156, IC5140, IC5142, IC5143, IC5144, IC5141, IC5138, IC5139, IC5135, IC5136, IC5137, IC5133, IC5134, IC5132, IC4960, IC5127, IC5115, IC5126, IC5114, IC5101, IC5102, IC5103, IC5105, IC5104, IC5098, IC5106, IC5111, IC5100, IC5109, IC5110, IC5107, IC5108, IC5113, IC5112, IC5097, IC5099, IC5085, IC5096, IC5084, IC5080, IC5081, IC5078, IC5079, IC5076, IC5077, IC5044, IC5045, IC5040, IC5041, IC5039, IC4958, IC4959, IC4961, IC4957, IC4955, IC4953, IC4954, IC4952, IC4949, IC4950, IC4947, IC4948, IC4946. 6. Product Code: 0042-0010-US
Show 4 more code fields
GTIN
00813502010985
Serial #
IC7251, IC7037, IC7023, IC7021, IC6996, IC6998, IC6999, IC6975, IC6997, IC6974, IC6972, IC6963, IC6964, IC6959, IC6958, IC6957, IC5971, IC5970. 7. Product Code: 0042-0040-US
GTIN
00813502011401
Serial #
IC7186

What the firm is doing

No customer notifications were sent. The retrospectively reported recall does not currently affect any Automated Impella Controllers (AICs) in the field pending the correction. The hardware update was implemented to AICs in the field through servicing to address potential safety concerns.

DistributionShow details

Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

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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