Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and correspondin…
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- 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
Show 4 more code fieldsShow fewer
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 detailsHide
Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3251-2026
- FDA device classification · OZDOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Abiomed, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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