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.

Recall details

Manufacturer

Abiomed, Inc.

Distributor

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

Lot

1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Number: IC2687. 2. Product Code: 0042-0000-EU. GTIN: 00813502011289. Serial Numbers: 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 Numbers: IC1494, IC3785, IC3784. 4. Product Code: 0042-0000-US. GTIN: 00813502010022. Serial Numbers: 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,

Risk classification

Class II

Area (FDA)

device

Country

United States

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Questions about this recall