United StatesWhat's being recalled
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.
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
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…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)