FDA Device recall Z-3251-2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA

FDA Device
Class II
ongoing
Published 2026-09-30

On 2026-09-30 the FDA classified a Class II recall of Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA by Abiomed, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3251-2026
Classification	Class II
Status	ongoing
Initiated	2019-02-19
Published	2026-09-30
Last updated	2026-10-06 05:30 UTC
Company	Abiomed
Distribution	US

Product

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.

Reason

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.

Identifiers

code_info	1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Number: IC2687. 2. Product Code: 0042-0000-EU. GTIN: 0081… 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, IC444

code_info

1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Number: IC2687. 2. Product Code: 0042-0000-EU. GTIN: 0081…

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, IC444

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.

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Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3251-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.