Lower riskMedical device recall · FDA · Published March 1, 2021
Abiomed AIC Controller Software Update Recalled for Pump Recognition Issue
Abiomed recalls AIC controllers with software version 8.4 for potential pump recognition failure. Affected units require software update to prevent device malfunction.
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
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Contact the company
📍Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed AIC Controller Software Update Recalled for Pump Recognition Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63179-abiomed-aic-controller-software-update-recalled-for-pump-recognition-issue. Based on FDA recall #Z-1175-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1175-2024%22&limit=1).
The FDA announced on 2021-03-01 that Abiomed, Inc. voluntarily recalled Automated Impella Controllers due to a software issue where the pump was not recognized by the device. The recall affects units distributed nationwide in the U.S.
The recall addresses a retrospective reporting for the release of Technical Bulletin IMP-2643 regarding an AIC Version 8.5 Software Update. This update resolved an issue in version 8.4 where a pump was not recognized by the Automated Impella Controller.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since 2019-09-04. Other recent recalls of similar products include Abiomed Impella Optical Controller Recall: Purge Cassette Recognition Issues (2026-08-12), Abiomed Impella CP Set Recall: Introducer Sheath Leakage Risk (2026-06-11), and Abiomed Impella CP Set Recall: Risk of Blood Clots During Prolonged Use (2026-05-22).
How to tell if you have this one
Check for product codes 0042-0000-US, 0042-0010-US, or 0042-0040-US. The software version should be 8.4 or 8.4.1. The device is used with Impella Ventricular Support Systems.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Download and install the updated software version 8.5 from Abiomed's website or through the device's interface.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1175-2024 (March 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1175-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.