Lower riskMedical device recall · FDA · Published February 16, 2026
Abiomed Automated Impella Controller Recall: Purge System Alarm Delay Risk
Abiomed recalls Automated Impella Controllers with software versions 8.2.2-8.5 that may delay 'Purge System Blocked' alarms when used with first-gen Impella 5.5 pumps. Affected units include specific product codes and serial numbers.
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
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Contact the company
📍Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed Automated Impella Controller Recall: Purge System Alarm Delay Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49974-abiomed-automated-impella-controller-recall-purge-system-alarm-delay-risk. Based on FDA recall #Z-1591-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2026%22&limit=1).
The FDA announced on Feb. 16, 2026, that Abiomed, Inc. is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm display when used with first generation Impella 5.5 pumps. The recall affects 62 units distributed internationally.
The hazard is the potential that the "Purge System Blocked" alarm display on the Automated Impella Controller could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
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 (2026-08-12), Abiomed Impella 5.5 Smart Assist Set Recall (2026-06-11), and Abiomed Impella CP Set Recall (2026-05-22). Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (2026-05-06), Philips Respironics Trilogy EV300 Ventilator Software Update Risk (2026-03-02), and Boston Scientific LUX-Dx Cardiac Monitor System Recall (2026-08-06).
How to tell if you have this one
Check for product codes starting with 0042-0000 or 0042-0010 with software versions 8.2.2 through 8.5. Affected units include specific serial numbers listed in the recall notice for each region.
Brand
Abiomed
Product
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Automated Impella Controller; versions 8.2.2 through 8.5 are affected.
How this recall unfolded
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
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-1591-2026 (February 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1591-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.