Automated Impella Controller (AIC) with the below product descriptions and corresponding… Recall
Issued June 3, 2026 · Abiomed, Inc.
In June 2026, Abiomed, Inc. recalled the Automated Impella Controller (AIC) with the below product descriptions and corresponding…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
What you should do
- 1 Stop using Automated Impella Controller (AIC) with the below product descriptions and corresponding… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abiomed, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Abiomed, Inc.
- Category
- Health
- Recall date
- June 3, 2026
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arab
- Recall number
- FDA-Z-2238-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Abiomed, Inc. has 9 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.