Abiomed, Inc. 2025-08-06 Health critical FDA
Health · FDA · Recall #FDA-Z-2164-2025
Automated Impella Controller (AIC), used in left heart support blood pump, including the… Recall
Issued August 6, 2025 · Abiomed, Inc.
In August 2025, Abiomed, Inc. recalled the Automated Impella Controller (AIC), used in left heart support blood pump, including the…, 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
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
What you should do
- 1 Stop using Automated Impella Controller (AIC), used in left heart support blood pump, including the… 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.
Official remedy (Voluntary):
Recall details
- Brand
- Abiomed, Inc.
- Category
- Health
- Recall date
- August 6, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland,
- Recall number
- FDA-Z-2164-2025
- 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 691st Health recall we've logged in 2025.