FDA recall, , High risk
Automated Impella Controller (AIC)
The Automated Impella Controller may interrupt motor control, have startup issues, or boot up improperly.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc., of Danvers, Massachusetts, began a recall of the Automated Impella Controller (AIC) on April 20, 2026, after a retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. The recall involves 91 units distributed in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom.
The hardware updates have been implemented through Abiomed's servicing process; therefore, AICs that have not received service are pending these updates. The FDA added the recall to its Enforcement Report and classified it on May 22, 2026, with the weekly enforcement report dated June 3, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and product code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Automated Impella Controller (AIC)
- UDI-DI
- 00813502010022
- Product code
- 0042-0000-US
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Connecticut, Florida, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Dakota, New York, Ohio, Pennsylvania, Texas, Wyoming and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98770
- Recall number
- Z-2211-2026
- Quantity recalled
- 91 units
All recalls from Abiomed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
