FDA recall, , High risk
Automated Impella Controller (AIC)
The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc. of Danvers, Massachusetts is recalling the Automated Impella Controller (AIC) for use with left heart support blood pumps due to a potential software error when used with left ventricular Impella devices. The recall, which began on May 14, 2026, affects 10,297 units distributed worldwide, including the US and numerous other countries. The FDA added the recall to its Enforcement Report and classified it on June 12, 2026, with the weekly enforcement report on June 24, 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 list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Automated Impella Controller (AIC), for use with left heart support blood pump.
- UDI-DI
- 00813502010886
- 00813502011272
- 00813502011289
- 00813502011418
- 00813502010428
- 00813502011296
- 00813502010022
- 00813502010930
- 00813502010961
- 00813502011425
- 00813502010978
- 00813502010985
- 00813502012958
- 00813502012217
- 00813502011814
- 00813502012972
- 00813502012484
- 00813502011401
- Affected units
- All products below with software versions 6
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Software 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
- 98853
- Recall number
- Z-2360-2026
- Quantity recalled
- 10,297 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
