FDA recall, , High risk
Abiomed Impella Controllers
The Automated Impella Controller has alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing.
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 January 17, 2011, after identifying alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing in certain AIC consoles.
The recall also identifies improper alignment between the purge cassette and the motor drive in the AIC, which 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.
The recall covers 625 units distributed worldwide, including the US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and the United Kingdom.
The affected products include the Impella Controller, Packaged, with product codes 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, and 0042-0000-US. The FDA added the recall to its Enforcement Report on May 28, 2026, and classified it on the same date.
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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA;
Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU;
Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK;
Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US;
Product Code: 0042-0000-US.- UDI-DI
- 00813502011272
- 00813502011289
- 00813502011296
- 00813502010022
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, 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
- 98868
- Recall number
- Z-2238-2026
- Quantity recalled
- 625 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
In FDA's weekly enforcement report
Listed on Recall Canary
