Abiomed Impella Controllers
The Automated Impella Controller may have purge cassette recognition issues due to a purge flag component failure.
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
2 photos
What happened
Abiomed, Inc., of Danvers, Massachusetts, recalled the Impella Optical Controller, Automated Impella Controller, and Impella Connect Package due to the potential for purge cassette recognition issues because of the failure of the purge flag component of the purge pressure sensor assembly.
The FDA added the recall to its Enforcement Report on September 16, 2026, after Abiomed began the recall on August 12, 2026. The products were distributed nationwide in the United States and internationally in many listed locations.
Summary by Recall Canary from the FDA notice.
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 your package affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU;
Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA;
Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU;
Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP;
Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK;
Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US;
Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR;
Product Code: 0042-0040-KR;- UDI-DI
- 00813502012972
- 00813502012958
- 00813502012217
- 00813502013160
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, IN;
Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP;
Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK;
Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US;
Product Code: 0042-0000-US.- UDI-DI
- 00813502010022
- 00813502011289
Product details
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU;
Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU;
Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN;
Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK;
Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US;
Product Code: 0042-0010-US.- UDI-DI
- 00813502010930
- 00813502010961
Details
- Company began the recall
- Sold in
Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;
- Event ID
- 99671
- Recall numbers
- Z-3148-2026 to Z-3150-2026
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
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
