Abiomed, Inc.: Temporary Non-roller Type Left Heart Support Blood Pump
Recall Summary Abiomed is recalling certain Impella Controller devices used to operate heart support pumps because a safety alarm that indicates a blocked purge system may display late or be delayed. The affected controllers were distributed in Australia, Canada, France, Germany, and Kuwait, particularly when used with first-generation Impella 5.5 pumps.
- Recalling firm
- Abiomed, Inc.
- Product
- Automated Impella Controller (AIC), labeled as the following with 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. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC...
- Reason
- Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-16
- Status
- Open, Classified
- Distribution
- International distribution in the country of Australia, Canada, France, Germany, Kuwait.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f3c9b4a4-532a-480f-9365-6dc9b88516e3