Abiomed Automated Impella Controller
Abiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
Healthcare providers should review the updated instructions for use and ensure that the purge system is monitored closely for signs of blockage. Contact Abiomed for further guidance on software updates or operational changes.
Recall at a glance
- Quantity recalled
- 62 units
Why it was recalled
Abiomed is recalling various Automated Impella Controller models due to a potential delay in the "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This issue could lead to a failure to detect purge system blockages, potentially resulting in serious injury or death.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UDI-DI |
|---|---|
| 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; Prod | 00813502011272, 00813502011289, 00813502011296, 00813502010022, 00813502010961, 00813502010978, 00813502012958, 00813502012217, 00813502012972 |
| Automated Impella Controller (AIC), labeled as | – |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification