Abiomed Automated Impella Controller
Abiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
Contact Abiomed or your local representative to schedule the necessary hardware service updates for your controller unit.
Recall at a glance
- Quantity recalled
- 91 units
Why it was recalled
Abiomed is recalling the Automated Impella Controller due to multiple hardware issues that may cause motor control interruption, startup failures, console boot-up failures, or pump and purge stops. These risks stem from potential electrostatic discharge, memory card dislodgement, fan wire damage, and capacitor failures on the power battery manager. The affected units are distributed nationwide.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
- UDI-DI
- 00813502010022
Where it was sold
Distributed nationwide.
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