Official recall notice
FDA Recall: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod
- Recall date
- 2026-06-03
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This 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.
Recommended action
What to do
625 units
Product description
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This 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.