Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (aic)

Recalling firm
Heart Pump Controller
Reason
Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.
Category
medical device recall
Country
United States
Agency
FDA-MEDWATCH-RSS
Recall date
2026-11-09
Status
Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/f92a47f5-e140-493e-98c2-a0c71b7b0783