Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers

Recalling firm
Heart Pump Controller
Reason
Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
Category
medical device recall
Country
United States
Agency
FDA-MEDWATCH-RSS
Recall date
2026-09-24
Status
Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/e8572d26-212e-48ad-871e-1619c59661c7