Tag: heart_pump

FDA Issues Early Alert on Abiomed Heart Pump Controller Quality Issues

23 Sep 2026 3:22 p.m. · Source: US Food and Drug Administration

Abiomed has told customers to remove certain Automated Impella Controllers from use or sale over hardware, firmware and software quality issues, though hospital inventory can still be used.

Health Business Science & Technology USA Medical Science Law Enforcement Social Issues FDA Abiomed Automated Impella Controller Medical Device Recall Heart Pump Product Recall Patient Safety Food Recalls Drugs
Abiomed Recalls Heart Pump Controllers Following Deaths and Injuries

26 Aug 2026 3:21 p.m. · Source: US Food and Drug Administration

Abiomed is recalling Automated Impella Controllers due to purge cassette recognition issues, linked to 37 serious injuries and three deaths. The FDA has issued an Early Alert, advising removal of affected devices.

Health Business Science & Technology Medical Science Abiomed Impella Controller FDA Medical Device Recall Heart Pump Patient Safety Product Recall Food Recalls Drugs
FDA Issues Class I Recall for Abiomed Impella Heart Pump Controllers

22 Jun 2026 11:24 a.m. · Source: US Food and Drug Administration

The FDA has upgraded an alert for Abiomed's Automated Impella Controllers to a Class I recall, the most serious type, following two injuries and one death. The recall focuses on updated usage instructions to prevent serious harm, not device removal.

Health Business Law Enforcement Medical Science Legal Social Issues FDA Abiomed Automated Impella Controllers Class I recall Heart pump Medical device Product Recall Food Recalls Drugs

Tag: heart_pump

FDA Issues Early Alert on Abiomed Heart Pump Controller Quality Issues

Abiomed Recalls Heart Pump Controllers Following Deaths and Injuries

FDA Issues Class I Recall for Abiomed Impella Heart Pump Controllers