Tag: heart_pump

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.

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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.

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