Tag: automated_impella_controllers

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