Abiomed Recalls Impella Heart Pump Controllers Over Detection Fault Linked to 3 Deaths

Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pump system after identifying a critical fault that may prevent detection of the pump during connection—without triggering a visual alarm. The FDA issued an early alert, reserved for potentially high-risk issues, following reports of three patient deaths linked to the problem.

The issue can occur during console-to-console transfer or initial case start, causing the screen to freeze for over 20 seconds, delaying or preventing life-saving hemodynamic support. Abiomed instructed users to switch to another console if this occurs and to keep a backup controller available.

While Abiomed emphasizes this is not a product removal, the recall adds to 46 actions since J&J’s acquisition in late 2022. Regulatory scrutiny has intensified following prior incidents, including a Class I recall and an FDA warning letter for unreported issues and unauthorized software updates.

14-07-2025