Abiomed Recalls Impella Heart Pump Controllers After 3 Deaths

Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pumps after three deaths were linked to a detection fault. The issue prevents the controller from recognizing the connected pump and fails to trigger an alarm, risking insufficient cardiac support.

The FDA issued an early alert, flagging it as a potentially high-risk concern. While the devices remain on the market, Abiomed has provided instructions to reduce risks, including using backup controllers and switching consoles if screens freeze for over 20 seconds.

The fault can occur during console transfers or at case start, both causing screen freezes that delay pump detection. Since J&J acquired Abiomed in December 2022, 46 products have been recalled. The company also received a warning from the FDA in 2023 for not reporting quality issues and using unapproved software.

09-07-2025