Johnson & Johnson's Abiomed unit is removing every Automated Impella Controller worldwide to replace parts linked to failures that have been associated with 37 serious injuries and three deaths, according to the FDA's early alert. Hospitals may keep using their controllers while they wait for service.
The controllers run Impella heart pumps, which temporarily take over part of the heart's pumping work in critically ill patients, including people in cardiogenic shock and those undergoing high-risk heart procedures. The affected U.S. products are the Impella Controller, the Impella Optical Controller, and the Optical Automated Impella Controller packages.
