Johnson & Johnson’s Abiomed division recalled specific Impella CP with SmartAssist heart pumps. An internal review found that certain units failed to meet design specifications. The defect causes persistent low purge pressure alarms that may interrupt circulatory support.
The technical failure is linked to one patient death. The issue is also associated with three serious injuries. The U.S. Food and Drug Administration issued an alert regarding the voluntary recall.
The action affects seven specific product lots within the United States. Abiomed instructed customers to quarantine and return all impacted devices. This is the latest in a series of safety alerts for the Impella platform since Johnson & Johnson acquired Abiomed in 2022.