Abiomed Impella Heart Pump Recall is Class 1

FDA says the Abiomed 5/18 recall of certain Impella CP Sets with SmartAssist is Class 1. An agency notice says Abiomed reported that specific distributed units of Impella CP with SmartAssist do not meet design specifications. “This out-of-specification may result in low purge pressure events from the onset of the case,” FDA says.

The notice says exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, and organ hypoperfusion, and risk of death if not promptly corrected,” FDA says. As of 5/7, Abiomed had reported three pump exchanges, which have the potential to result in serious injuries and one death associated with the issue.