Abiomed has issued two recalls affecting Impella heart pump systems and related components due to device performance issues and patient safety risks.
The first action involves a correction to Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices after the company identified a potential malfunction in the differential pressure sensor, according to an April 3 FDA news release. The issue may cause inaccurate pump flow and pressure readings, leading to inappropriate clinical interventions. As of Jan. 15, Abiomed reported 22 serious injuries and zero deaths.
The second recall affects certain Generation 1 Impella purge cassettes and Impella RP pump sets due to an increased risk of purge leaks, according to a separate April 3 FDA news release. If unaddressed, leaks may lead to low purge pressure, pump failure and loss of hemodynamic support. As of Feb. 3, Abiomed reported four serious injuries and zero deaths tied to this issue.
The FDA classified both actions as its most serious recall category. Abiomed directed providers to remove affected purge cassettes from use and transition to updated components while continuing to use affected heart pumps with updated monitoring and instruction guidance.
