FDA Issues Early Alert on Abiomed Impella RP Flex Heart Pumps

The US Food and Drug Administration (FDA) has issued an early alert regarding a correction to Abiomed’s Impella RP Flex heart pumps, following reports of a malfunction risk linked to 22 serious injuries. Abiomed, part of Johnson & Johnson, notified customers last week that a differential pressure sensor in certain Impella RP devices may drift over time, leading to inaccurate readings.

According to the FDA, sensor drift can cause erroneous flow and performance data to appear on automated Impella controllers, prompting clinicians to make incorrect device adjustments or perform unnecessary pump exchanges. While the issue does not affect the pump’s ability to provide hemodynamic support, the FDA said it is not possible to directly verify flow calculation errors from pump signals alone when drift occurs.

J&J is updating the devices’ instructions for use and advised clinicians to rely on standard hemodynamic monitoring and imaging rather than displayed values. The FDA is continuing to review the issue, noting that early alerts can precede formal recall actions.

06-02-2026