The U.S. Food and Drug Administration (FDA) has issued an Early Alert, sharing that Abiomed has updated use instructions for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices.

The alert warns that the differential pressure sensor in Impella RP devices may malfunction, resulting in sensor values drifting over time. "If sensor drift occurs, the Automated Impella Controller may display inaccurate information, including pump flow readings, Pulmonary Artery Placement Signal, Pulmonary Artery Pulsatility Index, and Central Venous Placement Signal," the agency states.

Access the FDA website for more information.

Keywords: United States Food and Drug Administration, Pulmonary Artery, ACC Advocacy