The FDA has classified a recall of Abiomed Impella RP Flex devices as Class I, indicating a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The specific issue identified is a malfunction of the differential pressure (dP) sensor, which may lead to sensor value drift. This recall impacts devices distributed globally, including nationwide in the US, and in several European and Asian countries.

Medical device manufacturers and healthcare providers involved with the Impella RP Flex device must immediately cease use of affected units and follow the manufacturer's instructions for return or remediation. Given the Class I designation, the potential for serious adverse health events necessitates prompt action to mitigate risks to patients. Compliance officers should ensure their organizations have procedures in place to identify and manage recalled medical devices.