The FDA has issued a Class I recall for Abiomed Impella RP devices (Product Code: 0046-0011) due to a malfunction in the differential pressure (dP) sensor. This malfunction can cause sensor values to drift, posing a risk to patient safety. The recall is ongoing and affects devices distributed worldwide, including in the US and several European countries.

Healthcare providers and medical device manufacturers using or distributing the Impella RP device must be aware of this recall. While the document does not specify immediate actions for compliance officers, it highlights a critical product safety issue. Entities should review their inventory and patient usage of this device and follow manufacturer guidance for any necessary actions or reporting related to this ongoing recall.