The FDA has classified a recall for Abiomed Impella RP devices (Product Code: 0046-0035) 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 issue stems from a differential pressure (dP) sensor malfunction, leading to sensor value drift.

Healthcare providers using these devices should be aware of the potential for inaccurate sensor readings. While the document does not specify immediate actions for providers, the classification as Class I implies a significant risk. Abiomed is distributing these devices worldwide, including across the US. The recall is marked as ongoing, suggesting continued monitoring and potential further action by the FDA and the manufacturer.