Impella RP Flex with SmartAssist
Abiomed is recalling the Impella RP Flex with SmartAssist due to a potential malfunction of the differential pressure sensor.
Contact your healthcare provider or facility if you have concerns regarding the use of this device. Healthcare professionals should review the manufacturer's urgent medical device correction notice and follow the provided instructions for monitoring and managing sensor drift.
Why it was recalled
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
How to identify it
UPC 00813502012811
Impella RP Flex with SmartAssist. Product Code: 1000323.
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification