medical Class I Updated 2026-03-11

Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.

Recalled Product

Impella RP Flex with SmartAssist. Product Code: 1000323.


Hazard / Issue

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 1000323. UDI-DI: 00813502012811.
View official government recall

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