medical Class I Updated 2026-03-11

Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.

Recalled Product

Impella RP with SmartAssist. Product Code: 0046-0035.


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: 0046-0035. UDI-DI: 00813502011869.
View official government recall

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