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FDA DeviceClass INotable

FDA Recall: Impella RP Flex with SmartAssist. Product Code: 1000323.

Date: 2026-03-11
Brand: Abiomed, Inc.
Category: Medical Device
FDA Class: Class I

Description

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

Hazard

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

Remedy

4,496 units

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