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Medical Device

Impella RP Flex with SmartAssist. Product Code: 1000323.

Recall date: 2026-03-11 · Source: FDA_DEVICE
Brand / Firm
Abiomed, Inc.
Product
Impella RP Flex with SmartAssist. Product Code: 1000323.
Reason for recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Units affected
4,496 units
Description
Impella RP Flex with SmartAssist. Product Code: 1000323.
View official recall notice →