← All recalls
Medical Device

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

Recall date: 2026-03-11 · Source: FDA_DEVICE
Brand / Firm
Abiomed, Inc.
Product
Impella RP with SmartAssist. Product Code: 0046-0035.
Reason for recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Units affected
291 units
Description
Impella RP with SmartAssist. Product Code: 0046-0035.
View official recall notice →