Recall Z-1470-2026— Abiomed, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abiomed, Inc., initiated 2026-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella RP Flex with SmartAssist. Product Code: 1000323.. Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-01-27
- Firm location
- Danvers, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.