Impella RP Flex with SmartAssist. Product Code: 1000323.
Class I- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- State
- MA
- Status
- Ongoing
- Recall number
- Z-1470-2026
- Recall initiated
- January 27, 2026