FDAFDA · Food and drugs·Recall number Z-1470-2026
Impella RP Flex with SmartAssist. Product Code: 1000323.
Published March 11, 2026 · Recall initiated: January 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abiomed, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- Lot
- Product Code: 1000323. UDI-DI: 00813502012811.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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