Device product
Impella RP with SmartAssist. Product Code: 0046-0035.
Z-1469-2026
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 98276
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 291 units
- Official record key
device-enforcement:Z-1469-2026
Official wording
Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Code information: Product Code: 0046-0035. UDI-DI: 00813502011869.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Derived failure modes
-
Unknown
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.