FDA-Device2026-03-11Class I
Impella RP Flex with SmartAssist. Product Code: 1000323.
Abiomed, Inc.
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Affected count
4,496 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella RP Flex with SmartAssist. Product Code: 1000323.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2026Original summary
Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Product Code: 1000323. UDI-DI: 00813502012811. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Affected quantity: 4,496 units
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