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Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Recalled March 11, 2026 · FDA recall Z-1470-2026 · Abiomed
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. · FDA Class I
Units
4,496 units
Sold at
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Description
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Product
Impella RP Flex with SmartAssist. Product Code: 1000323.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →