FDA-Device2026-03-11Class I
Impella RP. Product Code: 0046-0011.
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
179 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella RP. Product Code: 0046-0011.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1471-2026Original summary
Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Affected quantity: 179 units
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