Abiomed, Inc.: Impella RP. Product Code: 0046-0011.

Hazard

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Details from the source

Reason for recall: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Quantity: 179 units Lot/code info: Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.

UPC codes

04260113630273

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.