United StatesImpella RP devices — Impella RP with SmartAssist (Product Code 0046-0035, UDI‑DI 00813502011869), Impella RP Flex with SmartAssist (Product Code 1000323, UDI‑DI 00813502012811), and Impella RP (Product Code 0046-0011, UDI‑DI 04260113630273) — distributed worldwide are affected. They were recalled because the differential pressure (dP) sensor may malfunction, causing sensor values to drift.
What's being recalled
Impella RP with SmartAssist. Product Code: 0046-0035.
Impella RP Flex with SmartAssist. Product Code: 1000323.
Impella RP. Product Code: 0046-0011.
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
Product Code: 0046-0035. UDI-DI: 00813502011869. Product Code: 1000323. UDI-DI: 00813502012811. Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
The hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)