United StatesImpella 5.5 with SmartAssist S2 (including Impella 5.5 with SmartAssist S2 Set, AU) bearing Catalog Number 1000482, Australian Configuration Code 1000770, GTIN 00813502012828, serial numbers 621454, 621455, 621448, 621449, 621450, and 621451, and expiration date 6/30/27 is affected. The devices were recalled because they were packaged in an incorrect outer box carton.
What's being recalled
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
The hazard
Device packaged in incorrect outer box carton.
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
International distribution to the country of Australia and Taiwan.
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)