United StatesImpella CP Set with SmartAssist (GTIN 00813502012279) identified by product codes 1000080, 1000851, 0048-0014, and 0048-0024-JP and serial numbers 677223, 672986, 673252, 644591, 645428, 644314, 613525, 636173, 499250, and 661216 is affected. The devices were recalled because exposure to a low purge pressure occurrence may cause persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
What's being recalled
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
The hazard
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
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
US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
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)