United StatesWhat's being recalled
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Recalling firm: LeMaitre Vascular, Inc., Burlington, MA, United States.
How to identify it
Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
The hazard
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
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 Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
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)