TemporaryFDAOngoing
Can cause harm that is usually temporary.
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Check the device or its packaging for
Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Why
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Distributed
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Company
- LeMaitre Vascular, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0117-2027 · retrieved 7 October 2026
Read the official notice