Device recall
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Recall number
- Z-0117-2027
- Event id
- 99836
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- LeMaitre Vascular, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 28, 2026
- Center classification date
- Oct 7, 2026
- Product code
- DXE
- Device type
- Catheter, Embolectomy
- Reason
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Root cause
- Under Investigation by firm
- Quantity
- 54
- Code info
- Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K022145
- Location
- Burlington, MA, United States