LeMaitre Vascular, Inc.: TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Read the official notice at FDA (device) →
Get alerts for LeMaitre Vascular
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- LeMaitre Vascular, Inc.
- Product
- TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Reason / hazard
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Recall initiated
- 2026-08-28
- Code info
- Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Product quantity
- 54
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Burlington
- State
- MA
- Country
- United States
- Event id
- 99836
Free daily digest + "My products" watchlist