LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter
- Recalling company
- LeMaitre Vascular, Inc.
- Product
- TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Reason
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 28, 2026
- Reported
- Oct 14, 2026
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Status
- Ongoing
- Quantity
- 54
- Lot / codes
- Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Company location
- Burlington, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0117-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0117-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.