FDAFDA recall Z-0117-2027 · Oct 14, 2026
LeMaitre Vascular, Inc.: TufTex¿ Over-the-Wire Embolectomy Catheter recall
Recall found
Product
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Reason for recall
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Quantity
- 54
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Recalling firm
- LeMaitre Vascular, Inc., Burlington, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-28
Source: openFDA enforcement record Z-0117-2027 · search recall number Z-0117-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.