Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 32 3rd Ave · Burlington, MA · 01803-4414
Is this the product you have?
- TufTex¿ Over-the-Wire Embolectomy Catheter
- Catalog NumberE1651-88
- Lot codes and dates
- Catalog NumberE1651-88
- UDI-DI00840663100866
- Lot NumberXOT00002181
- Amount recalled
- 54
Where it was sold
Why it was recalled
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
This product could cause temporary or reversible health problems — stop using it.
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