LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter
The TufTex Over-the-Wire Embolectomy Catheter can fail under pull force, causing balloon components to fail.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
LeMaitre Vascular, Inc. recalled the TufTex Over-the-Wire Embolectomy Catheter because devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. The recall began on August 28, 2026, and was added to the FDA's Enforcement Report on October 7, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and catalog code listed under your product.
TufTex¿ Over-the-Wire Embolectomy Catheter
- UDI-DI
- 00840663100866
- Catalog code
- E1651-88
- Lot
- XOT00002181
Details
- Company began the recall
- Event ID
- 99836
- Company
- LeMaitre Vascular, Inc.
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
