TufTex¿ Over-the-Wire Embolectomy Catheter recall (LeMaitre Vascular, Inc.)
Medical deviceClass IIOngoing
Summary: LeMaitre Vascular, Inc. is recalling 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.
What is being recalled
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Why
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC. (states named: California, Florida, Georgia, Kentucky, Louisiana, New Jersey, Ohio, Pennsylvania, South Carolina)
How to tell if yours is affected
Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0117-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 28, 2026 |
| Reported | October 14, 2026 |
| Company | LeMaitre Vascular, Inc. |
| Company location | Burlington, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 54 |
More recalls from LeMaitre Vascular, Inc. · all medical device recalls · recalls from August 2026