medical MODERATE Updated 2026-10-14

LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number:

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Recalled Product

TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;

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Hazard / Issue

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall