LeMaitre Vascular recalls

Recall found. LeMaitre Vascular is named in FDA Class II recall Z-0117-2027 covering TufTex¿ Over-the-Wire Embolectomy Catheter. Hazard: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. Identifying details: Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;. Status: Ongoing.

Models with recalls

TufTex¿ Over-the-Wire Embolectomy Catheter (1)

All LeMaitre Vascular recalls

FDA Class II · Medical device · October 14, 2026

TufTex¿ Over-the-Wire Embolectomy Catheter recall — LeMaitre Vascular, Inc.

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

Official ID Z-0117-2027 · Official record ↗

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CPSC — consumer products ↗ (aggregated here)
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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.