OVERLOOKED

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Class IIOngoing

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

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
LeMaitre Vascular, Inc.
Reason
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99836…

Products

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

    Codes/lots: Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;Quantity: 54Recall no. Z-0117-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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