BEUDAMED
    FDA Recall Open, Classified

    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

    Recall: Z-0228-2023 · Initiated September 30, 2022

    Recall

    Recall Number
    Z-0228-2023
    Event Number
    91006
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DXE
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    September 30, 2022
    Posted
    November 11, 2022
    Address
    32 3rd Ave, Burlington, MA, 01803-4414

    Description

    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

    Reason

    Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

    Action

    On September 30, 2022, the recalling firm notified affected customers via Urgent Field Safety Notice letters. Users were instructed to immediately identify, quarantine, and return the affected devices.

    Distribution

    No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.

    Quantity

    72 (OUS only)