BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0228-2023
    Event ID
    91006
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    September 30, 2022
    Classification Date
    November 11, 2022
    Address
    32 3rd Ave, N/A, Burlington, MA, 01803-4414, United States

    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.

    Code Info

    Lots XSL0097, XSL0098, and XSL0099

    Distribution

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

    Quantity

    72 (OUS only)