BEUDAMED
    FDA Recall Open, Classified

    The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)

    Recall: Z-2468-2023 · Initiated July 13, 2023

    Recall

    Recall Number
    Z-2468-2023
    Event Number
    92825
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    MGZ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 13, 2023
    Posted
    August 28, 2023
    Address
    32 3rd Ave, Burlington, MA, 01803-4414

    Description

    The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)

    Reason

    Burrs (molding flash) on the cutter may tear the harvested vien

    Action

    LeMaitre issued Field Safety Notice (FSN) Chevalier Valvulotome (FSCA Ref: CAPA 2023-022) on July 13, 2023 to OUS Customers. Letter states reason for recall, health risk and action to take: Please quarantine the affected devices. Then, return the faxback/reply form (at the end of this FSN) to LeMaitre Vascular as soon as possible. Then, LeMaitre will give you instructions on how to return the devices.

    Distribution

    International distribution to the countries of Belgium, France, Germany, and United Kingdom.

    Quantity

    225 units