BEUDAMED
    FDA Recall Terminated

    1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

    Recall: Z-2543-2016 · Initiated August 3, 2016

    Recall

    Recall Number
    Z-2543-2016
    Event Number
    74880
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    MGZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 3, 2016
    Terminated
    April 8, 2021
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

    Reason

    Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

    Action

    LeMaitre Vascular, Inc. sent an Urgent Medical Device Recall letter dated June 29, 2016 to customers via priority mail. The letter identified the affected product, problem and actions to be taken. Customers were requested to locate, quarantine and return the devices. Customers were instructed to complete and return the response form to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product will be requested to be returned and replaced. For questions call 781-221-2266 ext. 183.

    Distribution

    Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.

    Quantity

    1992 units