BEUDAMED
    FDA Enforcement Class II Terminated

    1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J 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-2544-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2544-2016
    Event ID
    74880
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    August 3, 2016
    Classification Date
    August 16, 2016
    Termination Date
    April 8, 2021
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    Description

    1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J 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

    Code Info

    Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10

    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

    380 units