BEUDAMED
    FDA Enforcement Class II Terminated

    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

    Recall: Z-0689-2016 · Reported February 3, 2016

    Enforcement

    Recall Number
    Z-0689-2016
    Event ID
    72965
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 3, 2016
    Initiation Date
    December 22, 2015
    Classification Date
    January 22, 2016
    Termination Date
    July 25, 2017
    Address
    400 N Daniels Way, N/A, Bloomington, IN, 47404-9155, United States

    Description

    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

    Reason

    Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event

    Code Info

    Catalog Prefix ZIVX5. All Lots

    Distribution

    Nationwide Worldwide

    Quantity

    753