BEUDAMED
    FDA Recall Terminated

    Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.

    Recall: Z-0172-2008 · Initiated August 2, 2007

    Recall

    Recall Number
    Z-0172-2008
    Event Number
    37912
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 2, 2007
    Posted
    November 28, 2007
    Terminated
    October 5, 2009
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.

    Reason

    Dissolution/Fractures to the leads of the VNS Therapy System

    Action

    Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.

    Distribution

    Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Malta, Mexico, Netherlands, Northern Ireland, Norway, Poland, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.

    Quantity

    34,719 units.