BEUDAMED
    FDA Recall Terminated

    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).

    Recall: Z-0061-2008 · Initiated September 14, 2007

    Recall

    Recall Number
    Z-0061-2008
    Event Number
    44942
    Firm
    Zoll Lifecor Corporation
    FEI Number
    3008642652
    Product Code
    MVK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 14, 2007
    Posted
    October 18, 2007
    Terminated
    June 13, 2008
    Address
    121 Freeport Rd, Pittsburgh, PA, 15238-3411

    Description

    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).

    Reason

    Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.

    Action

    Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.

    Distribution

    The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.

    Quantity

    2006 packs