BEUDAMED
    FDA Recall Terminated

    Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.

    Recall: Z-0936-2007 · Initiated April 27, 2007

    Recall

    Recall Number
    Z-0936-2007
    Event Number
    37869
    Firm
    Zoll Lifecor Corporation
    FEI Number
    3008642652
    Product Code
    MVK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 27, 2007
    Posted
    June 15, 2007
    Terminated
    March 6, 2008
    Address
    121 Freeport Rd, Pittsburgh, PA, 15238-3411

    Description

    Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.

    Reason

    The electrodes do not properly release conductive gel

    Action

    Patients currently using the product should continue to do so while the product removal is underway. Product replacements will begin with the belts currently in the possession of the sales reps. By replacing these first any new patients will be receiving new or refurbished belts with new Therapy Electrodes that have not been exposed to methanol. As patients complete their use of the LifeVest and return their device to the firm the belt's refurbishment process will include replacement of all 3 Therapy Electrodes. The firm expects this process to be completed in approximately 3 months based on the average use of time and current production capabilities. The process may take an additional month for devices distributed overseas. Physicians with active patients were notified via letter sent certified mail on 5/3/07. Long term use patients (patients using the device longer than 3 months) will be notified of the product removal via telephone and follow up letter. Each long term patient will be provided with a replacement belt. They will be instructed to return their existing belt in the same shipping box. Due to the low residual risk no notification is planned for short term use patients. Prescribing physicians have the option to notify their patients if they choose to do so.

    Distribution

    Worldwide: The product was shipped to patients in AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV. The product was also shipped to Germany, United Kingdom, Italy, Spain, France, and Denmark.

    Quantity

    944 belts