BEUDAMED
    FDA Recall Terminated

    Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.

    Recall: Z-0895-2015 · Initiated November 21, 2014

    Recall

    Recall Number
    Z-0895-2015
    Event Number
    69713
    Firm
    Atricure Inc
    FEI Number
    3011706110
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 21, 2014
    Posted
    December 30, 2014
    Terminated
    July 20, 2015
    Address
    6217 Centre Park Drive West, Chester, OH, 45069

    Description

    Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.

    Reason

    Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.

    Action

    AtriCure sent an Urgent Recall Notification letter dated November 21, 2014 with Acknowledgement Form to all affected customers. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to notify their customers at once of this product recall. Customers were instructed to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. For any questions, call the toll-free Recall Hotline (844-783-5302), M-F, 8:00 AM-8:00 PM EST.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, Hong Kong, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JAPAN, FRANCE, FINLAND, LUXEMBOURG, Korea, SWITZERLAND, SWEDEN, Malaysia, ISRAEL, NORWAY, AUSAtralia, COLOMBIA, TURKEY, Thailand, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK. The affected product was also distributed to 17 government consignees.

    Quantity

    19,190 units