BEUDAMED
    FDA Recall Terminated

    Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

    Recall: Z-2777-2015 · Initiated September 1, 2015

    Recall

    Recall Number
    Z-2777-2015
    Event Number
    72136
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 1, 2015
    Posted
    September 17, 2015
    Terminated
    April 8, 2016
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391

    Description

    Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

    Reason

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    Action

    Medtronic began hand delivering an Urgent Medical Device Correction letter on September 1, 2015, to all affected customers. The letter described the issue. Customers were advised to continue using the device, per the operator's manual, and if a system notice appears, they are to carefully read and follow the instructions in the screen of the console. Medtronic personnel will track contact with the customer via Customer Contact Record. Customers with qeustions were instructed to contact their Medtronic AF Solutions representative. For questions regarding this recall call 1-877-464-2796 Technical Services.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    103 units