BEUDAMED
    FDA Recall Terminated

    Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47

    Recall: Z-0351-03 · Initiated November 11, 2002

    Recall

    Recall Number
    Z-0351-03
    Event Number
    25150
    Firm
    Medtronic Cardiac Surgery Technologies
    FEI Number
    3003368396
    Product Code
    74
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2002
    Terminated
    July 2, 2004
    Address
    7601 Northland Drive, Minneapolis, MN, 55428

    Description

    Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47

    Reason

    The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.

    Action

    A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives.

    Distribution

    All of the consignees were in foreign countries in Europe, Asia and Latin America.

    Quantity

    148 pens