BEUDAMED
    FDA Recall Terminated

    St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.

    Recall: Z-0763-2013 · Initiated January 18, 2013

    Recall

    Recall Number
    Z-0763-2013
    Event Number
    64155
    Firm
    St Jude Medical Inc
    FEI Number
    2126673
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 18, 2013
    Posted
    February 11, 2013
    Terminated
    May 21, 2013
    Address
    177 E County Road B, Saint Paul, MN, 55117-1951

    Description

    St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.

    Reason

    The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.

    Action

    St. Jude Medical sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated January 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were advised to discontinue use of the device and remove it from inventory. Customers should contact their SJM sales representative for questions relating to this recall.

    Distribution

    Nationwide Distribution-including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, and WI.

    Quantity

    635