BEUDAMED
    FDA Recall Terminated

    The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.

    Recall: Z-1032-2012 · Initiated January 5, 2012

    Recall

    Recall Number
    Z-1032-2012
    Event Number
    60996
    Firm
    St Jude Medical Inc
    FEI Number
    2126673
    Product Code
    OAD
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    January 5, 2012
    Posted
    February 14, 2012
    Terminated
    September 4, 2014
    Address
    177 E County Road B, Saint Paul, MN, 55117-1951

    Description

    The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.

    Reason

    Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.

    Action

    The notification letter was dated January 5th, 2012 and titled "Product Recall RF Generator 1500T9-CP". The letter informed customers that a St Jude Medical 1500T9-CP RF Generator unit had been distributed to them while currently under FDA review as part of a PMA supplement application. The letter requested that the use of the impacted generator be discontinued. Customers were requested to return the field action form and return the unit identified in the letter. The contact number provided in the letter is: 651-756-2000.

    Distribution

    Nationwide Distribution, including the states of Kansas and Maryland.

    Quantity

    2 units