BEUDAMED
    FDA Recall Terminated

    Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.

    Recall: Z-1692-2009 · Initiated July 20, 2009

    Recall

    Recall Number
    Z-1692-2009
    Event Number
    52715
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 20, 2009
    Posted
    July 28, 2009
    Terminated
    March 4, 2010
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.

    Reason

    Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.

    Action

    Boston Scientific sent Customer notification letters via Federal Express Priority mail on July 20, 2009. A total of 812 US consignees were notified and a total of 26 consignees in Puerto Rico. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.

    Distribution

    Nationwide distribution, including Puerto Rico.

    Quantity

    26,935 kits