BEUDAMED
    FDA Recall Terminated

    Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.

    Recall: Z-1248-06 · Initiated May 4, 2006

    Recall

    Recall Number
    Z-1248-06
    Event Number
    35573
    Firm
    Celsion Corporation
    FEI Number
    1122126
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 4, 2006
    Posted
    July 19, 2006
    Terminated
    August 4, 2011
    Address
    10220 Old Columbia Road, Suite L, Columbia, MD, 21046-2364

    Description

    Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.

    Reason

    A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or maintain recommended pressure.

    Action

    Celsion Corporation, the recalling firm, notified consignees by letter 05/04/06 on Boston Scientific Corporation letterhead and advised that the prostatic balloon of the catheter may not achieve and/or maintain the recommended pressure as outlined in the Prolieve User Manual. The notification was sent by courier and included a tracking verification reply form for users to report inventory quantities and to report that all areas of medical facilities holding inventory were checked for recalled product for return via Returned Goods Authorization from contract distributor, Boston Scientific Corporation, Natick, MA.

    Distribution

    Nationwide. The product was distributed to one distributor in MA and 154 end users in medical centers and urology clinics.

    Quantity

    2930 kits