BEUDAMED
    FDA Recall Terminated

    V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.

    Recall: Z-1401-2010 · Initiated December 5, 2008

    Recall

    Recall Number
    Z-1401-2010
    Event Number
    54004
    Firm
    Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
    FEI Number
    3008262715
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2008
    Posted
    April 16, 2010
    Terminated
    October 21, 2010
    Address
    201 Technology Dr, Irvine, CA, 92618-2400

    Description

    V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.

    Reason

    Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety information.

    Action

    The recall was initiated with Endocare sending a notification letter to identified customers on December 5, 2008 and offering an optional replacement unit. The initial correspondence was sent out via an e-mail if the correspondence was returned undeliverable or an e-mail address was not available it was then sent Federal Express to those recipients. The notification letter explained the reason for recall and requested providers refocus their attention on the Indications & Safety Review information contained in the Endocare's Physician Training Materials. Physicians were instructed to contact the firm at 1-949-450-5412 to discuss any questions they may have about the information in the notification letter.

    Distribution

    Nationwide.

    Quantity

    22,741 units total for all products