BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.

    Recall: Z-1031-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1031-2013
    Event ID
    64497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    February 27, 2013
    Classification Date
    April 2, 2013
    Termination Date
    November 21, 2013
    Address
    7000 Central Ave NE, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.

    Reason

    Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equi

    Code Info

    all Model 8930 radio frequency (RF) generators are affected

    Distribution

    Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.

    Quantity

    848 (696 US, 152 OUS)