BEUDAMED
    FDA Enforcement Class II Terminated

    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

    Recall: Z-1814-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1814-2017
    Event ID
    76769
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    March 7, 2017
    Classification Date
    April 12, 2017
    Termination Date
    February 16, 2018
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

    Reason

    Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.

    Code Info

    Item # FH620R

    Distribution

    Product was distributed throughout the United States and Canada.

    Quantity

    21 units distributed in U.S.