BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

    Recall: Z-2325-2015 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-2325-2015
    Event ID
    71756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2015
    Initiation Date
    July 17, 2015
    Classification Date
    August 3, 2015
    Termination Date
    April 7, 2016
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

    Reason

    The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain.

    Code Info

    LOT No: 0007525461. 0007599312

    Distribution

    Worldwide Distribution - US (nationwide) and Canada.

    Quantity

    1415 total