BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

    Recall: Z-1271-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1271-2016
    Event ID
    73426
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2016
    Initiation Date
    February 9, 2016
    Classification Date
    March 29, 2016
    Termination Date
    August 11, 2016
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

    Reason

    Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure.

    Code Info

    N558983006

    Distribution

    Internationally to Japan.

    Quantity

    9 (1 still unused)