BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.

    Recall: Z-1723-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1723-2014
    Event ID
    68295
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    May 2, 2014
    Classification Date
    June 4, 2014
    Termination Date
    October 7, 2014
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.

    Reason

    Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

    Code Info

    N457062003

    Distribution

    Distributed in the state of CT.

    Quantity

    1