BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

    Recall: Z-2173-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2173-2014
    Event ID
    68633
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic MiniMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 20, 2014
    Initiation Date
    June 16, 2014
    Classification Date
    August 8, 2014
    Termination Date
    September 25, 2014
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

    Reason

    Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.

    Code Info

    n/a

    Distribution

    New Jersey and Worldwide: Belgium, France, Netherland, and Sweden

    Quantity

    764 units