BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2173-2014 · Initiated June 16, 2014

    Recall

    Recall Number
    Z-2173-2014
    Event Number
    68633
    Firm
    Medtronic MiniMed Inc.
    FEI Number
    3003166194
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 16, 2014
    Posted
    August 8, 2014
    Terminated
    September 25, 2014
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    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.

    Action

    An Urgent Field Safety Notice Letter dated 6/16/14 was sent to all customers who purchased the Medtronic Implantable Insulin Pump. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that Medtronic MiniMed is working to make new unaffected pumps available as soon as possible. Customers are instructed to contact Elisabeth Andrieu at + 33 6 89 71 9056 or Dr. Francine Kaufman at +1 818.576.5331.

    Distribution

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

    Quantity

    764 units