BEUDAMED
    FDA Recall Terminated

    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.

    Recall: Z-2544-2014 · Initiated March 13, 2014

    Recall

    Recall Number
    Z-2544-2014
    Event Number
    68277
    Firm
    Medtronic MiniMed Inc.
    FEI Number
    3003166194
    Product Code
    OYC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 13, 2014
    Posted
    August 22, 2014
    Terminated
    April 7, 2015
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.

    Reason

    Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.

    Action

    The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement.

    Distribution

    Worldwide Distribution-Nationwide in US

    Quantity

    559,374 units total (444,374 units in US)