BEUDAMED
    FDA Recall Terminated

    Paradigm Model 511 and 512 Insulin Infusion Pumps

    Recall: Z-0168-04 · Initiated August 29, 2003

    Recall

    Recall Number
    Z-0168-04
    Event Number
    27474
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2003
    Posted
    November 27, 2003
    Terminated
    September 2, 2005
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Paradigm Model 511 and 512 Insulin Infusion Pumps

    Reason

    Water ingresses into the device when in prolonged contact with water causing device to malfunction.

    Action

    The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.

    Distribution

    Nationwide and Canada

    Quantity

    Approximately 61,000 patients