BEUDAMED
    FDA Recall Terminated

    Medtronic MiniMed Paradigm Model 712

    Recall: Z-0010-05 · Initiated September 14, 2004

    Recall

    Recall Number
    Z-0010-05
    Event Number
    30059
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2004
    Terminated
    March 3, 2005
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic MiniMed Paradigm Model 712

    Reason

    Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.

    Distribution

    Nationwide & Spain

    Quantity

    10,600