BEUDAMED
    FDA Recall Terminated

    Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units

    Recall: Z-1986-2013 · Initiated July 3, 2013

    Recall

    Recall Number
    Z-1986-2013
    Event Number
    65644
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 3, 2013
    Posted
    August 20, 2013
    Terminated
    January 16, 2014
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units

    Reason

    Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not

    Action

    An Urgent Medical Device Recall notice was sent to customers on July 3, 2013, who purchased the Medtronic Paradigm Reservoirs MMT-326A and MMT-332A. The recall letter informed the customers of the problems and the actions to be taken. Medtronic instructed customers that they will replace all reservoirs from the affected lots at no cost. Customers are instructed to refer to www.medtronicdiabetes.com/support/product-updates for a list of frequently asked questions. Customers are instructed to report adverse reactions or quality problems experienced with the use of Medtronic Diabetes insulin pumps, infusion sets or reservoirs to FDA's MedWatch Adverse Event Reporting Program. Customers are instructed to call for replacements at (866) 222-2584 Monday through Friday (8am-6pm) central time. Customers with an urgent issue may use the 24 hour helpline.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela.

    Quantity

    669,672 units