BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

    Recall: Z-2206-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2206-2020
    Event ID
    85582
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 10, 2020
    Initiation Date
    April 10, 2020
    Classification Date
    June 2, 2020
    Termination Date
    April 27, 2021
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

    Reason

    Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.

    Code Info

    Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332

    Distribution

    No US Distribution. OUS: Netherlands, France, and Sweden

    Quantity

    24 Pumps