BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2206-2020 · Initiated April 10, 2020

    Recall

    Recall Number
    Z-2206-2020
    Event Number
    85582
    Firm
    Medtronic Inc.
    FEI Number
    2032227
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 10, 2020
    Posted
    June 3, 2020
    Terminated
    April 27, 2021
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    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.

    Action

    Medtronic initiated verbal communication with affected consignees on April 10, 2020 via phone call and provided affected consignees with an "Urgent Field Safety Notice" via email between the dates of 04/24/20 - 4/30/20. . In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Immediately identify and quarantine all unused affected pumps in your inventory. 2. Return all unused affected pumps in your inventory to Medtronic. Your Medtronic Representative can assist you in the return and replacement of this pump as necessary. 3. Forward this notice to all those who need to be aware within your organization and to any organization where the affected pumps may have been transferred. Please maintain a copy of this notice in your records.

    Distribution

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

    Quantity

    24 Pumps