Events

Recall of Device Recall MiniMed 620G, MiniMed 640G

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76436
  • Event Risk Class
    Class 2
  • Event Number
    Z-1890-2017
  • Event Initiated Date
    2017-01-31
  • Event Date Posted
    2017-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153210
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • Reason
    Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. when the software anomaly occurs it leads to battery depletion and pump shutdown.
  • Action
    A urgent medical device recall letter was sent to customers on 1/31/17 to inform them that Medtronic has identified a software issue that could prevent the internal battery of the pump from charging. Customers are informed that should the software issue occur, an alarm is triggered and they will see the following message displayed on the pump screen: "Power error detected 00:00 25 Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See user guide. OK." Customers are informed that If they experience the alarm and see the Power error detected message on their pump accompanied by the number 25, then they are instructed to contact the Medtronic HelpLine team at XXXXX for assistance with troubleshooting the error.

Device

Device Recall MiniMed 620G, MiniMed 640G
  • Model / Serial
  • Distribution
    Europe, Australia, Japan, Singapore
  • Product Description
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Manufacturer Address
    Medtronic Inc., 18000 Devonshire Street, Northridge CA 91325-1219
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA