Events

Recall of Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.

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

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
    28214
  • Event Risk Class
    Class 3
  • Event Number
    Z-0531-04
  • Event Initiated Date
    2004-01-28
  • Event Date Posted
    2004-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31389
  • 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
    Pump, Infusion, Insulin - Product Code LZG
  • Reason
    A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.
  • Action
    Firm will send a Product Performance Update in all new shipments of the model 7311 version 5.0B software and it will be provided to all customers already receiving the version B software. When available, version 5.0c will be provided to customers with A or B software.

Device

Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
  • Model / Serial
    All software versions 5.0A and 5.0B
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    undisclosed, assumed to be nationwide.
  • Product Description
    Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
  • Manufacturer
    Medtronic MiniMed

Manufacturer

Medtronic MiniMed
  • Manufacturer Address
    Medtronic MiniMed, 18000 Devonshire St, Northridge CA 91325-1219
  • Source
    USFDA