Events

Recall of MiniMed Model 512 Insulin Infusion Pumps

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
    30059
  • Event Risk Class
    Class 3
  • Event Number
    Z-0011-05
  • Event Initiated Date
    2004-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35098
  • 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
    Several complaints of pumps exhibiting a47 alarms were received. investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. the investigation revealed this only occurs when the pump is programmed to display information in spanish.

Device

MiniMed Model 512 Insulin Infusion Pumps
  • Model / Serial
    Paradigm model 512pumps with serial numbers that end in '-Axx4' . Where 'x' can be any number or letter.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide & Spain
  • Product Description
    Medtronic MiniMed Paradigm Model 512
  • Manufacturer
    Medtronic MiniMed

Manufacturer

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