Events

Recall of MIO INFUSION SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSULINPUMPS.CA 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
    86242
  • Event Risk Class
    I
  • Event Initiated Date
    2017-09-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. the reported incidence rate requiring medical assistance related to thisissue is less than 1 in every 2 million infusion sets. over-delivery of insulin can cause hypoglycemia and in extreme cases death. medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid may occur if insulin alcohol or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. infusion sets currently being shipped by medtronic contain a new and enhanced membrane material that significantly reduces this risk.

Device

MIO INFUSION SETS
  • Model / Serial
    Model Catalog: MMT-975600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-965600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-943600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-941600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-921600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-923600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-862 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-866 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-874 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-864 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-398600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-397600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-387600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-386600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-396600 (Lot serial: >10 lot numbers cont
  • Product Description
    MIO INFUSION SETS
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

INSULINPUMPS.CA INC.
  • Manufacturer Address
    OAKVILLE
  • Source
    HC