Events

Recall of MICROSTIC PLUS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ARGON MEDICAL DEVICES 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
    28257
  • Event Risk Class
    III
  • Event Initiated Date
    2016-09-09
  • 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
    An issue was identified with the stiffer coaxial micro-introducer 4fr and 5fr after a field complaint reported that the rotating luer detached from the dilator hub during use. the function of the rotating luer is to fasten the dilator to the shield during insertion. affected lots have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath.

Device

MICROSTIC PLUS
  • Model / Serial
    Model Catalog: 497884 (Lot serial: 11149822)
  • Product Description
    MICROSTIC PLUS
  • Manufacturer
    ARGON MEDICAL DEVICES INC.

Manufacturer

ARGON MEDICAL DEVICES INC.