Events

Recall of MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2014-RN-00545-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00545-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, inspiremd, has initiated this recall action due to recent complaints of mguard prime eps dislodgements. these complaints have primarily occurred during the preparation of the mguard prime eps, upon removal of the protective sleeve, or during withdrawal of the mguard prime eps into the guide catheter during the procedure. these complaints have not resulted in any patient injury.
  • Action
    Upon getting appropriate regulatory approval, InspireMD intends to perform a manufacturing enhancement to all unexpired units of the MGuard Prime EPS systems to improve stent retention and product performance.

Device

MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia