Events

Rappel de MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00545-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00545-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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