Events

Rappel de Sinus-SuperFlex-635 Self-expanding Nitinol Stent System

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

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-2015-RN-00701-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-08-12
  • 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-2015-RN-00701-1
  • 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
    An investigation of field complaints indicates an increased number of deployment issues. non-deployments were reported as well partial deployments of the stent. partially deployed stents may require additional intervention by a doctor due to stent elongation or fracture.This does not affect any patients with an implanted stent of this length since the problem may only occur during the implantation of the stent.
  • Action
    Customers are advised to remove all affected products from their inventory and quarantine them in a separate area for collection by Pyramed Pty Ltd. This action has been closed-out on 18/02/2016.

Device

Sinus-SuperFlex-635 Self-expanding Nitinol Stent System
  • Modèle / numéro de série
    Sinus-SuperFlex-635 Self-expanding Nitinol Stent SystemModel numbers: 8606-6200 and 8607-6200Lot Numbers: Q009591, Q009592, Q008259, Q010150 and Q015955ARTG Number: 178915
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd