Events

Rappel de Zilver PTX Drug-Eluting Peripheral Stent

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia 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-2013-RN-00359-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-26
  • 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-2013-RN-00359-1
  • 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
    Cook medical has received a number of complaint reports relating to the delivery system for the zilver ptx drug eluting stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section. this recall follows from a previous recall for product correction rc-2012-rn-01282-1.
  • Action
    Cook Medical is initiating the recall of Zilver PTX devices since there is a higher than expected potential of inner delivery catheter breakage due to inconsistencies in the catheter manufacturing process. The recall is intended to address the patient risks that may be associated with the potential failure mode.

Device

Zilver PTX Drug-Eluting Peripheral Stent

Manufacturer

William A Cook Australia Pty Ltd