Events

Rappel de ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (CANADA) INC..

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
    25582
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-02-10
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Testing demonstrates a process used to manufacture the inner catheter to stylet joint of the delivery system doesn't meet the required specification on a consistent basis and there is a risk the joint may separate during deployment. a failure of this joint would represent a device malfunction and were it to occur during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention or may result in vessel trauma or an embolic event.

Device

ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
  • Modèle / numéro de série
    Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4265701); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4265701); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4020115); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4470824); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4020115); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4470824)
  • Description du dispositif
    ZILVER VASCULAR STENT WITH RAPID EXCHANGE
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.