Events

Rappel de Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific 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-2012-RN-01053-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-29
  • 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-2012-RN-01053-1
  • 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
    Users of the encore 26 advantage kits which were manufactured between august 3 2012 and september 18 2012 may experience difficulty in passing guidewires through the insertion tool which is included in the encore 26 advantage kits. the difficulty to pass guidewires, especially j tipped guidewires, through the insertion tool is caused by lack of smoothness within the hub/hypo tube transition in some devices.
  • Action
    The sponsor is provided work around instructions for users to follow.

Device

Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular ...
  • Modèle / numéro de série
    Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures)Encore 26 Advantage KitMaterial Number: H74904527011Catalogue Number: 04527-01Encore 26 Advantage Kit (5 pack)Material Number: H74904527052Catalogue Number: 04527-05Multiple Lot NumbersExpiration dates between 13 August 2014 & 30 September 2014Manufactured between 3 August 2012 & 18 September 2012ARTG Number: 159833
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA