Events

Rappel de Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-00965-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-09-12
  • 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-2013-RN-00965-1
  • 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
    Customer complaints reported that the smarttouch catheters were not irrigating correctly during ablation and often resulted in temperature increases and generator shut-off. an internal investigation identified that there is polyimide delamination of the inner lumen surface that can lead to occlusion of the irrigation fluid lumen. insufficient or lack of irrigation (occlusion) can potentially increase the risk of char or thrombus formation at the tip of ablation catheter, which may lead to thromboembolic events, such as stroke.
  • Action
    Customers are asked to quarantine the affected product remaining in the market and return it to Johnson & Johnson Medical Pty Ltd.

Device

Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directiona...
  • Modèle / numéro de série
    Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All lots manufactured prior to August 30, 2013ARTG Numbers: 184035 & 198574
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd