Events

Rappel de Biosense ThermoCool SF NAV Uni-directional Catheter

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Biosense Webster 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
    16575
  • Date de mise en oeuvre de l'événement
    2014-05-23
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    The manufacturer has revised the procedural steps and precautions set out in the ifu, 1. when using the devices with conventional systems (using fluroscopy to determine catheter tip location) or with the carto ep navigations system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade., 2. do not use the temperature sensor to monitor tissue temperature., 3. precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the oesophagus to minimse risk of atrio-esophageal fistula.
  • Action
    Instructions for use to be updated

Device

Biosense ThermoCool SF NAV Uni-directional Catheter

Manufacturer

Biosense Webster Inc