Events

Rappel de Biosense Webster nMARQ Circular Irrigated 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
    18785
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • 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 received an increased number of complaints related to a low temperature measurement anomaly at electrodes of the nmarq® circular irrigated catheter., during the same time period, has also received three reports of deaths of patients who were treated with the nmarq® circular irrigated catheter. two of these cases were confirmed to be caused by atrio-oesophageal fistula., no direct link could be confirmed between the low temperature issue and the atrio-oesophageal fistula as it was detected in only one of the two confirmed cases. therefore, the low temperature issue may be a secondary risk factor as it may affect power titration and delivery during radio frequency ablation.As a result of these issues, biosense webster is recalling the nmarq® circular irrigated catheter and is conducting a full investigation.
  • Action
    Product to be returned to supplier

Device

Biosense Webster nMARQ Circular Irrigated Catheter

Manufacturer

Biosense Webster Inc