Events

Rappel de Acclarent Inspira Air Balloon Dilation System

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 Acclarent 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
    15287
  • Date de mise en oeuvre de l'événement
    2013-09-11
  • 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
    Reports of difficulty deflating the balloon during a procedure have been received. in each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. the potential for this phenomenon to occur exists in all lots and all sizes of the inspira air balloon dilation system.
  • Action
    Instructions for use to be updated

Device

Acclarent Inspira Air Balloon Dilation System
  • Modèle / numéro de série
    Model: Product Codes: BC0524A, BC0524AZ, BC0724A, BC0724AZ, BC1040A, BC1040AZ, BC1440A, BC1440AZ, Affected: All lots
  • Manufacturer
    Acclarent Inc

Manufacturer

Acclarent Inc