Events

Rappel de FlexStent Femoropopliteal Self-Exanding Stent 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 Flexible Stenting Solutions 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
    14584
  • Date de mise en oeuvre de l'événement
    2013-05-02
  • 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: Endoventure Ltd, 2/1 Esmonde Road, Takapuna, Auckland
  • Cause
    Manufacturer has determined that during internal package integrity testing, following transportation simulation challenge, the sterile barrrier of the pouch (inner pouch) of some units of the flexistent could be compromised.And to a lesser degree, the outer pouch., to date no complaints associated with this potential mode of failure have been reported., in the event a hole or a tear in the clear film side of the pouch of the affected product is present and both pouches are affected, loss of the sterile barrier could occur, leading to use of a non-sterile device in the procedure.
  • Action
    Product to be returned to supplier

Device

FlexStent Femoropopliteal Self-Exanding Stent System

Manufacturer

Flexible Stenting Solutions Inc