Events

Rappel de Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

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 Stryker Neurovascular.

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
    19898
  • Date de mise en oeuvre de l'événement
    2016-03-18
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    It was identified that the neuroform atlas pouch and carton label references the incorrect measurement in millimeters for the minimum catheter diameter. the minimum catheter diameter is correctly listed as 0.0165 inches on both product labels, but incorrectly converted to millimetres as 0.69mm. the correct conversion value is 0.42. the labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. the result to the patient being extended procedure/ additional treatment required and increased time under anaesthesia. no adverse health consequences are anticipated. there is no risk to patients associated with previous use of affected devices.
  • Action
    Manufacturer to issue advice regarding use

Device

Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

Manufacturer

Stryker Neurovascular
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA