Events

Rappel de Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker South Pacific.

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
    RC-2016-RN-00298-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00298-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Stryker neurovascular has become aware that the product labels (pouch and carton) for the neuroform atlas stent catheter contains an incorrect conversion from inches to millimetres for the minimum catheter diameter dimension (0.0165in 0.69 mm). the correct dimensions are 0.0165in (0.42mm). this 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. if this happens, additional procedure/treatment would be required and the patient may be exposed to increased time under anaesthesia.
  • Action
    The sponsor is advising that the affected devices can continue to be used, provided that the correct dimensions listed in the product directions for use (DFU) are followed. This action has been closed-out on 23/01/2017.

Device

Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneury...
  • Modèle / numéro de série
    Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)Item numbers: EZAS3024, EZAS3015, EZAS4015, EZAS4530, EZAS3021, EZAS4521 and EZAS4024.All lot numbersSupplied under the Special Access Scheme
  • Manufacturer
    Stryker South Pacific

Manufacturer

Stryker South Pacific
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA