Events

Rappel de Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Edwards Lifesciences Pty Ltd.

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-2015-RN-00294-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-31
  • 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-2015-RN-00294-1
  • 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
    Through post market surveillance, edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula, sizes 8, 10, and 12 french only. edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use. in a worst-case scenario, if the physician attempted to insert the device, the exposed wire could damage the femoral artery, causing a vascular injury that could require surgical or interventional repair.While there have been no reports of injury associated with this issue, edwards is taking this action to eliminate the chance of tissue damage caused by a protruding wire.
  • Action
    All affected product is being Recalled from the Market. This action has been closed-out on 17/08/2016.

Device

Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French
  • Modèle / numéro de série
    Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 FrenchProduct Codes: FEMII008A, FEMII008AT, FEMII010A, FEMII010AT, FEMII012A & FEMII012ATARTG Number: 177959Product Codes: FEMII008V, FEMII010V & FEMII012VARTG Number: 142782Multiple lot numbers affectedARTG number: 142782
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd