Events

Alerte De Sécurité sur EMBOL-X Glide Protection System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Edwards Lifesciences Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-02
  • Date de publication de l'événement
    2013-10-02
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002c.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: edwards lifesciences embol-x glide protection system the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning embol-x glide protection system manufactured by edwards lifesciences ltd. the affected model numbers are exgf24, exgf24ll, exgf24mm, exgf24ss, exgf24xl, exgf24xs. through a complaint investigation, edwards lifesciences has identified a potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the embol-x glide protection system. the reported complaint involved a deformed tip of the cannula that is part of the embol-x glide protection system, this was confirmed during product evaluation. as a result, the manufacturer is recalling all lot numbers of the embol-x glide protection system cannulae that have not expired. no patient injury was reported with the use of this device. the manufacturer believes that risk of injury to patients from this issue is possible; if the defect is not noticed during preparation, when force applied to the tip during insertion or removal, it may lead to a separation and embolize. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

EMBOL-X Glide Protection System

Manufacturer

Edwards Lifesciences Ltd