Events

Rappel de HEART VENT CATHETER ATRIAL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par EDWARDS LIFESCIENCES (CANADA) 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
    49929
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-10-14
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Edwards lifesciences has identified a potential patient safety risk which may occur during the use of venting catheters. the malleable stylet which aids during insertion of the vent catheter is coated with a white plastic. the white plastic on the stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. this can result in the disruption of the white plastic coating on the stylet. there is an increased chance of generating particulate if he stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. reinsertion may lead to an increased potential for particulate to enter the vasculature. no injury has been associated with the use of this device. as a result edwards is adding warnings to the instructions for use included with the affected device models.

Device

HEART VENT CATHETER ATRIAL
  • Modèle / numéro de série
    Model Catalog: E060 (Lot serial: ALL LOTS WITHIN EXPIRY); Model Catalog: PE062 (Lot serial: ALL LOTS WITHIN EXPIRY); Model Catalog: E061 (Lot serial: ALL LOTS WITHIN EXPIRY)
  • Description du dispositif
    HEART VENT CATHETER ATRIAL
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.