Rappel de FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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
  • ID de l'événement
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Medtronic is advising of an update to the medtronic flexcath advance steerable sheath, instructions for use (ifu). this ifu revision incorporates current best practices for minimising the potential for air ingress and the risk of air embolism.The ifu update includes additional language emphasising minimisation of catheter exchanges, proper aspiration and flushing techniques, and slow advancement and withdrawal of catheters through the sheath.There are no changes to the management of patients who have been or will be ablated with a system using a flexcath advance steerable sheath. it continues to perform as expected in relation to the potential for haemostatic valve leak. this failure mode is monitored and the occurrence rate has been stable over time. as of 31-august-2017, 79 reports of adverse events have been reported out of more than 255,800 devices distributed worldwide. one catastrophic event, associated with death, may have been related to this issue.
  • Action
    Medtronic is providing users with a supplement the FlexCath Advance Steerable Sheath IFU to highlight the known risk of air embolism more prominently. These updates do not impact current clinical practice as this information is consistent with current training and education materials.


  • Modèle / numéro de série
    FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)Model Number: 4FC12All Lot NumbersARTG Number: 213965
  • Manufacturer


  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source