Events

Rappel de NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)

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
    Recall
  • ID de l'événement
    RC-2013-RN-00973-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • 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-2013-RN-00973-1
  • 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
    Medtronic has identified a labelling issue for lot number 207002011 of the nc sprinter rx balloon dilatation catheter, model ncsp22512x, in which the compliance chart contained inside the package incorrectly references a 2.5mm balloon diameter instead of the correct 2.25mm diameter. if the affected product was utilised referencing the incorrect compliance chart, the target diameter of the balloon may be less than expected, resulting in suboptimal treatment. the situation would require further inflation at a higher pressure or the use of another balloon catheter to resolve the stenosis, resulting in longer procedural duration.
  • Action
    Medtronic is requesting users to return affected stock for replacement with unaffected product.

Device

NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)
  • Modèle / numéro de série
    NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)Model Number: NCSP22512XLot Number: 207002011ARTG 154737
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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
    DHTGA