Events

Rappel de Adelante Breezeway

Selon Health Andorra, ce/cet/cette rappel concerne un dispositif en/au/aux/à Andorra qui a été fabriqué par Medtronic.

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
    ARS/2016/11644
  • Date
    2016-11-24
  • Pays de l'événement
    Andorra
  • Source de l'événement
    HA
  • URL de la source de l'événement
    https://www.salut.ad/alertes/alertes.php?_pagi_pg=47&data1=&data2=&tipus=PRODUCTES%20SANITARIS%20-%20Retirada&titol=
  • Notes / Alertes
    Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
  • Notes supplémentaires dans les données

Device

Adelante Breezeway
  • Modèle / numéro de série
  • Description du dispositif
    Sheath alert forward breezeway _oscor
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    HA