Events

Rappel de Auxiliary cardiac device

Selon Korean Food & Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à South Korea qui a été fabriqué par Medtronic Korea.

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
    733
  • Date
    2017-10-27
  • Pays de l'événement
    South Korea
  • Source de l'événement
    KFDA
  • URL de la source de l'événement
    https://emed.mfds.go.kr
  • Notes / Alertes
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug 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 South Korea.
  • Notes supplémentaires dans les données
    No. 13-3075

Device

Auxiliary cardiac device
  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Used for patients at risk of death due to terminal heart failure (left ventricle, right ventricle). It is designed to be discharged after the procedure and to be able to do everyday life.
  • Manufacturer
    Medtronic Korea

Manufacturer

Medtronic Korea
  • Adresse du fabricant
    Seoul, Korea 534 Teheran-ro, Gangnam-gu, Seoul
  • 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
    KFDA