Events

Rappel de Peripheral self-expanding stents

Selon Federal Service for Surveillance in Healthcare, ce/cet/cette rappel concerne un dispositif en/au/aux/à Russian Federation qui a été fabriqué par Boston Scientific Corporation.

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
    01И-3047/17, РЗН 2013/648
  • Date
    2017-12-07
  • Date de publication de l'événement
    2017-12-08
  • Pays de l'événement
    Russian Federation
  • Source de l'événement
    FSSH
  • URL de la source de l'événement
    http://www.roszdravnadzor.ru/services/unreg
  • Notes / Alertes
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Notes supplémentaires dans les données
    Manufacturer Recall

Device

Peripheral self-expanding stents

Manufacturer

Boston Scientific Corporation
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    FSSH