Events

Rappel de EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BOSTON SCIENTIFIC 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
    29554
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-12-21
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Boston scientific is implementing this medical device correction on certain lots of the express ld biliary stent due to incorrect electronic directions for use (e-dfu) impacting canada only. the e-dfu card included with these products refers to the u.S. e-dfu on the boston scientific e-labeling website which currently contains indications that are not approved by health canada. no adverse health consequence is reasonably expected to occur and no complaints have been received to date.

Device

EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM
  • Modèle / numéro de série
    Model Catalog: H74938046530750 (Lot serial: 19544802); Model Catalog: H74938046530750 (Lot serial: 19808367); Model Catalog: H74938046530750 (Lot serial: 19394085); Model Catalog: H74938046530750 (Lot serial: 18032680); Model Catalog: H74938046530750 (Lot serial: 19472345); Model Catalog: H74938046530750 (Lot serial: 17922271); Model Catalog: H74938046530750 (Lot serial: 19200184); Model Catalog: H74938046530750 (Lot serial: 19321955); Model Catalog: H74938046530750 (Lot serial: 18032682); Model Catalog: H74938046530750 (Lot serial: 18068984)
  • Description du dispositif
    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM
  • Manufacturer
    BOSTON SCIENTIFIC LTD.

Manufacturer

BOSTON SCIENTIFIC LTD.
  • Adresse du fabricant
    MISSISSAUGA
  • 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
    HC