Rappel de LeVeen Coaccess Introducer Set

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States 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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Electrode, electrosurgical - Product Code JOS
  • Cause
    Leveen standard and leveen coaccess needle electrode system, directions for use(dfu) in portuguese, are incorrect. all other languages in the dfu are correct. consignees in brazil, portugal,and hong-kong are being notified.
  • Action
    Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.


  • Modèle / numéro de série
    Material Catalog Number: MOO1262250 with lot numbers: 12303537, 12304530, 12318677, 12376281, 12516197, 12526599, 12564932, 12863427, 12868931, 12900282, 13020097, 13075108, 13093464, 13131129, 13364410, 13487647, 13488797, 13489157, 13563682, 13600249, 13629070, 13659872, 13759829, 13767726, 13892916, 14024827, 14119996, 14141754, 14215317, 14218162, 14218163, 14218164, 14268381, and 14273987.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Distributed in Brazil, Portugal and Hong Kong.
  • Description du dispositif
    Leveen Coaccess Introducer Set. || Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
  • Manufacturer


  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Société-mère du fabricant (2017)
  • 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