Retiro De Equipo (Recall) de TAXUS ™ Express2 ™ Monorail®;Express2 ™ Monorail®

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Boston Scientific.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    In agreement with Afssaps, the BOSTON SCIENTIFIC company requested, on July 20, 2004, the health establishments concerned to stop using the TAXUS ™ Express2 ™ Monorail® stent systems and the Express2 ™ Monorail® coronary stent systems on hold a reminder notification of these devices comprising the precise list of the batches concerned, following several cases of non-deflation of the balloon during the stent placement. All health facilities were recipients of the enclosed alert form (21/07/2004) (86 KB). The other European Competent Authorities have been informed of this measure by the manufacturer. Any incident or any risk of serious incident on these devices must be declared within the framework of materiovigilance to the French Agency for the safety of health products - Department of Vigilance - Fax: 01 55 87 37 0. This information concerns Directors of health establishments, local correspondents of materiovigilance and pharmacists of health establishments using these devices for dissemination to the services concerned.


  • Modelo / Serial
  • Descripción del producto
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.”
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