Events

Retiro De Equipo (Recall) de Express2 ™ Monorail® TAXUS ™ Stent Systems and Express2 ™ Monorail® Coronary Stent Systems

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
    Recall
  • Fecha
    2004-07-26
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-des-stents-coronaires-express-2-et-taxus-express-2-de-la-societe-boston-scientific
  • 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
    Following several instances of non-deflation of the balloon during stent placement, Boston Scientific is recalling all Express2 ™ Monorail® TAXUS ™ Stent Systems and Express2 ™ Monorail® Coronary Stent Systems prior to corrective actions initiated. by the company in April and May 2004. Initially, on July 20, 200., in agreement with Afssaps, the company BOSTON SCIENTIFIC sent a fax to the health establishments concerned asking them to quarantine the stent systems TAXUS ™ Express2 ™ Monorail® and Express2 ™ Monorail® Coronary Stent Systems awaiting a recall notification of these devices including a precise list of affected lots. On July 23, 2004, the Boston Scientific company sent to the health establishments concerned a letter (26/07/2004) (16 KB) accompanied by a list specific to each establishment specifying the numbers of the lots concerned by the recall. The other European Competent Authorities have been informed of this measure by the manufacturer. Any incident or risk of serious incident on these devices must be declared in the context of materiovigilance to the French Agency for Health Safety of Health Products - Department of Vigilance - Fax: 01 55 87 37 02. This information concerns the directors health facilities, local correspondents for materiovigilance and pharmacists in health facilities using these devices, for dissemination to the services concerned.

Device

Express2 ™ Monorail® TAXUS ™ Stent Systems and Express2 ™ Monorail® Coronary Stent Systems

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • 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.”
  • Source
    LAANSM