Retiro De Equipo (Recall) de Celsius Thermocool catheters;Navistar Thermocool catheters

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 BIOSENSE WEBSTER.

¿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
    2005-08-12
  • País del evento
  • Fuente del evento
    ANSM
  • 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
    The company BIOSENSE WEBSTER has withdrawn from the market on 10/08/05 batches 13027030 to 13044734 of the medical device called ablation catheters Celsius Thermocool and batches 13027030 to 13044642 of the medical device called ablation catheters Navistar Thermocool following the implementation evidence of an insufficient amount of polyurethane in some catheters that would cause variations in irrigation flow (cases of leakage or occlusion of irrigation fluid have been described). The company has directly notified the recipients of the incriminated lots with the attached message (10/08/2005) (32 KB) validated by Afssaps. This information is addressed to the directors of health facilities and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The competent European authorities concerned are informed of this measure by BIOSENSE WEBSTER.

Device

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer

Manufacturer