Events

Retiro De Equipo (Recall) de Flexible Catheter for Circular Cartography Lasso

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 INC;CORDIS SAS.

¿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
    2008-04-03
  • 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/catheter-flexible-pour-les-cartographies-circulaires-lasso-cordis-sas
  • 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
    On 31/03/08 the company CORDIS SAS withdrew from the market all batches of product codes 35O2515R and 35T2515R of the medical device called Flexible Catheter for Lasso Circular Mapping, manufactured by BIOSENSE Webster INC, following the highlighting of the blocking the mechanism of these catheters after complete deflection of the catheter and maximum closure of the loop without the possibility of returning properly to its initial position. The potential risk of these incidents is the difficulty of removing the electrophysiology catheter placed in the right or left atrium to perform the pulmonary vein mapping. The company CORDIS SAS has directly notified the recipients of the incriminated lots to the help message attached (31/03/2008) (32 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The relevant European Competent Authorities have been informed of this measure by the manufacturer.

Device

Flexible Catheter for Circular Cartography Lasso

Manufacturer

BIOSENSE Webster INC;CORDIS SAS