Events

Retiro De Equipo (Recall) de PTCA catheter batches

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 CORDIS.

¿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
    2004-07-16
  • 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/retrait-de-lots-de-catheters-de-ptca-de-la-societe-cordis
  • 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, CORDIS withdraws from the market the references and batches specified in the attached list (16/07/2004) (44 KB) of the medical device known as "dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA)". AQUA T3 "following the identification of certain catheters that do not have a sufficient internal coating on the body of the extruded tubing, which may cause difficulties during the procedure, such as difficulty in removing the stylet, moving the guide or loosening pressure. No reports have been reported in France to date. The health facilities concerned by this recall are notified directly by CORDIS SAS by means of the attached message (16/07/2004) (40 KB).

Device

PTCA catheter batches
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    CORDIS

Manufacturer

CORDIS