Events

Retiro De Equipo (Recall) de Medtronic guide catheter 110 cm;Medtronic Guide Catheter 100 cm

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 Medtronic France 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
    2006-04-14
  • 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-catheter-guide-medtronic
  • 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    The company Medtronic France SAS has withdrawn from the market on April 12, 2006, the references and lots, list (12/04/2006) (19 KB) is detailed in the appendix, medical devices called "Medtronic guide catheter 110 cm" and "Medtronic Guide Catheter 100 cm" packaged in 110 cm pockets. This decision follows the detection, during integrity tests, of a risk of micro-holes in the catheter packaging that could create a breach in the sterile barrier of the catheter. The company has directly notified the recipients of the offending lots by means of the attached message (12/04/2006) (17 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer. .. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned.

Device

Medtronic guide catheter 110 cm;Medtronic Guide Catheter 100 cm

Manufacturer

Medtronic France SAS
  • Source
    LAANSM