Events

Retiro De Equipo (Recall) de Omnilink .018 and .035 Peripheral Stents

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 Guidant.

¿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
    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-des-endoprotheses-vasculaires-peripheriques-omnilink--018-et--035-guidant
  • 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 August 11, 2005, GUIDANT France withdrew from the market all lots currently on the market, medical devices known as Omnilink .018 and .035 peripheral vascular endoprostheses following the receipt of several reports mentioning stents insufficiently fixed on the market. installation device or having migrated during the procedure .. The company has directly notified the recipients of the incriminated lots with the message attached (11/08/2005) (55 KB) validated by Afssaps. information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer.

Device

Omnilink .018 and .035 Peripheral Stents
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM