Events

Retiro De Equipo (Recall) de EDWARDS COMMANDER DELIVERY SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por EDWARDS LIFESCIENCES (CANADA) INC..

¿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
  • ID del evento
    62231
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-13
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The balloon lock mechanism on the handle of the edwards commander delivery system may not fully engage to the balloon catheter during the fine adjustment part of the alignment procedure. this has the potential to result in the inability to position the valve between the valve alignment markers. deploying the valve when it is not between the valve alignment markers may result in suboptimal valve deployment.

Device

EDWARDS COMMANDER DELIVERY SYSTEM
  • Modelo / Serial
    Model Catalog: 9610TF29 (Lot serial: ALL); Model Catalog: 9610TF20 (Lot serial: ALL); Model Catalog: 9610TF23 (Lot serial: ALL); Model Catalog: 9610TF26 (Lot serial: ALL)
  • Descripción del producto
    EDWARDS COMMANDER DELIVERY SYSTEM
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.