Events

Retiro De Equipo (Recall) de NOVAFLEX 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
    83456
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2011-05-05
  • 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
    An inability to articulate the novaflex delivery system may lead to procedural complications including vessel perforation and potentially patient death. due to a change in manufacturing processes instituted at edwards in august 2010 there are reasonable grounds that all novaflex units manufactured after this date will function as intended. although it is believed the likelihood that other units have been impacted is very low edwards is recalling all novaflex delivery systems manufactured before august 2010 in order to eliminate this risk.

Device

NOVAFLEX DELIVERY SYSTEM
  • Modelo / Serial
    Model Catalog: 9350FS23 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 9350FS26 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    NOVAFLEX DELIVERY SYSTEM
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.