Events

Retiro De Equipo (Recall) de INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE

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
    149686
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-08
  • 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
    Edwards lifesciences has identified a potential safety risk which may occur during the use of the intraclude intra-aortic occlusion device (icf100) used in cardiopulmonary bypass surgery. edwards has received a limited number of reports regarding device damage on the strain relief near the hub area. some of the reports have also indicated blood leakage in this area. when damage exists blood loss can occur because blood can fill the device between the lumen shaft and the strain rerlief and leak from the area. no injuries or blood transfusions have been reported. in a worst case scenario with no mitigation blood loss can occur during use of the device.

Device

INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
  • Modelo / Serial
    Model Catalog: ICF100 (Lot serial: ALL)
  • Descripción del producto
    INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.