Events

Retiro De Equipo (Recall) de ANASTAFLO INTRAVASCULAR SHUNT

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
    79601
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-14
  • 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
    Through post market surveillance data review edwards lifesciences has identified a potential halth risk to patients undergoing by-pass surgery when an anastaflo intravascular shunt is used. edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. there have been no reports of injuries in any of these complaints.

Device

ANASTAFLO INTRAVASCULAR SHUNT
  • Modelo / Serial
    Model Catalog: IVS1512 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS1530 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2012 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2512 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2030 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2530 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS3030 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    ANASTAFLO INTRAVASCULAR SHUNT
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.