Events

Retiro De Equipo (Recall) de ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOK (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
    35462
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-28
  • 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
    Involve difficulty deploying the graft from the delivery system and/or using the handle portion of the device. no adverse events have been experienced/reported though the potential for adverse events due to deployment difficulties includes additional intervention up to and including open surgical repair. this failure mode applies only to the delivery system and not the implantable stent graft portion of the device. previously implanted grafts are not affected.

Device

ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT
  • Modelo / Serial
    Model Catalog: ZIMB-32-98 (Lot serial: F4779612); Model Catalog: ZIMB-36-108 (Lot serial: F4779612); Model Catalog: ZIMB-32-108 (Lot serial: F4779612); Model Catalog: ZIMB-36-128 (Lot serial: F4779629); Model Catalog: ZIMB-36-118 (Lot serial: F4779629); Model Catalog: ZIMB-36-108 (Lot serial: F4779629); Model Catalog: ZIMB-32-98 (Lot serial: F4779629); Model Catalog: ZIMB-32-84 (Lot serial: F4779629); Model Catalog: ZIMB-32-108 (Lot serial: F4779629); Model Catalog: ZIMB-36-128 (Lot serial: F4779628); Model Catalog: ZIMB-36-118 (Lot serial: F4779628); Model Catalog: ZIMB-36-108 (Lot serial: F4779628); Model Catalog: ZIMB-32-98 (Lot serial: F4779628); Model Catalog: ZIMB-32-84 (Lot serial: F4779628); Model Catalog: ZIMB-32-108 (Lot serial: F4779628); Model Catalog: ZIMB-36-128 (Lot serial: F4779632X); Model Catalog: ZIMB-36-118 (Lot serial: F4779632X); Model Catalog: ZIMB-36-108 (Lot serial: F4779632X); Model Catalog: ZIMB-32-98 (Lot serial: F4779632X); Model Catalog: ZIMB-32-84 (Lot serial: F4779632X); Model
  • Descripción del producto
    ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.