Events

Retiro De Equipo (Recall) de ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM

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
    25582
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-10
  • 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
    Testing demonstrates a process used to manufacture the inner catheter to stylet joint of the delivery system doesn't meet the required specification on a consistent basis and there is a risk the joint may separate during deployment. a failure of this joint would represent a device malfunction and were it to occur during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention or may result in vessel trauma or an embolic event.

Device

ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
  • Modelo / Serial
    Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4265701); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4265701); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4020115); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4470824); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4020115); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4470824)
  • Descripción del producto
    ZILVER VASCULAR STENT WITH RAPID EXCHANGE
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.