Events

Retiro De Equipo (Recall) de ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT

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
    49223
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-22
  • 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
    A new ifu has been approved with updated information. the updates to the ifu are of key importance when using the device to treat blunt thoracic aortic injury (btai) which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. this safety communication is for informational purposes only and no devices need to be returned.

Device

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT
  • Modelo / Serial
    Model Catalog: ZTA-PT-32-28-178 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-46-233 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-46-179 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-46-125 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-44-233 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-44-179 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-44-125 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-42-225 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-42-173 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-42-121 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-40-217 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-40-167 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-40-117 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-38-217 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-38-167 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-38-117 (Lot serial: >10 contact mfr); Model Catalog: ZTA-P-36-209 (Lot serial: >10 contact mfr); Model Catalog: Z
  • Descripción del producto
    zenith A.T.E. proximal tapered component;zenith A.T.E. proximal component;zenith A.T.E. distal component
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.