Retiro De Equipo (Recall) de Lifestent Vascular Stent System (200 mm stent length)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    After successful introduction of an optimised delivery system design, the device manufacturer angiomed has determined that the optimised lifestent solo vascular stent systems have a significantly lower incidence rate of partial stent deployment associated with their use compared to the original lifestent vascular stent system. the manufacturer, angiomed, has determined that due to the number of lifestent vascular stent system original design devices still available in consignment and customer inventory positions, and the improved performance of the lifestent solo vascular stent system optimized design, a recall action related to the original design product is warranted. this measure will provide customers and patients the lifestent solo optimized stent delivery system performance.
  • Acción
    Customers are requested to inspect their stock and quarantine any product from the affected lots. Bard will arrange for the return and replacement of affected stock. No medical or surgical interventions and no monitoring measures are required for LifeStent Vascular Stents which have already been implanted, as the reported partial stent deployments occurred during the release of the stent from the delivery system.


  • Modelo / Serial
    Lifestent Vascular Stent System (200 mm stent length)Product Code: EX072001L, EX072003L Lots: ANVK0073, ANWB0773, ANWC3759, ANWC3760ARTG: 160453
  • Manufacturer