Events

Retiro De Equipo (Recall) de FlexStent Femoropopliteal Self-Exanding Stent System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Flexible Stenting Solutions 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
    14584
  • Fecha de inicio del evento
    2013-05-02
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Endoventure Ltd, 2/1 Esmonde Road, Takapuna, Auckland
  • Causa
    Manufacturer has determined that during internal package integrity testing, following transportation simulation challenge, the sterile barrrier of the pouch (inner pouch) of some units of the flexistent could be compromised.And to a lesser degree, the outer pouch., to date no complaints associated with this potential mode of failure have been reported., in the event a hole or a tear in the clear film side of the pouch of the affected product is present and both pouches are affected, loss of the sterile barrier could occur, leading to use of a non-sterile device in the procedure.
  • Acción
    Product to be returned to supplier

Device

FlexStent Femoropopliteal Self-Exanding Stent System

Manufacturer

Flexible Stenting Solutions Inc