Events

Retiro De Equipo (Recall) de LeMaitre_14339_IIa_Valvulotome

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 LeMaitre Vascular 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
    21089
  • Fecha de inicio del evento
    2017-02-09
  • 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: Clinical & Regulatory Services Limited, 50B Puketapu Road, Taradale, Napier 4112
  • Causa
    There have been issues of hoops failing to close when the device was actuated. in some cases, this issue has been discovered in-use and has led to vessel damage. if the blades are stuck in the open position, the device must be removed in the open state. the removal of the device without sheathing may cause damage to the vein either during use or when the blades pass the opening of the vessel.
  • Acción
    Product to be returned to supplier

Device

LeMaitre_14339_IIa_Valvulotome

Manufacturer

LeMaitre Vascular Inc