Events

Retiro De Equipo (Recall) de Acclarent Inspira Air Balloon Dilation 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 Acclarent 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
    15287
  • Fecha de inicio del evento
    2013-09-11
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    Reports of difficulty deflating the balloon during a procedure have been received. in each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. the potential for this phenomenon to occur exists in all lots and all sizes of the inspira air balloon dilation system.
  • Acción
    Instructions for use to be updated

Device

Acclarent Inspira Air Balloon Dilation System
  • Modelo / Serial
    Model: Product Codes: BC0524A, BC0524AZ, BC0724A, BC0724AZ, BC1040A, BC1040AZ, BC1440A, BC1440AZ, Affected: All lots
  • Manufacturer
    Acclarent Inc

Manufacturer

Acclarent Inc