Events

Retiro De Equipo (Recall) de Biosense PentaRay Catheters

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 Biosense Webster 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
    20076
  • Fecha de inicio del evento
    2016-04-22
  • 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
    Biosense webster is clarifying the contraindication language in the instructions for use (ifu) and product labelling for use of this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray® catheter in patients with prosthetic valves under the contraindication section stating: "[the] use of this catheter may not be appropriate for use in patients with prosthetic valves." the update to the ifu is to clarify the contraindication statement to the following: "do not use pentaray® catheters in patients with prosthetic valves".
  • Acción
    Instructions for use to be updated

Device

Biosense PentaRay Catheters
  • Modelo / Serial
    Model: D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212, Affected: all Lot numbers
  • Manufacturer
    Biosense Webster Inc

Manufacturer

Biosense Webster Inc