Retiro De Equipo (Recall) de Twin-Pass dual access catheters

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pyramed 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 II
  • 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
    An investigation of twin-pass units has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or inside the distal part of the rapid exchange lumen of twin-pass dual access catheters. it is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of an embolism to the patient. there have been no reports of injuries associated with this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Pyramed has advised users to quarantine and return the affected devices. This action has been closed-out on 11/11/2016.


  • Modelo / Serial
    Twin-Pass dual access cathetersModel Number: 5200Multiple lot numbers affectedSupplied through the Special Access Scheme (SAS)
  • Manufacturer