Retiro De Equipo (Recall) de Medtronic CryoConsole (A unit that applies a gaseous or liquid refrigerant to withdraw heat from target tissues or indirectly through contact with a cryogen-cooled probe.)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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
    Medtronic has identified a performance issue with a usb memory component that contains some of the system's software within a subset of cryoconsole models. testing indicated that the write speed of the usb memory component from a single supplier lot is slower than those compared to other lots. based on data from field complaints and internal testing, the difference in speed is known to cause the following issues:-1. during inflation of a cryoballon catheter, false detection of balloon deflation and display of system notice 22406 (the balloon is deflated);2. during a procedure, display of system notice 50008 (the system has detected a software error and stopped the injection).No injuries have been reported.
  • Acción
    Users are advised that if a system notice appears, to carefully read and follow the instructions on the screen of the console. A Medtronic representative will also contact users to arrange a service of their CryoConsole system. This action has been closed-out on 18/08/2016.


  • Modelo / Serial
    Medtronic CryoConsole (A unit that applies a gaseous or liquid refrigerant to withdraw heat from target tissues or indirectly through contact with a cryogen-cooled probe.)Models 106A3, 106E2, 106A2-K ARTG Number: 164650
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source