Retiro De Equipo (Recall) de Temporary Transvenous Pacing Lead System Model 6416

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 I
  • 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 that the temporary transvenous pacing lead system is not compliant with section of iec 60601-1, and corresponding provisions of fda 21 cfr 898, which relate to design standards to prevent connecting a patient’s lead to a possible hazardous voltage.
  • Acción
    Medtronic is advising users to identify and quarantine all unused, affected product and return to Medtronic. For patients who have previously received treatment using a Model 6416 lead affected by this recall no action is necessary. Patients who are currently receiving treatment should continue to be managed with your standard patient management protocol and per the product labelling warnings and precautions section.


  • Modelo / Serial
    Temporary Transvenous Pacing Lead System Model 6416 Five (5) PackModel Numbers: 6416-100, 6416-140, 6416-200Single PackModel Numbers: 6416-100S, 6416-140S, 6416-200SManufactured after 1 May 2014ARTG Number: 158765
  • Clasificación del producto
  • 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