Retiro De Equipo (Recall) de Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & Hyperglide Occlusion Balloon Catheters and Guidewires (Supplied in Procedure Packs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por EV3 Australia Pty Limited.

¿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
    There is a regulatory compliance issue where the guidewires were included in the australian register of therapeutic goods (artg) as class iia medical device. they should have been included as class iii. the hyperform and hyperglide occlusion balloon catheters, which are currently supplied in procedure packs also contain one of the above-mentioned guidewires. it has come to the attention of ev3 that these systems have not been included in the artg.
  • Acción
    Quarantine affected stock. The use of affected microcatheters should be only limited to patients eligible under the Special Access Scheme.


  • Modelo / Serial
    Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & Hyperglide Occlusion Balloon Catheters and Guidewires (Supplied in Procedure Packs)
  • 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