Retiro De Equipo (Recall) de MindFrame Capture LPAll

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 the potential for an issue with all mindframe capture lp devices to partially detach or separate from the delivery wire.
  • Acción
    For affected product that has not been used, Medtronic is advising users to quarantine all unused affected product to prevent further use and return them. A Medtronic representative can assist in facilitating the return of product as necessary. In situations where the MindFrame Capture LP device stent or stent fragments have been retained, Medtronic is unable to provide specific patient management recommendations at this time due to patient variability associated with these situations. Medtronic is investigating if recommendations can be made to mitigate potential risks associated with this situation and will contact users as soon as possible when these recommendations, if any, become available.


  • Modelo / Serial
    MindFrame Capture LPAll Models Affected (unexpired product numbers: 300010, 300011, 300012, 300013,300014, 300015, 300016, 300017, 300018)All Lot Numbers Affected.ARTG Number: 283135(Medtronic Australasia - Mindframe Capture LP Revascularization Device - Embolectomy/thrombectomy suction catheter)
  • 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