Events

Retiro De Equipo O Alerta De Seguridad para Biological heart valves with accessories: Mosaic Aortic abdurator

Según Ministry of Health of the Republic of Belarus, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Belarus que fue producido por Medtronic Inc. (Medtronic Heart Valves Division, Medtronic CoreValve, LLC), UNITED STATES OF AMERICA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    ИМ-7.97407/1401
  • Fecha
    2014-03-02
  • País del evento
    Belarus
  • Fuente del evento
    MHRB
  • URL de la fuente del evento
    https://www.rceth.by/ru/Safety/MedSafety
  • Notas / Alertas
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Notas adicionales en la data
  • Causa
    Medtronic, inc. has initiated a review of the mosaic aortic abturator (model 7305), due to the higher-than-expected transvalvular gradients occurring after implantation.

Device

Biological heart valves with accessories: Mosaic Aortic abdurator

Manufacturer

Medtronic Inc. (Medtronic Heart Valves Division, Medtronic CoreValve, LLC), UNITED STATES OF AMERICA
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    MHRB