Onyx Liquid Embolic System

Fabricante

  • 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
    SATP

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Más información acerca de la data acá

  • Modelo / Serial
    Model: All models, Affected: All lots
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ev3 Onyx Liquid Embolic System
  • Manufacturer
    ev3
  • Modelo / Serial
  • Descripción del producto
    Onyx Liquid Embolic System
  • Manufacturer
  • Modelo / Serial
    Onyx Liquid Embolic System (LES), (Used for embolization of intracranial aneurysms and lesions in the peripheral and neurovasculature).Model number(s):105-7000-060/65/80; 105-7200-060/80; 105-8300-500 All Lot numbers affectedARTG Number: 151837
  • Manufacturer