Onyx Liquid Embolic System

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    HPRA

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  • Modèle / numéro de série
    Model: All models, Affected: All lots
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  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ev3 Onyx Liquid Embolic System
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    ev3
  • Modèle / numéro de série
    All | All
  • Description du dispositif
    MD: Neurovascular embolization implant
  • Manufacturer
  • Modèle / numéro de série
    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