Pipeline Embolization Device

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
    RLMPH

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Más información acerca de la data acá

  • Modelo / Serial
    all codes
  • Descripción del producto
    Pipeline Embolization Device (PED)
  • Manufacturer
  • Modelo / Serial
    this issue affects all lots of the below Neurovascular products that have an expiration date (Use by Date) between June 2017 and August 2019 (please refer to Appendix)
  • Clasificación del producto
  • Descripción del producto
    Vascular guide catheter single-use, Peripheral vascular guidewire, Bare-Metal Intracranial Vascular Stent, Intravascular Catheter-Snare
  • Manufacturer
  • Modelo / Serial
    Sanitary DNM Registration Numbers: IM079130062016, IM031905032015, IM026307042016. PIM number:882014
  • Clasificación del producto
  • Manufacturer
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