Pipeline Embolization Device (Pipeline Classic)

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

3 dispositivos con un nombre similar

Más información acerca de la data acá

  • 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
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    Vascular guide catheter single-use, Peripheral vascular guidewire, Bare-Metal Intracranial Vascular Stent, Intravascular Catheter-Snare
  • Manufacturer
  • Modelo / Serial
  • Clasificación del producto
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Pipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire, UltraFlow HPC Flow Directed Microcatheter and Marathon Flow Directed Microcatheter
  • Manufacturer