HALO360 Ablation Catheter

  • Modelo / Serial
    Filter Lot number 78156 was packaged with Catheter Lot numbers: F1012714 , F1012715 , F1012716 , F1012718 , F1012721 , F1012723 , and F1012724, and/or with Sizing Balloon Lot number: F1012719.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
  • Descripción del producto
    Hydrophobic HALO360 Filter that is || packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Barrx Medical, Inc., 540 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • 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