Events

Retiro De Equipo (Recall) de Pipeline Embolization (Pipeline classic), Alligator Retrieval , Marathon Flow Directed Microcatheter (with Sword), UltraFlow HPC Flow Directed Microcatheter (with Stylix) and Xcelerator Hydrophilic Guidewire

Según National Organization for Medicines, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Greece que fue producido por Micro Therapeutics, Inc., USA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá

Device

Pipeline Embolization (Pipeline classic), Alligator Retrieval , Marathon Flow Directed Microcath...
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Recovery of the Pipeline Embolization Device (Pipeline classic), Alligator Retrieval Device, Marathon Flow Directed Microcatheter (with Sword), UltraFlow HPC Flow Directed Microcatheter (with Stylix) and Xcelerator Hydrophilic Guidewire
  • Manufacturer
    Micro Therapeutics, Inc., USA

Manufacturer

Micro Therapeutics, Inc., USA
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    NOM