Retiro De Equipo (Recall) de Functional Anaesthetic Discography (F.A.D.) Catheter System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Kyphon Inc.

¿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
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter System - Product Code BSP
  • Causa
    Guidewire breakages: during the functional anaesthetic discography (f.A.D.) procedure.
  • Acción
    A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.


  • Modelo / Serial
    Lot Numbers: J6033012 and J6013102
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.
  • Descripción del producto
    Functional Anaesthetic Discography (F.A.D.) Catheter || System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
  • Manufacturer


  • Dirección del fabricante
    Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • 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