Retiro De Equipo (Recall) de Device Recall TrailBlazer Support Catheter

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 Ev3, 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 1
  • 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
    Percutaneous Catheter - Product Code DQY
  • Causa
    Catheter may crack near the radiopaque marker band at the distal end of the device during use. cracking of the catheter shaft in this location can result in material separation, and potential embolization.
  • Acción
    Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700.


  • Modelo / Serial
    Lot #: 7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, and 7832205.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI.
  • Descripción del producto
    TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. || US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, || SC-014-150, SC-018-150, SC-035-090, and SC-035-150. || Intended to guide and support a guide wire during access of the vasculature.
  • Manufacturer


  • Dirección del fabricante
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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