Events

Retiro De Equipo (Recall) de Device Recall Protg EverFlex" SelfExpanding Biliary Stent 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 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
    Recall
  • ID del evento
    55303
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1598-2010
  • Fecha de inicio del evento
    2010-03-31
  • Fecha de publicación del evento
    2010-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90509
  • 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, biliary, diagnostic - Product Code FGE
  • Causa
    Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. they determined that a lot of 120mm prot¿g¿ everflex" biliary stent system may contain a 150mm length self-expanding stent and two lots o 150mm prot¿g¿ everflex" biliary stent system may contain a 120 mm length self-expanding stent.
  • Acción
    ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return. For further information, contact ev3 Customer Service at 1-800-716-6700.

Device

Device Recall Protg EverFlex" SelfExpanding Biliary Stent System
  • Modelo / Serial
    Lot Numbers: 7857377, 7856788 and 7858698.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.
  • Descripción del producto
    ev3 Prot¿g¿ EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. || Intended as a palliative treatment of malignant neoplasms in the biliary tree.
  • Manufacturer
    Ev3, Inc.

Manufacturer

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