Retiro De Equipo (Recall) de Device Recall S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC

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 Cordis Corporation.

¿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
    Stent, iliac - Product Code NIO
  • Causa
    Cordis corporation initiated a recall of s.M.A.R.T. control nitinol iliac stent system due to a potential sterility breach in the pouches.
  • Acción
    All affected consignees were notified by an "Urgent Medical Device Recall (Removal) Letter" dated January 31, 2012 and mailed by overnight delivery on February 1st and 2nd, 2012. Consignees were instructed to identify and quarantine affected product; review, complete, sign, and return an Acknowledgement Form; return the affected product per instructions. Questions should be directed to Customer Service at (800) 551-7683.


  • Modelo / Serial
    Catalog Numbers: C06020ML, C06020SL, C06030ML, C06030SL, C06040ML, C06040SL, C06060ML, C06060SL, C06080ML, C06080SL, C06100ML, C06100SL, C07020ML, C07020SL, C07030ML, C07030SL, C07040ML, C07040SL, C07060ML, C07060SL, C07080ML, C07080SL, C07100ML, C07100SL, C08020ML, C08020SL, C08030ML, C08030SL, C08040ML, C08040SL, C08060ML, C08060SL, C08080ML, C08080SL, C08100ML, C08100SL, C09020ML, C09020SL, C09030ML, C09030SL, C09040ML, C09040SL, C09060ML, C09060SL, C10020ML, C10020SL, C10030ML, C10030SL, C10040ML, C10040SL, C10060ML, C10060SL.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
  • Descripción del producto
    S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T.¿ CONTROL¿ in the logo/description. All unexpired lots from 15112447 through 15525516.
  • Manufacturer


  • Dirección del fabricante
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Empresa matriz del fabricante (2017)
  • Source