Events

Retiro De Equipo (Recall) de Device Recall CORDIS S.M.A.R.T. Control" Nitinol 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 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
    Recall
  • ID del evento
    47347
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1556-2008
  • Fecha de inicio del evento
    2008-03-10
  • Fecha de publicación del evento
    2008-07-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69267
  • 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
    Iliac Stent - Product Code NIO
  • Causa
    Data transcription error. the 10 affected lots of catalog number c10040sl were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. this condition may result in a separation of the device. if a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel.
  • Acción
    A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.

Device

Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System
  • Modelo / Serial
    10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution --- including USA and countries of Japan and Canada.
  • Descripción del producto
    CORDIS S.M.A.R.T.¿ Control" Nitinol Stent System || Model Number(s): C10040SL, Manufactured in Mexico. || Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Dirección del fabricante
    Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes FL 33014
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA