Events

Retiro De Equipo (Recall) de VNUS 7F ClosureFAST 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 VNUS Medical Technologies 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
    45510
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0542-2008
  • Fecha de inicio del evento
    2007-08-08
  • Fecha de publicación del evento
    2008-01-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65695
  • 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 - Product Code GEI
  • Causa
    Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
  • Acción
    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.

Device

VNUS 7F ClosureFAST Catheter
  • Modelo / Serial
    Lot #s:  319484,  274119,  274900,  275146,  275637,  276054,  277311,  277775,  278742,  279181,  279614,  279880,  279938,  280314,  280315,  280316,  285851,  286800,  287108,  287566,  288293,  292135,  292432,  293002,  293275,  293276,  293830,  293832,  294657,  294881,  294882,  295263,  296973,  298603,  299607,  299929,  300573,  301032,  301354,  302329,  302628,  303250,  303712,  303723,  304640,  304698,  305533,  305894,  306571,  306834,  307366,  307561,  307938,  307951,  308465,  309081,  309441,  309741,  309782,  310338,  310401,  310408,  310920,  311185,  312220,  312241,  312334,  313084,  313104,  313373,  313530,  313792,  314079,  314241,  314548,  314655,  315253,  315389,  315751,  315765,  315913,  315922,  316405,  316652,  316653,  316947,  317041,  317342,  317421,  318802,  319117, and  319253
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide
  • Descripción del producto
    VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
  • Manufacturer
    VNUS Medical Technologies Inc

Manufacturer

VNUS Medical Technologies Inc
  • Dirección del fabricante
    VNUS Medical Technologies Inc, 5799 Fontanoso Way, San Jose CA 95138-1015
  • 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