Events

Retiro De Equipo (Recall) de Device Recall Coronary sinus 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 Edwards Lifesciences Llc.

¿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
    57522
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0992-2011
  • Fecha de inicio del evento
    2010-12-03
  • Fecha de publicación del evento
    2011-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96455
  • 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, cannula and tubing, vascular, cardiopulmonary by pass - Product Code DWF
  • Causa
    Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
  • Acción
    The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.

Device

Device Recall Coronary sinus catheter
  • Modelo / Serial
    Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The Steerable Coronary Sinus Catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

Edwards Lifesciences Llc
  • Dirección del fabricante
    Edwards Lifesciences Llc, 12050 Lone Peak Parkway, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA