Events

Retiro De Equipo (Recall) de Device Recall Zilver 518RX Vascular Stent

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 Cook Medical Incorporated.

¿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
    72965
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0689-2016
  • Fecha de inicio del evento
    2015-12-22
  • Fecha de publicación del evento
    2016-01-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142598
  • 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
    Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. failure of this joint during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event.
  • Acción
    Cook Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 22, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235. On 2/5/2016 a second recall notification was sent to affected consignees, expanding the recall to All Lots of the affected product.

Device

Device Recall Zilver 518RX Vascular Stent
  • Modelo / Serial
    Catalog Prefix ZIVX5. All Lots
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Worldwide
  • Descripción del producto
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
  • Manufacturer
    Cook Medical Incorporated

Manufacturer

Cook Medical Incorporated
  • Dirección del fabricante
    Cook Medical Incorporated, 400 N Daniels Way, Bloomington IN 47404-9155
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA