Retiro De Equipo (Recall) de Device Recall Cordis PRECIS (R) Rx 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País 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, carotid - Product Code NIM
  • Causa
    Inability to deploy the stent or partial stent deployment.
  • Acción
    Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 2016, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship¿ To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted. 4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.


  • Modelo / Serial
    Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
  • Descripción del producto
    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
  • Manufacturer


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