Events

Retiro De Equipo (Recall) de CARTO XP-THERMOCOOL*SF NAV BI-DIRECTIONAL CATHETER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    33634
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Biosense webster has identified a higher frequency of spontaneously reported adverse events related to cardiac perforations and atrio-esophageal fistula (aef) with the uni-directional and bi-directional thermocool sf nav catheter family during the time period of january 2010 to december 2013 as compared to other navigational thermocool ablation catheters.

Device

CARTO XP-THERMOCOOL*SF NAV BI-DIRECTIONAL CATHETER
  • Modelo / Serial
    Model Catalog: BNI35JJH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35BBH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35BDH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35BFH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35DDH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35DFH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35DJH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35FFH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35FJH (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35FFCT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35FJCT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35DFCT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35DDCT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35BFCT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35BDCT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: BNI35BBCT (Lot serial: >100 NUMBERS CONTAC
  • Descripción del producto
    CARTO XP-THERMOCOOL SF NAV BI-DIRECTION
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC