Events

Retiro De Equipo (Recall) de THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION 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
    55695
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-09-13
  • 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 received an increased number of complaints related to the display of alert 402 on the carto 3 system for certain lots of thermocool brand catheters. alert 402 implies magnetic distortion which may result in inaccurate catheter tip location information. this may lead the physician to ablate in an unintended area when delivering rf energy. the user manual provides steps for resolving this alert but for the lots subject to this recall those steps are not effective. subject lots are therefore being removed.

Device

THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
  • Modelo / Serial
    Model Catalog: D134703 (Lot serial: 17685897L); Model Catalog: D134805 (Lot serial: 17680149L); Model Catalog: D134804 (Lot serial: 17685816L); Model Catalog: D134805 (Lot serial: 17685816L); Model Catalog: D134804 (Lot serial: 17689537L); Model Catalog: D134805 (Lot serial: 17689537L); Model Catalog: D134804 (Lot serial: 17692186L); Model Catalog: D134805 (Lot serial: 17692186L); Model Catalog: D134804 (Lot serial: 17692191L); Model Catalog: D134805 (Lot serial: 17692191L); Model Catalog: D134701 (Lot serial: 17682851L); Model Catalog: D134702 (Lot serial: 17682851L); Model Catalog: D134703 (Lot serial: 17682851L); Model Catalog: D134701 (Lot serial: 17689463L); Model Catalog: D134702 (Lot serial: 17689463L); Model Catalog: D134703 (Lot serial: 17689463L); Model Catalog: D134701 (Lot serial: 17685811L); Model Catalog: D134702 (Lot serial: 17685811L); Model Catalog: D134703 (Lot serial: 17685811L); Model Catalog: D134701 (Lot serial: 17685897L); Model Catalog: D134702 (Lot serial: 17685897L); Model Catalog:
  • Descripción del producto
    THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER;THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
  • 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