Events

Retiro De Equipo (Recall) de PENTARAY NAV ECO HIGH DENSITY MAPPING 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
    54061
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-19
  • 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 is clarifying the contraindication language in the instructions for use (ifu) and product labeling relative to patients with prosthetic valves. the current language states: "[the] use of this catheter may not be appropriate for use in patients with prosthetic valves." biosense webster is updating the ifu to clarify the contraindication statement as follows: "do not use pentaray catheters in patients with prosthetic valves." this action is not a product removal.

Device

PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER
  • Modelo / Serial
    Model Catalog: D128207 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128209 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128210 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128211 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128212 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128208 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128206 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128205 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128201 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128203 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128204 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    PENTARAY NAV ECO HIGH DENSITY CATHETERS;PENTARAY NAV HIGH DENSITY CATHETERS
  • 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