Events

Rappel de PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    54061
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Description du dispositif
    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.