Events

Rappel de THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION 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
    25953
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-10-27
  • 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 has observed 34 complaints with a frequency of 0.03% related to a bend/crack at different locations of the shaft of the thermocool smarttouch catheter between january 2012 and july 2014. none of these complaints were associated with adverse events. manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. the purpose of the field safety notice is to reinforce the warnings and precautions and directions for use in the current ifu as well as to notify customers of upcoming updates to the ifu's warnings and precautions.

Device

THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER
  • Modèle / numéro de série
    Model Catalog: D132705 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132704 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132701 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132702 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132703 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133603 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133601 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133602 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Description du dispositif
    THERMOCOOL SMARTTOUCH CATHETER (BI-DIR)
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.