Events

Rappel de THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL 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
    55695
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-09-13
  • 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 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
  • Modèle / numéro de série
    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:
  • Description du dispositif
    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.