Events

Recall of THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27330
  • Event Risk Class
    I
  • Event Initiated Date
    2013-09-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Biosense webster has identified a defect in the production process of the thermocool smarttouch catheter which can lead to occlusion of the irrigation lumen. an irrigation fluid flow interruption has the potential to lead to overheating of the ablation tip and formation of char or thrombus which in turn could pose a thromboembolic risk to the patient. all lots are being removed from the field.

Device

THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER
  • Model / Serial
    Model Catalog: D132703 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132702 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132701 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132705 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132704 (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)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    THERMOCOOL SMARTTOUCH BI-DIR NAV CATH.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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