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
    25953
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-27
  • 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 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
  • Model / Serial
    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)
  • Product Description
    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.