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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00965-1
Product Name/Description Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)

Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603

All lots manufactured prior to August 30, 2013

ARTG Numbers: 184035 & 198574
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/09/2013
Responsible Entity Johnson & Johnson Medical Pty Ltd
Reason/Issue Customer complaints reported that the SmartTouch catheters were not irrigating correctly during ablation and often resulted in temperature increases and generator shut-off. An internal investigation identified that there is polyimide delamination of the inner lumen surface that can lead to occlusion of the irrigation fluid lumen. Insufficient or lack of irrigation (occlusion) can potentially increase the risk of char or thrombus formation at the tip of ablation catheter, which may lead to thromboembolic events, such as stroke.
Recall Action Recall
Recall Action Instructions Customers are asked to quarantine the affected product remaining in the market and return it to Johnson & Johnson Medical Pty Ltd.
Contact Information 1800 252 194 - Johnson & Johnson Medical Customer Service