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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