Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15358 |
| Brand Name: | Biosence Webster ThermoCool SmartTouch Bi-directional Navigation Catheter |
| Model: | Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Biosense Webster Inc |
| Brand Name: | Biosense Webster ThermoCool SmartTouch Uni-Directional Catheter |
| Model: | Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Biosense Webster Inc |
| Issue: | An investigation identified a defect in the production process which can lead to occlusion of the irrigation fluid lumen. To date, there have been no patient injuries or adverse events reported as a result of this defect. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/9/2013 |
