Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16575 |
| Brand Name: | Biosense ThermoCool SF Nav Bi-Directional Catheter |
| Model: | |
| 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 ThermoCool SF NAV Uni-directional Catheter |
| Model: | |
| 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: | The manufacturer has revised the procedural steps and precautions set out in the IFU 1. When using the devices with conventional systems (using fluroscopy to determine catheter tip location) or with the Carto EP Navigations System, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade. 2. Do not use the temperature sensor to monitor tissue temperature. 3. Precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the oesophagus to minimse risk of atrio-esophageal fistula. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/5/2014 |
