Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23854 |
| Brand Name: | ThermoCool SmartTouch SF Unidirectional |
| Model: | |
| Affected: | Catalogue No's: D134701, D134702, D134703, D134801, D134802, D134803, D134804, D134805 |
| 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: | Thermocool SmartTouch SF Bidirectional catheter |
| Model: | |
| Affected: | Catalogue No's: D134701, D134702, D134703, D134801, D134802, D134803, D134804, D134805 |
| 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 observed a higher than expected reported rate of char formation for the THERMOCOOL SMARTTOUCH® SF Uni-Directional Navigation Catheter and the THERMOCOOL SMARTTOUCH® SF Bi-Directional Navigation Catheter (collectively, the "THERMOCOOL SMARTTOUCH® SF Catheters"). Although char formation by itself is not a patient adverse event, in rare circumstances it has the potential to contribute to patient adverse events. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/11/2018 |
