Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36779 |
| Brand Name: | Radio-frequency ablation system probe cannula, reusable |
| Model: | TCNTM (Thermo Couple Nitinol) |
| Affected: | All batches |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Issue: | The manufacturer has determined that the Thermo Couple Nitinol (TCN) and Cosman Straight Kit (CSK) Reusable RF Electrodes may not consistently meet the expected performance levels throughout the specified 20 sterilisation cycles for re-use. This determination was based on recent review of internal laboratory testing. Complaint data indicates that the most frequently reported problems relate to electrode not heating, temperature-reading problems and device damage, which have led to prolonged procedure. A small number of cases (0.15%) reported unintentional burns, allergic reactions, increased pain, or the need for additional intervention to retrieve potentially unrecovered parts (0.03%) |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/5/2026 |
