Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18469 |
| Brand Name: | Idoman Thermablate Endometrial Ablation System |
| Model: | Product Codes: 22101 & 21004 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | New Zealand Medical & Scientific Ltd Level 4, Building 10 666 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 09 259 4062 |
| Manufacturer: | Idoman Teoranta |
| Issue: | The Instructions For Use (IFU) of the Thermablate Endometrial Ablation System (EAS) has been updated following four case reports of uterine perforation. There is an increased risk of patient injury (including damage to non-targeted tissue) if both Thermablate EAS procedure and hysteroscopic tubal occlusion/sterilisation are performed on the same day. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 7/5/2015 |
