Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16668 |
| Brand Name: | Idoman Thermablate Endometrial Ablation System (EAS) |
| Model: | All devices |
| 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: | Two changes have been made to the Instructions for Use for Thermablate-EAS 1. Physician to conduct a second sounding of the uterus just after dilation and before performing hysteroscopic examination of the uterus to confirm that perforation of the uterus or the creation of a false passage has not occurred during the dilation and soundings. 2. Clarification of contraindications |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 13/5/2014 |
