| TGA Action ID |
RC-2026-RN-00764-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Sharp Uterine Curettes / Gynaecological Curettes
Gynaecological Curettes: Endometrial Biopsy Curettes, Endocervical Biopsy Curettes, Endometrial Sampling Curettes, Uterine Curettes, Placenta Curettes, Uterine Scoops and Placenta Scoops |
| ARTG Number |
299843 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Intrauterine surgical procedures, particularly those involving mechanical trauma to the endometrium, may be associated with the formation of intrauterine adhesions. In clinically significant cases, these adhesions may result in Asherman Syndrome.
The risk may be influenced by the clinical circumstances, including the underlying condition, the extent of endometrial trauma, repeated intrauterine procedures and other patient- or procedure-related factors.
The Instructions for Use (IFU) of the affected devices has been updated to include information regarding intrauterine adhesions and Asherman Syndrome, together with relevant warnings. |
| Instructions for Customers/Users |
Customers are to review and follow the updated IFU supplied with the affected devices. |
| Action Commencement Date |
2/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 756 757 - INKA Surgical |