| TGA Action ID |
RC-2025-RN-00854-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Axonics Sacral Neuromodulation (SNM) System Tined Lead Kit
Model: 1201 |
| ARTG Number |
297953 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Some users may experience difficulty advancing the tined lead through the introducer sheath during implantation, requiring device exchange during the procedure.
Investigation determined that difficulty advancing the lead may be due to the amount of adhesive applied to the tine component during manufacturing, which may prevent them from fully deflecting within the sheath.
Boston Scientific has since introduced controls to prevent this problem occurring in the future. This problem only affects sheath compatibility; the performance of implanted tined lead devices is not affected. |
| Instructions for Customers/Users |
- When performing procedures, customers are recommended to have back-up/replacement kits on hand to exchange the device, either through their own inventory or from a Boston Scientific Sales Representative’s Assigned Inventory (SRAI), in case this problem is encountered. This will ensure procedures can be completed.
- If the Tined Lead is found to be affected by this problem, please segregate and contact Boston Scientific for a replacement or credit.
This action has been closed out on 02/01/2026 |
| Action Commencement Date |
9/10/2025 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific |