| TGA Action ID |
RC-2026-RN-00816-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Abre Venous Self-Expanding Stent System
All Model Numbers
All Lot Numbers |
| ARTG Number |
448908 |
| Unique Device Identifier (UDI) |
See appendix A of the letter |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Medtronic is updating the Instructions for Use (IFU) for the Abre Venous Self-Expanding Stent System. This update provides a validated manual deployment work around method to help mitigate potential harms in the rare event they experience a partial stent deployment.
As of 14 September 2026, Medtronic reported 31 partial stent deployments (0.015%): 27 caused no or negligible harm, while four required further intervention or treatment.
There are no product retrievals or disposals requested by Medtronic as part of this IFU update. |
| Instructions for Customers/Users |
Customers are asked to review the upcoming updates to the IFU in the customer letter and share this notice with all those who need to be aware.
A link to a video demonstration of the Deployment Workaround Method can befound in the customer letter. |
| Action Commencement Date |
13/10/2026 |
| Responsible Entity |
|
| Contact Information |
0427 456 645, Paul Young or paul.m.young@medtronic.com |