| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00127-1 |
| Product Name/Description |
Abre Venous Self-expanding Stent System
Product Number: AB9G14100090
Serial Number/Batch: B460542
Product GTIN: 00763000547325
ARTG 315001
(Medtronic Australasia Pty Ltd - Abre Venous Self-Expanding Stent System - Iliofemoral vein stent) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is initiating a product recall for specific impacted lots of the Abre Venous Self-expanding Stent System due to the potential for sterile package breach. |
| Recall Action |
Recall |
| Recall Action Instructions |
Required Customer Actions:
1. Immediately identify and quarantine all affected and unused Abre Venous Self-expanding Stent System devices as listed in the customer letter.
NB: Please note follow up instructions for retrieval of the device will be communicated by Medtronic for the impacted Abre Venous Self-expanding Stent System devices within the next 2-3 weeks.
2. Please complete and sign the Customer Confirmation form acknowledging
3. Please share this notice with all those who need to be aware within your account and maintain a copy of this notice in your records.
NB: If product has been implanted, follow your normal patient monitoring protocols.
Update March 2024: unused affected product should be returned to Medtronic. The local Medtronic Representative can assist customers with the initiation of the return. |
| Contact Information |
0427456645 or paul.m.young@medtronic.com - Paul Young |