| TGA Action ID |
RC-2025-RN-00840-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FREDX 27 Flow Div 4.5mm Diam WL 18/25mm - Flow Re-Direction Endoluminal Device
Product code: XFRED4518
Lot number: 0000663074 |
| ARTG Number |
432290 |
| Unique Device Identifier (UDI) |
FRED X Flow Re-Direction Endoluminal Device |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Problems related to tantalum length and/or tantalum attachment pattern have been identified.
Incorrect tantalum wire length and tantalum wire attachment patterns in a stent may, in turn, lead to delivery and/or deployment problems when implanting the device during surgical procedure.
This could cause procedural delays if a device does not deploy correctly, since the physician would need to recapture the device and withdraw the delivery system and microcatheter together. |
| Instructions for Customers/Users |
- Customers are to immediately check their inventory and return affected stock including consigned stock.
- Replacement stock will be provided by Life Healthcare.
This action has been closed out on 21/01/2026 |
| Action Commencement Date |
2/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 168 - Life Healthcare |