| TGA Action ID |
RC-2026-RN-00491-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Balt Hybrid Guidewire
Product Code: HYBRID007J
Lot Number: 00634685
Expiry Date: 28-Dec-2030 |
| ARTG Number |
175484 |
| Unique Device Identifier (UDI) |
03700481334355 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential performance problem affecting the hydrophilic coating of HYBRID007 guidewires manufactured within specific production lots. A coating variability may result in increased friction between the guidewire and the microcatheter during navigation, particularly when used with MAGIC 1.2F/M Balt microcatheters.
In some cases, users may experience increased resistance during device navigation, which could require replacement of the guidewire and may prolong the procedure. This could also increase the risk of vessel injury associated with extended intravascular manipulation.
No patient injuries related to this problem have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and quarantine any units of LOT 00634685 to prevent further use.
- Return stock to the sponsor.
Balt Australia currently has units of unaffected HYBRID007J to be allocated as suitable replacements for any recalled units. Manufacturing process improvements have been implemented to further enhance hydrophilic coating performance and prevent recurrence of the problem.
This action has been closed out on 27/08/2026 |
| Action Commencement Date |
2/07/2026 |
| Responsible Entity |
|
| Contact Information |
07 2111 7995 - Balt Australia Customer Service |