| TGA Action ID |
RC-2025-RN-00153-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Allurion Gastric Balloon System
Model number: 10D-AUS
ARTG 363010
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Balloon, gastric, appetite-suppressing) |
| ARTG Number |
363010 |
| Action Type |
Product Defect Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Allurion has identified new contraindications, controls, and precautions around the use of the Allurion Gastric Balloon System. These have been incorporated into the updated Instructions for Use (IFU). |
| Instructions for Customers/Users |
Customers are to review the updated IFU attached to the customer letter.
The changes include new contraindications, controls and precautions. |
| Action Commencement Date |
27/02/2025 |
| Responsible Entity |
|
| Contact Information |
AUNZvigilance@ul.com - Emergo Australia |