| TGA Action ID |
RC-2026-RN-00686-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Amplatzer Amulet Left Atrial Appendage Occluder
Model Numbers: 9-ACP2-007-016, 9-ACP2-007-018, 9-ACP2-007-020, 9-ACP2-007-022, 9-ACP2-010-025, 9-ACP2-010-028, 9-ACP2-010-031, 9-ACP2-010-034 |
| ARTG Number |
345210 |
| Unique Device Identifier (UDI) |
9-ACP2-007-016/018/020/022 - 00811806013459, 00811806013466, 00811806013473, 00811806013473, 9-ACP2-010-025/028/031/036 - 00811806013497, 00811806013503, 00811806013510, 00811806013527 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The Instructions For Use (IFU) for the Amplatzer Amulet Left Atrial Appendage Occluder (referred to as Amulet) is being updated to bring attention to the risk of perforation of the pulmonary artery. Pulmonary artery injury is a serious adverse event that can result in pericardial effusion, cardiac tamponade, and potentially death.
The current Amulet IFU contains a contraindication against use “where placement of the device would interfere with any intracardiac or intravascular structures.” Abbott is updating this contraindication to specifically identify the pulmonary artery as one of the adjacent structures. In addition, Abbott is updating the IFU to include additional guidance about assessing the distance between the device landing zone and the pulmonary artery. |
| Instructions for Customers/Users |
Customers are to continue to follow all procedural steps, including assessing the closest distance to the pulmonary artery, as per the updated IFU and advice provided in the customer letter. Abbott also recently completed additional physician training on this subject.
The updated IFU will be available at https://manuals.eifu.abbott |
| Action Commencement Date |
14/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 839 259 - Abbott Medical Australia |