Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37528 |
| Brand Name: | Amulet LAA Occluder Abbott Medical |
| Model: | AMPLATZER TM AmuletTM Left Atrial |
| Affected: | (Models: 9-ACP2-007-0_ _ ; 9-ACP2-010-0_ _ ) |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | Abbott Medical (USA) |
| Issue: | 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.” The manufacturer is updating this contraindication to specifically identify the pulmonary artery as one of the adjacent structures. In addition, the manufacturer is updating the IFU to include additional guidance about assessing the distance between the device landing zone and the pulmonary artery. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 14/9/2026 |
