Recall Z-0191-2027 ยท NGV System, Appendage Closure, Left Atrial
Abbott
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034
| Date | Oct 16, 2026 (initiated Sep 10, 2026) |
| Status | Open, Classified |
| Reason | Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). |
| Root cause | Labeling design |
| Action | US IFU was updated and is available via https://manuals.eifu.abbott as of September 4, 2026. The firm began notifying consignees of the updated IFU on September 10, 2026. Abbott asks that physician users continue to follow all procedural steps that have already been provided via training, and that are now included in the IFU, as presented below: " After the landing zone has been identified, assess the closest distance to the pulmonary artery. " A distance =1.5 mm represents significant risk for a pulmonary artery injury; a distance between 1.5 and 3.0 mm represents a theoretical risk for a p |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.