FDA-Device2026-10-16Class IIMISBRANDING
Abbott Amplatzer Amulet Left Atrial Appendage Occluder needs updated instructions for pulmonary artery injury risk
What this means
Abbott has updated the instructions for use for certain Amplatzer Amulet left atrial appendage occluder devices to address a risk of pulmonary artery injury during the procedure. This is a precautionary update affecting multiple model numbers across all lots and serial numbers.
- If you have had this device implanted, contact your cardiologist or implanting physician to discuss the updated safety information.
- Healthcare providers should review the updated instructions before performing any new procedures with affected model numbers.
- Do not discard devices; follow guidance from Abbott and your healthcare facility.
The agency's original wording
Hazard
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Manufactured in
5050 Nathan Ln N, Plymouth, Minnesota, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0191-2027Want us to check the next one for you?
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