Abbott: System, Appendage Closure, Left Atrial
Recall Summary Abbott is recalling certain Amplatzer Amulet Left Atrial Appendage Occluder devices used to close a heart chamber opening due to updated safety instructions regarding the risk of pulmonary artery injury during implantation. The recall affects eight specific model numbers of the device that were distributed nationwide across all U.S. states. People who have received this device implanted should consult their healthcare provider about the updated instructions.
- Recalling firm
- Abbott
- Product
- 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
- Reason
- Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7761f9ff-4636-40cb-8cbb-022de1ee89d0