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

Class II

Recalling firm: Abbott
Reason for recall: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Affected products (lot / model / serial): UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
Distribution pattern: Worldwide - US Nationwide distribution.
Firm location: Plymouth, MN, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-0191-2027
Recall initiated: September 10, 2026
FDA classification date: October 16, 2026
FDA report date: October 28, 2026
FDA event ID: 99844
Last updated on HTM Vibe: November 3, 2026