TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
- Why
- Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
- Distributed
- Worldwide - US Nationwide distribution.
- Company
- Abbott
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0191-2027 · retrieved 16 October 2026
Read the official notice