Device recall
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
- Recall number
- Z-0191-2027
- Event id
- 99844
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Abbott
- Report date
- Oct 28, 2026
- Posted
- Oct 16, 2026
- Initiated
- Sep 10, 2026
- Center classification date
- Oct 16, 2026
- Product code
- NGV
- Device type
- System, Appendage Closure, Left Atrial
- Reason
- Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
- Root cause
- Labeling design
- Code info
- UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
- Distribution
- Worldwide - US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Plymouth, MN, United States