Abbott recalls Amplatzer Amulet Left Atrial Appendage Occluder
- Recalling company
- 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 II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 10, 2026
- Reported
- Oct 28, 2026
- Distribution
- Worldwide - US Nationwide distribution.
- Status
- Ongoing
- Lot / codes
- UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
- Company location
- Plymouth, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0191-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0191-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.