Recall Z-0191-2027— Abbott
Class II · Ongoing
Class II FDA medical device recall by Abbott, initiated 2026-09-10. FDA's recall record names no specific 510(k) clearance for this event. 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)..
- Recalling firm
- Abbott
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-10
- Firm location
- Plymouth, MN, United States
Product description
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 for recall
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Data sourced from openFDA. This site is unofficial and independent of the FDA.