Class 2 Device Recall Amplatzer Amulet

• Date Initiated by Firm: September 10, 2026
• Date Posted: October 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0191-2027
• Recall Event ID: 99844
• PMA Number: P200049
• Product Classification: System, appendage closure, left atrial - Product Code NGV
• 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
• Code Information: UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
• FEI Number: 3005334138
• Recalling Firm/ Manufacturer: Abbott; 5050 Nathan Ln N; Plymouth MN 55442-3209
• For Additional Information Contact: Shelley Lange; 612-346-3514
• Manufacturer Reason for Recall: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
• FDA Determined Cause: Labeling design
• Action: US IFU was updated and is available via https://manuals.eifu.abbott as of September 4, 2026. The firm began notifying consignees of the updated IFU on September 10, 2026. Abbott asks that physician users continue to follow all procedural steps that have already been provided via training, and that are now included in the IFU, as presented below: " After the landing zone has been identified, assess the closest distance to the pulmonary artery. " A distance =1.5 mm represents significant risk for a pulmonary artery injury; a distance between 1.5 and 3.0 mm represents a theoretical risk for a pulmonary artery injury; and a distance >3.0 mm represents a lower risk for a pulmonary artery injury. " To reduce the risk of pulmonary artery injury, consider an alternative landing zone or device orientation when clinically appropriate and C.L.O.S.E. criteria can still be met. " If the risk of pulmonary artery injury cannot be adequately minimized, the physician should carefully consider whether to proceed with device implantation.
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NGV