Z-0191-2027 Class II Ongoing
FDA device recall Z-0191-2027 was initiated by Abbott on Sep 10, 2026 and is designated Class II. Reason for recall: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 28, 2026
- Initiation Date
- Sep 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
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).
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0191-2027
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026