Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-02
Summary
The FDA issued a Class II for Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007- by Abbott. Reason: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI)..
Details
Source
Device Recall
External ID
Z-0191-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI 1. 00811806013459 2. 00811806013466 3. 00811806013473 4. 00811806013480 5. 00811806013497 6. 00811806013503 7. 00811806013510 8. 00811806013527 All lots/serial numbers.
Reason for Recall
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-10
Company
Plymouth, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Abbott has 21 FDA actions in our database, including 16 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott have FDA actions?
Abbott has 21 FDA actions in our database, including 16 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0191-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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