FDA recall, , Moderate risk
Abbott Amplatzer Amulet Left Atrial Appendage Occluder
The Amplatzer Amulet Left Atrial Appendage Occluder has changes to its instructions regarding risk of pulmonary artery injury.
Summary by Recall Canary from the FDA notice
What happened
Abbott is recalling the Amplatzer Amulet Left Atrial Appendage Occluder due to changes to the Instructions for Use (IFU) regarding the risk of Pulmonary Artery Injury (PAI). The recall began September 10, 2026, and was added to the FDA's Enforcement Report on October 16, 2026. Distribution is nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Amplatzer Amulet Left Atrial Appendage Occluder
- Model number
- 9-ACP2-007-016
- 9-ACP2-007-018
- 9-ACP2-007-020
- 9-ACP2-007-022
- 9-ACP2-010-025
- 9-ACP2-010-028
- 9-ACP2-010-031
- 9-ACP2-010-034
- UDI-DI
- 00811806013459
- 00811806013466
- 00811806013473
- 00811806013480
- 00811806013497
- 00811806013503
- 00811806013510
- 00811806013527
- Lot code
- All lots/serial numbers.
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- Abbott
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99844
- Recall number
- Z-0191-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
