Abbott Recalls Amplatzer Amulet Left Atrial Appendage Occluder Devices
Abbott is recalling Amplatzer Amulet Left Atrial Appendage Occluder devices to update instructions for use regarding the risk of pulmonary artery injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is an FDA Class II recall involving changes to the Instructions for Use regarding the risk of Pulmonary Artery Injury. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Abbott is recalling the Amplatzer Amulet Left Atrial Appendage Occluder, including eight specific model numbers. The recall is being conducted to make changes to the Instructions for Use (IFU) for the device. The updated instructions address the risk of Pulmonary Artery Injury (PAI).
The affected devices were distributed worldwide and nationwide in the United States. The recall covers all lots and serial numbers for the listed model numbers.
Consumers and healthcare providers should refer to the updated Instructions for Use for information regarding the risk of Pulmonary Artery Injury.
The recalled product
- 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
- Manufacturer
- Abbott
- Category
- Medical Device — Cardiovascular
Distribution
Distributed nationwide across the United States.
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