Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Recall Summary The Amplatzer Amulet Left Atrial Appendage Occluder is being recalled in Canada due to a labelling or packaging defect. This device is used to block the left atrial appendage of the heart in certain patients. The recall affects all units distributed across Canada and is classified as a Class II recall.
- Product
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Reason
- Labelling or packaging defect
- Classification
- Class II
- Category
- medical device recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2026-09-25
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b8366469-20ca-4501-8242-f2cf4f4060a3