OFFICIAL-SOURCE RECALL · CANADA
Amplatzer™ Amulet™ Left Atrial Appendage Occluder Recall: The current Amulet™ IFU contains a
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
The current Amulet™ IFU contains a contraindication against use "where placement of the device would interfere with any intracardiac or intravascular structures." Abbott is updating this contraindication to specifically identify the pulmonary artery as one of the adjacent structures. In addition, Abbott is updating the IFU to include additional guidance about assessing the distance between the device landing zone and the pulmonary artery. Abbott recently completed additional physician training on this subject. For clarification, this recall is not associated with defectiveness or possible defectiveness. Abbott is informing consignees about changes to the instructions for use (IFU) for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder (referred to as Amulet™) regarding pulmonary artery injury (PAI).
Hazard
The current Amulet™ IFU contains a contraindication against use "where placement of the device would interfere with any intracardiac or intravascular structures." Abbott is updating this contraindication to specifically identify the pulmonary artery as one of the adjacent structures. In addition, Abbott is updating the IFU to include additional guidance about assessing the distance between the device landing zone and the pulmonary artery. Abbott recently completed additional physician training on this subject. For clarification, this recall is not associated with defectiveness or possible defectiveness. Abbott is informing consignees about changes to the instructions for use (IFU) for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder (referred to as Amulet™) regarding pulmonary artery injury (PAI).
Official recall notice
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Agency: Health Canada
Official publication date: September 25, 2026
Read the official CANADA_HEALTH recall notice →SCAN ONCE. KEEP WATCHING.
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