CanadaAmplatzer Amulet Left Atrial Appendage Occluder, sold by Abbott Medical, is affected; model/catalogue numbers include 9-ACP2-010-028, -031, -034, -025 and 9-ACP2-007-020, -022, -016, -018. Abbott is updating the instructions for use to specifically identify the pulmonary artery as an adjacent structure and to add guidance on assessing the distance between the device landing zone and the pulmonary artery because of concerns about pulmonary artery injury; the notice says the issue is not associated with defectiveness. Contact the manufacturer for additional information.
What's being recalled
Companies: Abbott Medical, 5050 Nathan Lane North, Plymouth, Minnesota, United States, 55442.
How to identify it
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-010-028
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-010-031
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-010-034
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-007-020
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-007-022
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-007-016
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-007-018
Affected product: Amplatzer™ Amulet™ Left Atrial Appendage Occluder; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 9-ACP2-010-025
The 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).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States