Recall MonitorAmplatzer™ Amulet™ Left Atrial Appendage Occluder
· Published by Health Canada · Official notice
Details
Products
| Affected product | Lot or serial number | Model or catalogue number |
|---|---|---|
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-010-028 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-010-031 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-010-034 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-007-020 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-007-022 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-007-016 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-007-018 |
| Amplatzer™ Amulet™ Left Atrial Appendage Occluder | More than 10 numbers, contact manufacturer. | 9-ACP2-010-025 |
Issue
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).