Amplatzer Amulet Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Left Atrial Appendage Closure · First cleared Apr 2025 · 8 device variants grouped
Total Reports
2,651
Reports (30d)
45
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Proximal Device Deployment Issue
amulet left, amplatzer amulet, amulet, occluder, amplatzer
87
reports
Literature Batch: LAAO Safety Comparison
average age, corresponding, research, included study, average
16
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial
Dhanunjaya Lakkireddy, et al. · Journal of the American College of Cardiology · 2024
Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study
Philipp Jakob, et al. · Structural Heart · 2025
Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)
Lucie Kretzler, et al. · BMC Cardiovascular Disorders · 2022
3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE)
Dhanunjaya Lakkireddy, et al. · JACC: Cardiovascular Interventions · 2023
Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial
Dhanunjaya Lakkireddy, et al. · Circulation · 2021
Citations indexed from PubMed.
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