ABBOTT (ST. JUDE MEDICAL) · Left Atrial Appendage Closure · First cleared Apr 2025 · 8 device variants grouped
Total Reports
2,407
Reports (30d)
49
Active Signals
9
Open Recalls
0
What the reports describe · Claripulse analysis
Pericardial Effusion Post-Implant
amplatzer amulet, amulet, pericardial, effusion, amplatzer
102
reports
Literature Batch: Peri-Device Leak Analysis
data, terms, article, occurred, event terms
8
reports
Thrombus Detected on Follow-Up Imaging
tee, performed watchman, thrombosis, closure procedure, thrombus
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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
First Experience With Amulet in the United States
Mohamad Alkhouli, et al. · JACC: Cardiovascular Interventions · 2024
Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device
Kasper Korsholm, et al. · Journal of Interventional Cardiac Electrophysiology · 2022
Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study
Adel Aminian, et al. · EuroIntervention · 2021
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 9 active signals detected right now.
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