ABBOTT (ST. JUDE MEDICAL) · Transcatheter Septal Occluder (ASD/PFO) · First cleared Dec 2017
Total Reports
190
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Device Deformation During Preparation
pfo, talisman, amplatzer talisman, pfo occluder, talisman pfo
7
reports
Literature Batch: PFO Closure Long-Term Outcomes
pfo closure, pfo, included study, patients, included
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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