MEDTRONIC, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Nov 2016
Total Reports
336
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Mapping Catheter Kinking During Cryo Ablation
cryo, issue case, case completed, balloon, completed cryo
2
reports
Pericardial Effusion Post-Ablation
right, pericardial effusion, pericardial, effusion, pericardiocentesis
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Citations indexed from PubMed.
Keep exploring
ACHIEVE
MEDTRONIC, INC. · 1,206 reports
PENTARAY NAV
Biosense Webster Inc · 549 reports
IntellaMap Orion
BOSTON SCIENTIFIC CORPORATION · 418 reports
Advisor HD Grid, Sensor Enabled
ABBOTT (ST. JUDE MEDICAL) · 408 reports
OCTARAY Mapping Catheter
Biosense Webster Inc · 151 reports
DECANAV
Biosense Webster Inc · 122 reports
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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