MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Dec 2010
Total Reports
550
Reports (30d)
7
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
High Force Reading with Pericardial Effusion
micro, qdot micro, pericardial, effusion, qdot
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 4, 2019 · Open, Classified
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Evidence
Comparative efficacy and safety of POLARx versus Arctic front advance pro cryoballoon systems for pulmonary vein isolation in atrial fibrillation: an updated systematic review and meta-analysis.
Tahir MF, et al. · 2025
Ablation of Atrial Fibrillation Using the fourth-generation Cryoballoon Arctic Front Advance PRO
Erik Wißner · Future Cardiology · 2020
Cryoballoon Ablation With the POLARx FIT or the Arctic Front Advance Pro for Paroxysmal Atrial Fibrillation: A Health Economic Analysis.
Pannone L, et al. · 2025
Colchicine in addition to usual care for acute pericarditis with classical ECG changes after catheter ablation for cardiac arrhythmias.
Toniolo M, et al. · 2026
Evaluation of the novel multi-points surface thermometry cryoballoon in the treatment of paroxysmal atrial fibrillation.
Bai L, et al. · 2025
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. 1 active signal detected right now.
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