MEDTRONIC, INC. · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Dec 2023
Total Reports
1,542
Reports (30d)
138
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Catheter Array Tangling During Retraction
ablation pulsed, catheter replaced, completed pulsed, issue case, array
164
reports
Vagal Response Causing Sinus Bradycardia
patient complications, outcome, response, presented, result event
40
reports
Pericardial Effusion with Blood Pressure Drop
cardiac ablation, patient complications, event cardiac, pericardial, result event
27
reports
Recurrence of Atrial Fibrillation Post-Ablation
cardiac ablation, patient complications, outcome, mri, result event
8
reports
Hemolysis Following PFA Procedure
lesions, posterior wall, selected, pfa procedure, patients
3
reports
Stroke Occurring During Ablation Procedure
stroke, cardiac ablation, patient complications, magnetic, result event
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Incidence of cough reflex and vagal response among various pulsed field ablation systems: a multicenter registry study.
Kawamura I, et al. · 2025
A single centre experience of pulsed field ablation for atrial fibrillation using the Medtronic PulseSelect System: an analysis of the first 100 patients
Zahid Siddiqui, et al. · Journal of Interventional Cardiac Electrophysiology · 2025
Pulse field ablation in patients with paroxysmal and persistent atrial fibrillation using the circular multielectrode array catheter: first outcome data in a real-world prospective study
Verena Tscholl, et al. · Journal of Interventional Cardiac Electrophysiology · 2026
Initial Real-World Experiences of Pulmonary Vein Isolation and Ablation of Non-Pulmonary Vein Sites Using a Novel Circular Array Pulsed Field Ablation Catheter
Joerg Yogarajah, et al. · Journal of Clinical Medicine · 2024
Direct Comparison of Two Commercially Available Pulsed Field Ablation Systems for Atrial Fibrillation; Procedure Characteristics and Acute Outcomes.
Abeln BGS, 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. 2 active signals detected right now.
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