PulseSelect Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Dec 2023
Total Reports
2,055
Reports (30d)
121
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Loose Connector Causing Disconnection
procedure catheter, connection, interface, connected, cable
92
reports
Vagal Response Inducing Bradycardia
unknown patient, pacing, vagal response, presented, result event
47
reports
Coronary Spasm with ST Elevation
varipulse, spasm, event cardiac, elevation, result event
8
reports
Acute Pericardial Effusion Post-Procedure
air, pericardial effusion, acute, effusion, result event
3
reports
Guidewire Stuck During Use
selected use, guidewire, farawave, selected, farawave catheter
3
reports
Pericardial Effusion with Blood Pressure Drop
pericardial effusion, farawave, pericardial, effusion, farawave catheter
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Entrapment of the <scp>PulseSelect™</scp> catheter in the pulmonary vein: A rare complication due to soft tissue obstruction
Kohei Iwasa, et al. · Journal of Arrhythmia · 2025
Single-shot ablation for AF: Real-world procedural and one-year outcomes with the newly adopted PulseSelect PFA compared with cryoballoon from the 1STOP project
Giuseppe Boriani, et al. · Journal of Interventional Cardiac Electrophysiology · 2026
PulseSelect vs FARAPULSE pulsed field ablation: Comparative analysis of myocardial, neural-injury and hemolysis biomarkers and short-term outcomes
Christian Gold, et al. · IJC Heart & Vasculature · 2026
Pulmonary vein and posterior wall isolation using the circular, multielectrode catheter for treatment of atrial fibrillation: Acute and long-term outcomes from the Pulsed-Field Ablation for PVI Using PulseSelect With Adjunct Posterior Wall Isolation trial
Ryan K. Manshadi, et al. · Heart Rhythm · 2026
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
Citations indexed from PubMed.
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