QDOT MICRO Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter for Atrial Flutter · First cleared Jul 2026 · 5 device variants grouped
Total Reports
1,297
Reports (30d)
16
Active Signals
4
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Ablation Pericardial Effusion and Tamponade
micro, qdot micro, pericardial, effusion, qdot
24
reports
Irrigation Delivery Issue with Catheter
pebax, qdot micro, patient underwent, qdot, index
12
reports
Inconsistent Irrigation Flow During Ablation
observed, thermocool, ablation procedure, patients, study
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Sep 7, 2022 · Open, Classified
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
Evidence
Related research
Characteristics of tissue temperature during ablation with THERMOCOOL SMARTTOUCH SF versus TactiCath versus QDOT MICRO catheters (Qmode and Qmode+): An in vivo porcine study
Naoto Otsuka, et al. · Journal of Cardiovascular Electrophysiology · 2023
Ablation of Ventricular Tachycardia Using the QDOT MICRO Ablation Catheter ( VT ‐ MICRO Study)
Antonio Di Monaco, et al. · Journal of Arrhythmia · 2026
Technological advances in ventricular tachycardia catheter ablation: the relentless quest for novel solutions to old problems
Paolo Compagnucci, et al. · Journal of Interventional Cardiac Electrophysiology · 2023
Temperature-guided high and very high-power short duration ablation for atrial fibrillation treatment: the peQasus multicentre study
Christian-Hendrik H. Heeger, et al. · EP Europace · 2024
Efficacy and Safety of 60 W Versus 90 W , 4‐s Radiofrequency Applications to the Esophagus‐Adjacent Left Atrial Posterior Wall During Pulmonary Vein Isolation: A Pilot Study
Hideharu Okamatsu, et al. · Journal of Arrhythmia · 2026
Citations indexed from PubMed.
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