MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Flutter, Cardiac Ablation Catheter for Atrial Fibrillation, Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Oct 2024 · 3 device variants grouped
Total Reports
593
Reports (30d)
96
Active Signals
5
Open Recalls
2
What the reports describe · Claripulse analysis
Steam Pop During Radiofrequency Application
anterior, cardiac ablation, sphere catheter, cti, sphere
30
reports
Temperature Fault During Catheter Mapping
cardiac ablation, patient complications, sphere catheter, result event, sphere
30
reports
Heart Block from Atrial Node Ablation
cardiac ablation, patient complications, event cardiac, result event, block
26
reports
Stroke Occurring During Ablation Procedure
stroke, cardiac ablation, patient complications, magnetic, result event
26
reports
Pericardial Effusion with Blood Pressure Drop
cardiac ablation, patient complications, event cardiac, pericardial, result event
19
reports
High Force Reading with Pericardial Effusion
micro, qdot micro, pericardial, effusion, qdot
13
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 11, 2026 · Open, Classified
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
Mar 4, 2019 · Open, Classified
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Evidence
Real‐World Adverse Events Associated With the Sphere‐9 Dual‐Energy Arrhythmia Ablation Catheter
Ahmed Ashraf Morgan, et al. · Journal of Cardiovascular Electrophysiology · 2026
Lattice-shaped catheter ablation for incessant inducible AVNRT in patient undergoing atrial fibrillation ablation: a case report.
Alzubi A, et al. · 2026
A Lattice-Tip Temperature-Controlled Radiofrequency Ablation Catheter for Wide Thermal Lesions
Elad Anter, et al. · JACC. Clinical electrophysiology · 2020
Safety and efficacy of a lattice-tip catheter for ventricular arrhythmia ablation: the AFFERA Ventricular Arrhythmia Ablation Registry (AVAAR).
Sacher F, et al. · 2025
Economic evaluation of a novel dual-energy, large focal lattice-tip catheter versus conventional contact-force sensing radiofrequency catheter, for persistent atrial fibrillation ablation, from the English National Health Service perspective.
Mellor G, et al. · 2026
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. 5 active signals detected right now.
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