Sphere-9 Catheter Adverse Events: FDA MAUDE Data
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
1,011
Reports (30d)
108
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
High Temperature Sensor Error
ventricular, sphere catheter, error, result event, sphere
56
reports
Impedance Increase During RF Application
cavotricuspid isthmus, sphere catheter, outcome case, intracardiac echocardiography, radiofrequency
14
reports
Asymptomatic Cerebral Infarction Detected
day, cerebral, infarction, imaging, result event
13
reports
Substance on Catheter Handle
substance, procedure catheter, tip, resistance, outcome case
12
reports
Ventricular Tachycardia Induced by Ablation
cavotricuspid isthmus, ventricular, cavotricuspid, radiofrequency, result event
10
reports
Coronary Spasm with ST Elevation
varipulse, spasm, event cardiac, elevation, result event
10
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
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
Related research
Real‐World Adverse Events Associated With the Sphere‐9 Dual‐Energy Arrhythmia Ablation Catheter
Ahmed Ashraf Morgan, et al. · Journal of Cardiovascular Electrophysiology · 2026
First 1000 Cases of Dual-Energy Lattice-Tip Ablation for Atrial Fibrillation: Procedural Experience, Clinical Practice Impact, And Cost Analysis.
Na J, et al. · Heart rhythm · 2026
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
Greg Mellor, et al. · Open Heart · 2026
Lattice-shaped catheter ablation for incessant inducible AVNRT in patient undergoing atrial fibrillation ablation: a case report.
Alzubi A, et al. · European heart journal. Case reports · 2026
Feasibility and safety of ablation using a dual-energy, lattice-tip, map-and-ablate catheter in patients with mechanical heart valves.
Keller J, et al. · Heart rhythm · 2026
Citations indexed from PubMed.
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