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
1,074
Reports (30d)
61
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Temperature Sensor Error
ventricular, rhythm, sphere catheter, radiofrequency, sphere
40
reports
Cerebral Infarction Post-Ablation
stroke, cerebral, cerebral infarction, completed cardiac, imaging
20
reports
Steam Pop During Cavotricuspid Ablation
cavotricuspid isthmus, isthmus, temperature, cavotricuspid, radiofrequency
18
reports
Substance on Catheter Handle
resistance, handle, resolved issue, white, substance
15
reports
Temperature Sensor Fault During Procedure
event cardiac, temperature, error, resolved issue, completed cardiac
15
reports
Vagal Response Inducing Heart Block
heart block, vagal response, procedure vagal, response observed, complete heart
12
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
Jonathan Na, et al. · Heart Rhythm · 2026
Feasibility and safety of ablation using a dual-energy, lattice-tip, map-and-ablate catheter in patients with mechanical heart valves
Jonas Keller, et al. · Heart Rhythm · 2026
A Focal Ablation Catheter Toggling Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation
Vivek Yerrapu Reddy, et al. · JACC. Clinical electrophysiology · 2023
Lattice-shaped catheter ablation for incessant inducible AVNRT in patient undergoing atrial fibrillation ablation: a case report
Alhasan Saleh Alzubi, et al. · European Heart Journal - Case Reports · 2026
Citations indexed from PubMed.
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