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
780
Reports (30d)
98
Active Signals
5
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Steam Pop with Sphere Catheter
cardiac ablation, temperature, sphere catheter, radiofrequency, sphere
47
reports
Ventricular Tachycardia Induced During Ablation
ventricular, cardiac ablation, event cardiac, result event, radiofrequency
31
reports
Stroke Following High Temperature Error
stroke, cardiac ablation, acute, magnetic, result event
25
reports
Pericardial Effusion with Blood Pressure Drop
blood pressure, pericardial effusion, cardiac ablation, pericardial, result event
23
reports
Temperature Sensor Failure During Mapping
catheter replaced, cardiac ablation, temperature, error, cable
17
reports
Temperature Control Error on Catheter
sphere
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.
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