Real-World Adverse Events Associated With the Sphere-9 Dual-Energy Arrhythmia Ablation Catheter
Ahmed Ashraf Morgan1, Suraj Adhikari1, Adir Alper1
1Department of Medicine, Jacobi Medical Center, Albert Einstein College of Medicine, New York, New York, USA.
Journal of Cardiovascular Electrophysiology
|May 15, 2026
Summary
This study analyzed Sphere-9 catheter adverse events, finding arrhythmias like VT/VF and AV block, alongside risks from ICD-catheter interactions. Further assessment is crucial for patient safety.
Area of Science:
- Cardiology
- Medical Device Safety
- Electrophysiology
Background:
- The Sphere-9 catheter, approved for atrial fibrillation, delivers pulsed field and radiofrequency ablation.
- Adverse events associated with the Sphere-9 catheter necessitate a systematic review to understand complications.
Purpose of the Study:
- To systematically assess adverse events reported for the Sphere-9 catheter.
- To identify and categorize complications related to Sphere-9 catheter use.
Main Methods:
- A query of the FDA MAUDE database was conducted from October 24, 2024, to October 24, 2025.
- A total of 222 reports concerning the Sphere-9 catheter were included in the analysis.
Main Results:
- Of 222 reports, 148 (67%) involved clinical events, with 107 suspected to be Sphere-9 related.
- Key complications included VT/VF (30), Stroke/TIA (25), sinus node dysfunction/AV block (23), and ICD-catheter interactions (10).
- Non-clinical event reports included tissue/char formation (24) and steam pops (25).
Conclusions:
- Early analysis reveals Sphere-9 catheter complications such as VT/VF, AV block, and risks from ICD-catheter interactions.
- This highlights the need for ongoing monitoring and risk mitigation strategies for this device.
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