Medtronic Sphere-9 Cardiac Ablation Catheter
Medtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
If you have a Biotronik Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator implanted and are scheduled for cardiac ablation therapy with the Sphere-9 Catheter, contact your physician immediately to discuss the interaction risk and ensure external defibrillation systems are available during the procedure.
Why it was recalled
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.
How to identify it
UPC 00763000871741 00763000973391 00763000973506 00763000871734 00763000973384 00763000973513 00763000811341 00763000911515
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification