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.
Recall at a glance
- Quantity recalled
- 77510 units
Why it was recalled
Medtronic is recalling the Sphere-9 Catheter (Model AFR-00001), a percutaneous cardiac ablation catheter for treating atrial flutter, due to risk of ventricular fibrillation during radiofrequency therapy in patients with Biotronik Implantable Cardioverter Defibrillators (ICDs) or Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds). The hazard results from an interaction between the catheter's current flow and Biotronik device safety features. Physicians should use increased caution when performing RF ablation with this catheter in patients with Biotronik ICD/CRT-D systems and ensure external defibrillation equipment is immediately available.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
- UDI-DI
- 00763000871741, 00763000973391, 00763000973506, 00763000993269, 00199150003709, 00763000871734, 00763000973384, 00763000973513, 00763000811341, 00763000911515, 00763000963675, 00199150003716, 227076469, 2301234000, 2301321000, 2301373000, 2301543000, 2301547000, 2301551000, 2301552000
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification