Recall Z-1948-2026— Medtronic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic, Inc., initiated 2026-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.. Reason: 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..
- Recalling firm
- Medtronic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-11
- Firm location
- Mounds View, MN, United States
Product description
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.