Recall Z-1948-2026 ยท OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Medtronic, Inc.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
| Date | Apr 24, 2026 (initiated Mar 11, 2026) |
| Status | Open, Classified |
| Reason | Ventricular fibrillation (VF) occurred 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 ex |
| Root cause | Device Design |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 3/18/2026 via USPS and email. The notice explained the issue and investigations and provided procedure recommendations: Arrhythmia and or VT/ VF is a known potential adverse event during a cardiac ablation procedure, as indicated within the Sphere-9 IFU. 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. As described in the M |
| Quantity | 120698 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.