Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Recall
- Recall Number
- Z-1948-2026
- Event Number
- 98653
- Firm
- Medtronic, Inc.
- FEI Number
- 2182208
- Product Code
- OAD
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- March 11, 2026
- Posted
- April 24, 2026
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
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.
Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 3/18/2026 via USPS and email. The notice explained the issue, the details of the investigations and provided the following 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 Medtronic Sphere-9 IFU, defibrillation equipment must be available for immediate use in the case of a life-threatening arrhythmia. Further, the IFU recommends to not deliver energy when in contact with pacing and defibrillation leads. CUSTOMER ACTIONS: Follow the procedure recommendations listed in this letter in addition to the Instructions for Use (IFU) when using a Sphere-9 catheter with a concomitant Biotronik ICD/CRT-D. Complete the enclosed Customer Confirmation Form and email to [email protected]. This form must be returned even if you do not have any affected product in your possession. Please forward this notice to all those who need to be aware within your organization, including, but not limited to, physicians using the Sphere-9 catheter, and maintain a copy for your records.
Worldwide
77510 units