Medtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
Medtronic Sphere-9 Catheters used for cardiac ablation may trigger ventricular fibrillation during radiofrequency therapy in patients with Biotronik implantable defibrillators due to an interaction between catheter current flow and a device safety feature.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source describes a risk-of-harm condition (ventricular fibrillation, a serious cardiac event) where the hazard is known but no reported illnesses or injuries are documented. This fits the rubric criterion for High severity: "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Medtronic is cautioning physicians about a potential risk with the Sphere-9 Catheter (Model AFR-00001), used for percutaneous cardiac ablation treatment of atrial flutter. The catheter's radiofrequency energy can interact with a safety feature built into Biotronik Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds), potentially causing ventricular fibrillation in affected patients.
This interaction is caused by how the Sphere-9 catheter delivers radiofrequency current during ablation therapy. Patients with Biotronik ICD or CRT-D systems are at risk if the Sphere-9 catheter is used for their treatment.
Medtronic recommends that physicians use increased caution when performing radiofrequency ablation with the Sphere-9 catheter in patients with Biotronik ICD/CRT-D systems. Physicians should ensure external defibrillation systems are readily available during the procedure. Approximately 77,510 units of the Sphere-9 catheter have been distributed worldwide.
The recalled product
- Product
- Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
- Manufacturer
- Medtronic, Inc.
- Hazard
- ventricular-fibrillation
- device-interaction
- radiofrequency-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- US: Basic UDI Number 0763000B000262284
- GTIN: 00763000871741
- 00763000973391
- 00763000973506. OUS: 00763000871734
- 00763000973384
- 00763000973513
- 00763000811341
- 00763000911515
- 00763000963675. Serial Numbers: 227076469
- 2301234000
- 2301321000
- 2301373000
- 2301543000
- 2301547000
- 2301551000
- 2301552000
- 2301556000
- 2301558000
- 2301559000
- 2301560000
Distribution
Distribution scope not specified by the agency.
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