Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, car...
Reason for Recall / Hazard
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.
Product Description & Identification
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Additional Source Details
| Field | Value |
|---|---|
| City | Mounds View |
| State | MN |
| Event id | 98653 |
| Address 1 | 8200 Coral Sea St Ne |
| Code info | 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, 2301709000, 0012573781, 0012576276, 0012578858, 0012583026, 0012583027, 0012590913, 0012590914, 0012594540, 0012594541, 0012609253, 0012609255, 0012609258, 0012614806, 0012614807, 0012614808, 0012619893, 0012619896, 0012619898, 0012619899, 0012623987, 0012623988, 0012623991, 0012631219, 0012631220, 0012631221, 0012631222, 0012635279, 0012635281, 0012635282, 0012635283, 0012635284, 0012641293, 0012641294, 0012641295, 0012641297, 0012643392, 0012643393, 0012643396, 0012643399, 0012645205, 0012645206, 0012645208, 0012655005, 0012655006, 0012655008, 0012655009, 0012655010, 0012655011, 0012655012, 0012655013, 0012655014, 0012655015, 00... [TRUNCATED] |
| Postal code | 55112-4391 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 77510 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260424 |
Overview
- Recalling FirmMedtronic, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide