FDA Medical devices recall ·
Medtronic Sphere-9 Catheter, Model Number AFR-00001 recall
- Recall number
- Z-1948-2026
- Date
- (initiated March 11, 2026)
- Company / brand
- Medtronic, Inc.
8200 Coral Sea St Ne, Mounds View, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 120698 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Why was it recalled?
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 external defibrillation systems are readily available.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
US: Basic UDI Number 0763000B000262284, GTIN: 00763000871741; 00763000973391; 00763000973506; 00763000993269; 00199150003709. OUS: 00763000871734; 00763000973384; 00763000973513; 00763000811341; 00763000911515; 00763000963675; 00199150003716. 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, 0012655016, 0012655017, 0012665669, 0012665670, 0012665671, 0012665673, 0012665674, 0012665675, 0012670372, 0012670375, 0012670377, 0012670380, 0012670381, 0012670383, 0012672152, 0012672156, 0012672157, 0012672158, 0012672159, 0012672160, 0012672161, 0012672162, 0012672163, 0012672164, 0012672166, 0012672167, 0012681148, 0012681149, 0012681151, 0012681152, 0012681153, 0012681154, 0012681155, 0012681157, 0012681159, 0012681160, 0012685946, 0012685947, 001268
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1948-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.