Medtronic, Inc. recalls Medtronic Sphere-9 Catheter

Recalling company

Medtronic, Inc.

Product

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

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 external defibrillation systems are readily available.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 11, 2026

Reported

May 6, 2026

Distribution

Worldwide

Status

Ongoing

Quantity

120698 units

Lot / codes

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, 00126859

Company location

Mounds View, MN

Recall type

Voluntary: Firm initiated

Recall number

Z-1948-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1948-2026 in the FDA Enforcement Report. Also see FDA recall press releases.