United StatesMedtronic Sphere‑9 Catheter (Model AFR‑00001), a percutaneous cardiac ablation catheter for treatment of atrial flutter distributed worldwide, is being recalled. Ventricular fibrillation occurred during radiofrequency therapy in patients with an implanted Biotronik ICD or CRT‑D because of an interaction between the catheter current flow and a safety feature in those devices; Medtronic recommends physicians use increased caution when using the Sphere‑9 in patients with Biotronik ICD/CRT‑D systems and ensure external defibrillation systems are readily available.
What's being recalled
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Recalling firm: Medtronic, Inc., Mounds View, MN, United States.
How to identify it
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, 0012685948, 0012685950, 0012685951, 0012685952, 0012685953, 0012685954, 0012685955, 0012688084, 0012690714, 0012690716, 0012690717, 0012690719, 0012690731, 0012690732, 0012690733, 0012690735, 0012690736, 0012690737, 0012690738, 0012690739, 0012699686, 0012699687, 0012699688, 0012699689, 0012699691, 0012699693, 0012699694, 0012699695, 0012699696, 0012699697, 0012699698, 0012699699, 0012703730, 0012703731, 0012703732, 0012703733, 0012703734, 0012703735, 0012703736, 0012703737, 0012703740, 0012703741…
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)