Class II U.S. Food and Drug Administration

Medtronic Sphere-9 Catheter recall: Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy

Recall published 6 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1948-2026
Published
May 6, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic, Inc.
Product type
Medical devices
Units affected
120698 units
Made in
United States
Lot / code info
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, 0012703743, 0012703744, 0012705502, 0012705503, 0012705504, 0012705505, 0012705506, 0012705507, 0012705508, 0012705509, 0012705510, 0012705512, 0012716663, 0012716664, 0012716665, 0012716666, 0012716667, 0012716668, 0012716669, 0012716670, 0012716671, 0012716672, 0012716673, 0012716674, 0012724581, 0012724583, 0012724605, 0012724606, 0012724607, 0012724608, 0012724609, 0012724610, 0012724612, 0012724613, 0012728680, 0012728681, 0012728682, 0012728684, 0012728686, 0012728688, 0012728689, 0012740819, 0012740820, 0012740821, 0012740823, 0012740824, 0012740825, 0012740855, 0012740856, 0012740857, 0012740858, 0012743381, 0012743382, 0012743384, 0012743385, 0012743386, 0012743387, 0012743388, 0012743389, 0012743390, 0012743393, 0012743495, 0012743496, 0012752332, 0012752333, 0012752334, 0012752335, 0012752336, 0012752337, 0012752338, 0012752340, 0012752341, 0012754564, 0012754565, 0012754566, 0012754567, 0012754568, 0012754569, 0012754570, 0012754571, 0012758280, 0012758281, 0012758282, 0012758285, 0012758286, 0012758287, 0012758288, 0012758289, 0012760403, 0012760404, 0012760405, 0012760406, 0012760407, 0012760408, 0012760409, 0012760411, 0012762277, 0012762278, 0012762279, 0012762280, 0012762281, 0012762282, 0012762283, 0012762284, 0012765019, 0012765020, 0012777959, 0012777961, 0012777962, 0012777964, 0012777965, 0012777985, 0012777986, 0012777987, 0012777989, 0012777991, 0012781703, 0012783280, 0012783281, 0012783282, 0012783283, 0012783284, 0012783285, 0012783286, 0012783288, 0012783293, 0012783298, 0012784425, 0012784426, 0012784427, 0012784428, 0012784429, 0012784430, 0012784431, 0012784432, 0012784433, 0012784434, 0012794827, 0012794828, 0012794829, 0012794831, 0012794832, 0012794833, 0012794835, 0012794836, 0012794837, 0012794839, 0012794840, 0012794849, 0012794850, 0012794851, 0012794854, 0012794855, 0012794856, 0012794857, 0012794858, 0012794860, 0012794861, 0012794863, 0012794864, 0012794865, 0012794866, 0012794867, 0012794868, 0012794869, 0012794870, 001279487…
UPC codes
00763000871741, 00763000973391, 00763000973506, 00763000993269, 00763000871734, 00763000973384, 00763000973513, 00763000811341, 00763000911515, 00763000963675

Products covered by this recall

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

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000871741
  • 00763000973391
  • 00763000973506
  • 00763000993269
  • 00763000871734
  • 00763000973384
  • 00763000973513
  • 00763000811341
  • 00763000911515
  • 00763000963675

Model or item number

On the rating label, the box or the instruction sheet.

  • AFR-00001

Serial number

On the rating plate, often next to the date of manufacture.

  • 227076469
  • 2301234000
  • 2301321000
  • 230137

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medtronic, Inc. — 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic, Inc. medical devices 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000871741, 00763000973391, 00763000973506; model number AFR-00001. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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