Reported May 6, 2026 · Ongoing
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial…
Medtronic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic, Inc. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
- Lot codes and dates
- USBasic UDI Number 0763000B000262284
- GTIN
0076300087174100763000973391007630009735060076300099326900199150003709
- OUS
00763000871734007630009733840076300097351300763000811341007630009115150076300096367500199150003716
- Serial Numbers
2,183 of 2,183 codes
22707646923012340002301321000230137300023015430002301547000230155100023015520002301556000230155800023015590002301560000230170900000125737810012576276001257885800125830260012583027001259091300125909140012594540001259454100126092530012609255001260925800126148060012614807001261480800126198930012619896001261989800126198990012623987001262398800126239910012631219001263122000126312210012631222001263527900126352810012635282001263528300126352840012641293001264129400126412950012641297001264339200126433930012643396001264339900126452050012645206001264520800126550050012655006001265500800126550090012655010
- Added on 7/2/2026
63 of 63 codes
001325840100132810360232905928023326512802332651290233265130023326513102332752960233275300023327530200131845270013259314001335039700133503980013350399001335040000133504010013350402001335040300133504040013354397001335439800133543990013354400001335440100133544020013354403001335440400133544050013354406001335616500133561660013356167001335616800133561690013357857001335785800133578590013357861001335786200133583040013363913001336391400133639160013363917001336596000133659610013365962001336596300133659640013365965001336596700133659680013365969001336867400133686760013368679001336868100133686820013368683
- Amount recalled
- 120698 units
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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