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RecallWatchMedical Device Safety
Class IIOngoingZ-1948-2026

Medtronic, Inc. recalls Medtronic Sphere-9 Catheter

Medtronic, Inc.Mounds View, MN, United StatesReported May 6, 2026 · 2 months ago
Legal News Analyst ·

Reason for recall

ventricular fibrillation (VF) 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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
0763000B000262284
GTIN
00763000871741; 00763000973391; 00763000973506. OUS: 00763000871734; 00763000973384; 00763000973513; 00763000811341; 00763000911515; 00763000963675
Serial #
227076469, 2301234000, 2301321000, 2301373000, 2301543000, 2301547000 — +2177 moreShow all
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0012886870, 0012886871, 0 …

What the firm is doing

Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 3/18/2026 via USPS and email. The notice explained the issue, the details of the investigations and provided the following procedure recommendations: Arrhythmia and or VT/ VF is a known potential adverse event during a cardiac ablation procedure, as indicated within the Sphere-9 IFU. 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. As described in the Medtronic Sphere-9 IFU, defibrillation equipment must be available for immediate use in the case of a life-threatening arrhythmia. Further, the IFU recommends to not deliver energy when in contact with pacing and defibrillation leads. CUSTOMER ACTIONS: Follow the procedure recommendations listed in this letter in addition to the Instructions for Use (IFU) when using a Sphere-9 catheter with a concomitant Biotronik ICD/CRT-D. Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession. Please forward this notice to all those who need to be aware within your organization, including, but not limited to, physicians using the Sphere-9 catheter, and maintain a copy for your records.

DistributionShow details

Worldwide

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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