HexaGen™ RF Generator AFR-00004Recalls & reported problems
Medtronic, Inc. · GENERATOR AFR-00004 HEXAGEN RF US · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000871864), received between Sep 10, 2025 and Mar 5, 2026 — classified as 2 injuries.
1 other recall cover devices cleared under the same FDA submission (P240013); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A CATHETER TEMPERATURE TOO LOW ERROR OCCURRED. THE CATHETER AND CATHETER CABLE WERE REPLACED, REBOOTING OF THE STACK AND WORKSTATION PERFORMED, AND THE LINK CABLES WERE RECONNECTED, BUT NONE OF THESE TROUBLESHOOTING STEPS RESOLVED THE ERROR. THE CASE WAS ABORTED. TECHNICAL SERVICES RECOMMENDED REPLACEMENT OF THE RADIOFREQUENCY GENERATOR COVERED UNDER WARRANTY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523871 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THAT PULSED FIELD ABLATIONS WERE BEING UTILIZED AROUND THE LEFT PULMONARY VEINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017142 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P240013. One submission often covers many models, so check the product and lot details in each record.
- Z-1948-2026 · Mar 11, 2026 · Open, ClassifiedMedtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Other Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation devices
- FARAWAVE™ M004PF41M401Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall39 deaths1,515 reports
- PulseSelect™ PSCC100Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation3 deaths496 reports
- FARAWAVE™ NAV M004PF41M411Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths417 reports
- VARIPULSE™ Bi-Directional Catheter D141201Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall3 deaths273 reports
- FARAWAVE™ M004PF41M431Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths272 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall15 reports
- FARAWAVE™ M004PF41M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths57 reports
- Volt™ PFA Sensor Enabled™ A-VOLT-01St. Jude Medical, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths38 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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