ClosureRFG RFG2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521140394), received between Apr 20, 2017 and Feb 7, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Device Displays Incorrect Message; Power Problem; Device Displays Incorrect Message; Power Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE RFG2 RADIOFREQUENCY GENERATOR, AN ERROR CODE 477 WAS DISPLAYED, CAUSING A ROUGHLY 10-MINUTE DELAY WHILE TURNING ON/OFF (POWER-CYCLED) THE GENERATOR MULTIPLE TIMES TO ATTEMPT TO CLEAR THE CODE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS INITIALLY INTENDED TO PERFORM AN ABLATION ON THE GREAT SAPHENOUS VEIN (GSV) ON THE RIGHT SIDE AT A PROXIMAL LOCATION. THE DEVICE WAS NOT USED IN THE PATIENT, AND NO SEGMENTS WERE TREATED AS THE GENERATOR DID NOT FUNCTION DUE TO THE GENERATOR ISSUE, THE TREATMENT PLAN WAS ALTERED, AND THE PROCEDURE WAS SWITCHED TO STRIPPING/PHLEBECTOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21332113 ↗
• InjuryFeb 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A RADIOFREQUENCY GENERATOR WAS INTENDED TO BE USED. IT WAS REPORTED THE RADIOFREQUENCY GENERATOR DOES NOT RECOGNISE THE CLOSUREFAST CATHETER. ANOTHER CLOSUREFAST CATHETER WAS ATTEMPTED TO BE USED WITH THE GENERATOR. THE PATIENT HAD TO UNDERGO OPEN SURGERY FOR SAPHENECTOMY, INSTEAD OF BEING ABLE TO UNDERGO RADIOFREQUENCY THERMAL ABLATION.

  Patient problems: Insufficient Information

  MAUDE report 16389511 ↗
• InjuryMar 12, 2020Output Problem; Output Problem

  PHYSICIAN WAS ATTEMPTING TO USE RFG2 DURING PROCEDURE. IT WAS REPORTED THAT AFTER INSERTING THE CATHETER, WHEN TRYING TO START ABLATION, THE DEVICE DID NOT WORK. ERROR MESSAGE WAS NOT CHECKED AT THAT TIME, BUT WHEN IT WAS CHECKED AT THE TIME OF COLLECTION, ERROR MESSAGE ¿TREATMENT HALTED: NON-UNIFORM TEMPERATURE¿ WAS DISPLAYED. A DIFFERENT CATHETER WAS OPENED AND TREATMENT WAS ATTEMPTED, BUT THE DEVICE COULD NOT BE USED DUE TO THE SAME ERROR, SO TREATMENT WITH HIGH FREQUENCY WAS GIVEN UP. AFTER THAT, TREATMENT WAS COMPLETED BY HIGH LIGATION PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 9822666 ↗
• MalfunctionOct 13, 2017Unintended Power Up; Device Operates Differently Than Expected; Unintended Power Up; Device Operates Differently Than Expected

  IT WAS REPORTED THAT RFG2 GENERATOR FIRED ON ITS OWN WITHOUT BEING TURNED ON BY THE HAND SWITCH, WHEN CONNECTED TO A DISPOSABLE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6948912 ↗
• MalfunctionApr 20, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED A RFG2 GENERATOR FOR REPAIR. IT WAS ALLEGED THAT SMOKE WAS OBSERVED AT THE BACK OF THE DEVICE AND THE DEVICE WAS IMMEDIATELY REMOVED. IT IS REPORTED THAT THE POWER SUPPLY RF CONTROLLER PCA WAS DAMAGED AND MUST BE CHANGED. THE DEVICE WAS CLEANED AND DISINFECTED. THERE WAS NO PATIENT HARM REPORTED FOR THIS EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6507811 ↗