ClosureRFG RFG3 (UDI 10884521196544)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521196544), received between Jul 11, 2017 and Apr 14, 2026 — classified as 19 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Overheating of Device

  IT WAS REPORTED THAT A RADIOFREQUENCY GENERATOR 3 IS OVERHEATING AND REQUIRES A REBOOT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE ISSUE OCCURRED DURING A VERIFICATION FROM THE BIOMEDICAL, NOT DURING THE PROCEDURE. IT WAS REPLACED WITH A NEW GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873186 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD GREAT SAPHENOUS VEIN (GSV) TREATED USING A CLOSUREFAST DEVICE AND RFG3 RADIOFREQUENCY GENERATOR. TUMESCENT INFILTRATION WAS USED. LOCAL ANESTHESIA WAS USED AND COMPRESSION WAS APPLIED BY HAND. THE PROCEDURE IS REPORTED TO HAVE BEEN COMPLETED WITHOUT ANY ISSUE. THE VEIN IS REPORTED TO HAVE CLOSED. 72 HOURS POST PROCEDURE, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) FOR STAT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH SHOWED POSITIVE PULMONARY EMBOLISM (PE. THE PATIENT WAS STARTED ON ELIQUIS. ONE WEEK POST PROCEDURE, ULTRASOUND REVEALED CLASS I ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT). AT THIS TIME THE PHYSICIAN DOES NOT SUSPECT THE CLOSUREFAST CATHETER TO BE A CONTRIBUTORY CAUSE. NO FURTHER INJURY REPORTED.

  Patient problems: Pulmonary Embolism; Thrombosis

  MAUDE report 10161831 ↗
• MalfunctionOct 15, 2019Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT IS REPORTED THAT DURING USE OF THIS RFG3 FOR TREATMENT OF THE PATIENT'S GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV), 14 WATTS IS NOT ACHIEVED IN THE TIME IT SHOULD BE. THIS ISSUE DOES NOT OCCUR WHEN USING A DIFFERENT RFG3. THIS IS REPORTED TO HAVE RESULTED IN THE PATIENT GETTING VERY ABLATED AND A HIGHER EHIT RATE. PATIENT HAS EHIT 1-3 AND ACETYLSALICYLIC ACID (ASA) IS PRESCRIBED FOR THE 1S AND LOVENOX FOR 1 WEEK FOR II-III. IF THIS IS NOT RESOLVED IN A WEEK THEN WARFARIN OR OTHER NEWER AGENT FOR 3 MONTHS WILL BE PRESCRIBED.

  Patient problems: Thrombus

  MAUDE report 9189760 ↗
• MalfunctionOct 15, 2019Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT IS REPORTED THAT DURING USE OF THIS RFG3 FOR TREATMENT OF THE PATIENT'S GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV), 14 WATTS IS NOT ACHIEVED IN THE TIME IT SHOULD BE. THIS ISSUE DOES NOT OCCUR WHEN USING A DIFFERENT RFG3. THIS IS REPORTED TO HAVE RESULTED IN THE PATIENT GETTING VERY ABLATED AND A HIGHER EHIT RATE. PATIENT HAS EHIT 1-3 AND ACETYLSALICYLIC ACID (ASA) IS PRESCRIBED FOR THE 1S AND LOVENOX FOR 1 WEEK FOR II-III. IF THIS IS NOT RESOLVED IN A WEEK THEN WARFARIN OR OTHER NEWER AGENT FOR 3 MONTHS WILL BE PRESCRIBED.

  Patient problems: Thrombus

  MAUDE report 9189756 ↗
• MalfunctionOct 15, 2019Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT IS REPORTED THAT DURING USE OF THIS RFG3 FOR TREATMENT OF THE PATIENT'S GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV), 14 WATTS IS NOT ACHIEVED IN THE TIME IT SHOULD BE. THIS ISSUE DOES NOT OCCUR WHEN USING A DIFFERENT RFG3. THIS IS REPORTED TO HAVE RESULTED IN THE PATIENT GETTING VERY ABLATED AND A HIGHER EHIT RATE. PATIENT HAS EHIT 1-3 AND ACETYLSALICYLIC ACID (ASA) IS PRESCRIBED FOR THE 1S AND LOVENOX FOR 1 WEEK FOR II-III. IF THIS IS NOT RESOLVED IN A WEEK THEN WARFARIN OR OTHER NEWER AGENT FOR 3 MONTHS WILL BE PRESCRIBED.

  Patient problems: Thrombus

  MAUDE report 9189755 ↗
• MalfunctionOct 15, 2019Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT IS REPORTED THAT DURING USE OF THIS RFG3 FOR TREATMENT OF THE PATIENT'S GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV), 14 WATTS IS NOT ACHIEVED IN THE TIME IT SHOULD BE. THIS ISSUE DOES NOT OCCUR WHEN USING A DIFFERENT RFG3. THIS IS REPORTED TO HAVE RESULTED IN THE PATIENT GETTING VERY ABLATED AND A HIGHER EHIT RATE. PATIENT HAS EHIT 1-3 AND ACETYLSALICYLIC ACID (ASA) IS PRESCRIBED FOR THE 1S AND LOVENOX FOR 1 WEEK FOR II-III. IF THIS IS NOT RESOLVED IN A WEEK THEN WARFARIN OR OTHER NEWER AGENT FOR 3 MONTHS WILL BE PRESCRIBED.

  Patient problems: Thrombus

  MAUDE report 9189754 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A PATIENT WAS TREATED WITH A CLOSUREFAST CATHETER AND AN RFG3 GENERATOR. THE PATIENT HAS SHOWN INFLAMMATORY RESPONSE AND ULCER IN ALL ABLATION TREATED AREAS.

  Patient problems: Inflammation; Ulcer

  MAUDE report 7494493 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A PATIENT WAS TREATED WITH A CLOSUREFAST CATHETER AND AN RFG3 GENERATOR. THE PATIENT HAS SHOWN INFLAMMATORY RESPONSE AND ULCER IN ALL ABLATION TREATED AREAS.

  Patient problems: Inflammation; Ulcer

  MAUDE report 7494479 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A PATIENT WAS TREATED WITH A CLOSUREFAST CATHETER AND RFG GENERATOR. THE PATIENT HAS SHOWN INFLAMMATORY RESPONSE IN ALL ABLATION TREATED AREA AND ULCERS.

  Patient problems: Inflammation; Ulcer

  MAUDE report 7494461 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A PATIENT WAS TREATED WITH A CLOSUREFAST CATHETER AND AN RFG3 GENERATOR. THE PATIENT HAS SHOWN INFLAMMATORY RESPONSE AND ULCER IN ALL ABLATION TREATED AREAS.

  Patient problems: Inflammation; Ulcer

  MAUDE report 7494448 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A PATIENT WAS TREATED WITH A CLOSUREFAST CATHETER AND AN RFG3 GENERATOR. THE PATIENT HAS SHOWN INFLAMMATORY RESPONSE AND ULCER IN ALL ABLATION TREATED AREAS.

  Patient problems: Inflammation; Ulcer

  MAUDE report 7494412 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 4CM FROM THE SFJ. THE DIAMETER PRE RFA 13MM PROX THIGH, 6.8MM MID-THIGH. A TOTAL OF 42CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS 'LOOSELY ATTACHED IN GSV NOT EXTENDING'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285922 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 3.5CM FROM THE SFJ. THE DIAMETER PRE RFA 12MM SFJ, 12MM PROX THIGH, 9.3MM MID-THIGH. A TOTAL OF 49CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS A 'TRAILING THROMBUS'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285891 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 3CM FROM THE SFJ. THE DIAMETER PRE RFA 8.8MM SFJ, 11.4 PROX THIGH, 7.8 MM MID-THIGH. A TOTAL OF 30CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS A 'TRAILING THROMBUS'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285857 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 2.6 CM FROM THE SFJ. THE DIAMETER PRE RFA 12.7 SFJ, 12 PROX THIGH, 4.7 MM MID-THIGH (ANT-GSV). A TOTAL OF 15 CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS A 'TRAILING THROMBUS'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285840 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF RIGHT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 3CM FROM THE SFJ. THE DIAMETER PRE RFA 11 MM SFJ, 9.7MM PROX THIGH, 7.4 MM MID-THIGH. A TOTAL OF 42CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS A 'TRAILING THROMBUS'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285718 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 2.4CM FROM THE SFJ. THE DIAMETER PRE RFA 7.3MM SFJ, 7.3MM PROX THIGH, 6.4 MM MID-THIGH. A TOTAL OF 33CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS 'LOOSELY ATTACHED IN GSV NOT EXTENDING'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285703 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 2.3 CM FROM THE SFJ. THE DIAMETER PRE RFA 11 MM, 7.6 MM PROX THIGH, 5.5 MM MID-THIGH. A TOTAL OF 36 CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS A 'TRAILING THROMBUS'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285678 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF LEFT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 3 CM FROM THE SFJ. THE DIAMETER PRE RFA WAS 10 MM SFJ, 12 MM PROX THIGH, 6.6 MM MID-THIGH. A TOTAL OF 55 CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY THE PHYSICIAN AS 'LOOSELY ATTACHED IN GSV NOT EXTENDING'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285614 ↗
• InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT HAD TREATMENT OF RIGHT LEG USING A CLOSUREFAST CATHETER ALONG WITH AN RFG3 RADIOFREQUENCY GENERATOR. THE LESION WAS A DISTANCE OF 2.85 CM FROM THE SFJ. THE DIAMETER PRE RFA WAS 8.4 MM SFJ, 7.9 MM PROX THIGH, 7.2 MM MID-THIGH. A TOTAL OF 51 CM WAS TREATED. PATIENT DEVELOPED ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1 - DESCRIBED BY PHYSICIAN AS A 'TRAILING THROMBUS'. PATIENT WAS TREATED WITH EITHER LOVENOX AND/OR XYRALTA. PATIENT REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 7285571 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED THE RFG3 GENERATOR ALONG WITH A CLOSUREFAST CATHETER TO TREAT THE GREAT SAPHENOUS VEIN AS PER IFU. THE DEVICE WAS NOT REPROCESSED. IT WAS REPORTED THAT THE VEIN DID NOT CLOSE. ON THE FOLLOW UP ULTRASOUND, AN EHIT WAS PRESENT. IT WAS REPORTED THAT NO THROMBOTIC MEDICATION WAS PRESCRIBED. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Thrombus

  MAUDE report 7120426 ↗
• InjuryDec 4, 2017Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE A RFG3 GENERATOR WITH A CF7-7-60 CLOSUREFAST CATHETER TO TREAT A VENOUS INSUFFICIENCY IN THE GSV. THE TOUCH SCREEN OF THE DEVICE WAS NOT WORKING AND A SOUND WAS EMITTED FROM THE DEVICE WHEN THE PHYSICIAN STARTED A 20 SECOND CYCLE. THE PHYSICIAN UNPLUGGED AND RE-PLUGGED IN THE MACHINE BUT THE ERROR REMAINED. ANOTHER RFG3 GENERATOR WAS USED TO COMPLETE THE TREATMENT. ISSUES WITH THIS GENERATOR WERE REPORTED TO HAVE OCCURED INTERMITTENTLY OVER A PERIOD IF A WEEK BUT IN THE LAST 3-4 DAYS IT IS REPORTED THAT DEVICE SUBSEQUENTLY STOPPED FUNCTIONING. TWO CASES OF ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) REPORTED NO PATIENT INFORMATION IS AVAILABLE

  Patient problems: Thrombosis

  MAUDE report 7078441 ↗
• InjurySep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT IS REPORTED THAT OUT OF 55 RADIO-FREQUENCY ABLATION CASES OF THE GREAT SAPHENOUS VEIN (GSV), PHYSICIAN HAS OBSERVED 7 CASES OF ENDOTHERMAL HEAT INDUCED THROMBOSIS (EHIT) - CLASS 1. ALL 7 PROCEDURES WERE COMPLETED USING THIS GENERATOR AND CF7-7-60 CLOSUREFAST CATHETERS. NO INDIVIDUAL PATIENT INFORMATION AVAILABLE AS THESE INCIDENTS WERE NOT REPORTED AS THEY HAPPENED BUT PROVIDED IN THE FORM OF A STATEMENT MADE BY THE PHYSICIAN. THESE PROCEDURES WERE CARRIED OUT WITHIN THE LAST 3 MONTHS. NO CATHETER LOT NUMBERS AVAILABLE. ALL PATIENTS WHO WERE OBSERVED TO HAVE EHIT WERE TREATED WITH LOVENOX (ANTICOAGULANT MEDICATION) AND/OR XYRALTO (ANTICOAGULANT MEDICATION). ALL PATIENTS ARE REPORTED TO BE FINE.

  Patient problems: Thrombus

  MAUDE report 6850965 ↗
• MalfunctionSep 5, 2017Failure to Shut Off; Failure to Shut Off

  PHYSICIAN USED AN RFG3 WITH A RFS STYLET FOR THE VEIN CLOSURE TREATMENT OF A PERFORATOR VEIN. IT IS REPORTED THE TOUCH SCREEN IN THIS GENERATOR WOULD NOT RESPOND. WHEN PRESSED, THE GENERATOR WOULD NOT STOP TREATMENT. THE POWER BUTTON WAS PRESSED TO POWER OFF THE GENERATOR. PERFORATOR VEIN SUCCESSFULLY TREATED AND CLOSED. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6843928 ↗
• InjuryJul 11, 2017Temperature Problem; Temperature Problem

  THE PHYSICIAN INTENDED TO USE THE RFG3 TO SUCCESSFULLY TREAT THE GREAT SAPHENOUS VEIN AS PER IFU. IT WAS REPORTED THE RFG3 ACOUSTIC SIGNAL OF THE GENERATOR AND THE SECONDS' INDICATOR ARE NOT SYNCHRONIZED. ALSO THE CONNECTION OF THE CATHETER INTO THE GENERATOR DOES NOT WORK SMOOTHLY. THE PHYSICIAN STATED THAT HE DOES NOT KNOW IF THIS HAS LED TO A WRONG DELIVERY OF ENERGY, AND THEREFORE IF THIS MIGHT HAVE CAUSED THE SKIN BURN TO THE PATIENT. THE PATIENT COMPLAINED OF ITCHING AT THE ACCESS SITE. THREE WEEKS POST PROCEDURE THE PATIENT PRESENTED WITH A SKIN BURN WITH NECROSIS TO THE GROIN AREA.

  Patient problems: Burn(s); Patient Problem/Medical Problem

  MAUDE report 6704577 ↗