ClosureRFGRecalls & reported problems across all models

We found 3 models of ClosureRFG by Covidien LP in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Apr 14, 2026 — classified as 29 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ClosureRFG problems

ClosureRFG models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ClosureRFG RFG3

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  25 reports
• ClosureRFG RFG3

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  8 reports
• ClosureRFG RFG2

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  5 reports

Recent ClosureRFG adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• InjuryDec 15, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  PHYSICIAN ATTEMPTED TO USE AN RFG3 GENERATOR DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). TUMESCENT INFILTRATION WAS NOT UTILIZED. GENERAL ANESTHESIA WAS USED. NO COMPRESSION WAS USED. THE GENERATOR IS POWERING ON. A DISPLAY ISSUE OCCURRED. IT WAS REPORTED THE ERROR MESSAGE ¿ERROR 47¿ WAS DISPLAYED ON GENERATOR AND DESPITE FOLLOWING INSTRUCTIONS ON THE SCREEN TO POWER OFF AND ON SEVERAL TIMES, THE ERROR PERSISTED AND THE CATHETER WAS NOT RECOGNISED AND WOULD NOT FUNCTION. THERE IS NO PHYSICAL DAMAGE TO ANY PART OF THE GENERATOR. THE CUSTOMER DID NOT CONTINUE WITH THE PROCEDURE. THE PATIENT WAS TREATED WITH AN OPEN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333949 ↗
• 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 ↗
• MalfunctionJan 4, 2023Electrical /Electronic Property Problem; Noise, Audible; Electrical /Electronic Property Problem; Noise, Audible

  IT IS REPORTED AN RFG3 IS RETURNING FOR SERVICE AND REPAIR. IT IS REPORTED WHEN DEVICE WAS TURNED ON IT STARTED TO POP/RATTLE AND EMIT SMOKE. THERE IS PHYSICAL DAMAGE TO THE GENERATOR. IT LOOKS LIKE THE DEVICE WAS DROPPED AT SOME POINT PRIOR TO THE EVENT. THE DEVICE WAS ISOLATED IMMEDIATELY AFTER THIS EVENT. A REPLACEMENT GENERATOR WAS USED TO COMPLETE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093763 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER WITH AN RFG3 DURING TREATMENT OF THE PATIENT'S RIGHT GREAT SAPHENOUS (GSV). IFU WAS FOLLOWED. PROPER TEMPERATURE WAS REACHED. NO PARAMETERS OF THE RFG3 WERE CHANGED. THE VEIN IS REPORTED TO HAVE CLOSED. 7 DAYS POST PROCEDURE DURING FOLLOW-UP, EHIT WAS IDENTIFIED 2.3MM FROM THE SAPHENOUS FEMORAL JUNCTION (SFJ). THE PATIENT WAS PRESCRIBED CONTINUATION OF ASA TREATMENT. NO FURTHER INJURY REPORTED.

  Patient problems: Injury; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10808908 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER WITH AN RFG3 DURING TREATMENT OF THE PATIENT'S RIGHT GREAT SAPHENOUS (GSV). . IFU WAS FOLLOWED. PROPER TEMPERATURE WAS REACHED. NO PARAMETERS OF THE RFG3 WERE CHANGED. THE VEIN IS REPORTED TO HAVE CLOSED. 8 DAYS POST PROCEDURE DURING FOLLOW-UP, EHIT WAS IDENTIFIED 11.5MM FROM THE SAPHENOUS FEMORAL JUNCTION (SFJ). THE PATIENT WAS PRESCRIBED PLAVIX 75MG DAILY. NO FURTHER INJURY REPORTED.

  Patient problems: Injury; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10808861 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER WITH AN RFG3 DURING TREATMENT OF THE PATIENT'S RIGHT GREAT SAPHENOUS VEIN(GSV) AND ANTERIOR GSV . IFU WAS FOLLOWED. PROPER TEMPERATURE WAS REACHED. NO PARAMETERS OF THE RFG3 WERE CHANGED. THE VEIN IS REPORTED TO HAVE CLOSED. 8 DAYS POST PROCEDURE DURING FOLLOW-UP, EHIT WAS IDENTIFIED TRAILING 3MM FROM THE COMMON FEMORAL VEIN (CFV). THE PATIENT WAS PRESCRIBED 325 MG ASA AND WILL RETURN FOR REPEAT DUPLEX IN 1 WEEK. NO FURTHER INJURY REPORTED.

  Patient problems: Injury; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10808843 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER WITH AN RFG3 DURING TREATMENT OF THE PATIENT'S LEFT GREAT SAPHENOUS (GSV). IFU WAS FOLLOWED. PROPER TEMPERATURE WAS REACHED. NO PARAMETERS OF THE RFG3 WERE CHANGED. THE VEIN IS REPORTED TO HAVE CLOSED. 7 DAYS POST PROCEDURE DURING FOLLOW-UP, EHIT WAS IDENTIFIED TRAILING INTO THE COMMON FEMORAL VEIN (CFV). THE PATIENT WAS PRESCRIBED 81MG ASA AND WILL RETURN FOR REPEAT DUPLEX IN 1 WEEK. NO FURTHER INJURY REPORTED.

  Patient problems: Injury; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10808829 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER WITH AN RFG3 DURING TREATMENT OF THE PATIENT'S LEFT GREAT SAPHENOUS (GSV). IFU WAS FOLLOWED. PROPER TEMPERATURE WAS REACHED. NO PARAMETERS OF THE RFG3 WERE CHANGED. THE VEIN IS REPORTED TO HAVE CLOSED. 7 DAYS POST PROCEDURE DURING FOLLOW-UP, EHIT WAS IDENTIFIED 6CM FROM THE COMMON FEMORAL VEIN (CFV). THE PATIENT WAS PRESCRIBED 81MG ASA AND WILL RETURN FOR REPEAT DUPLEX IN 1 WEEK. NO FURTHER INJURY REPORTED.

  Patient problems: Injury; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10808811 ↗
• 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 ↗
• 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 10161827 ↗
• 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 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 ↗

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