ClosureRFG RFG3 (UDI 10884521713444)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521713444), received between Jun 17, 2020 and Dec 15, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 10161827 ↗