ClosureFast™ CF6-8-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000552176), received between Dec 11, 2023 and Sep 16, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Overheating of Device; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785609 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem; Overheating of Device; Connection Problem

  IT WAS REPORTED THAT THE CLOSUREFAST CATHETER WAS NOT RESPONDING AND WAS NOT RECOGNIZED BY THE RADIOFREQUENCY GENERATOR DURING A PROCEDURE FOR VENOUS INSUFFICIENCY. THE GENERATOR DISPLAYED THE MESSAGE: "THE CONNECTED DEVICE IS UNSUPPORTED. PLEASE CONNECT ANOTHER DEVICE." THERE WAS DAMAGE TO THE CATHETER PLUG, IT WAS JUST NOT RECOGNIZED BY THE RADIOFREQUENCY GENERATOR. THE RED MARK WAS ALIGNED WHEN THE CONNECTOR WAS INSERTED INTO THE GENERATOR. NO BENT PINS, ALL PINS REMAINED ON THE CATHETER CONNECTOR AND THE RFG SOCKET WAS INSPECTED. THE SOFTWARE VERSION ON THE GENERATOR WAS RADIO FREQUENCY GENERATOR 3 VERSION 1.14.2. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE PROBE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696960 ↗
• MalfunctionMar 18, 2026Overheating of Device

  IT WAS REPORTED THAT DURING USE OF THE CLOSUREFAST CATHETER, THE DEVICE REACHED A TEMPERATURE OF 140 DEGREES INSTEAD OF THE INTENDED 120 DEGREES. THE LUMEN WAS FLUSHED PRIOR TO USE, INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE, AND A GUIDEWIRE WAS USED FOR INSERTION. THE GENERATOR WAS REPORTED TO WORK FINE WITH OTHER CLOSUREFAST CATHETERS. THE PROCEDURE WAS COMPLETED BY USING ANOTHER CATHETER, AND NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS ARESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626115 ↗
• MalfunctionMar 3, 2026Output Problem

  IT WAS REPORTED THAT THE CLOSUREFAST CF6-8-100 CATHETER WAS USED TO TREAT VENOUS INSUFFICIENCY. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. LUMEN WAS FLUSHED PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CL OSUREFAST CF6-8-100 CATHETER NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE PROBE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496584 ↗
• MalfunctionDec 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A PHYSICIAN WAS PERFORMING SUPERFICIAL VEIN TREATMENT USING A CLOSUREFAST CATHETER AND THE HEATING WENT UP ABOVE THE TYPICAL THRESHOLD AND THE ERROR MESSAGE "DISCONNECT CATHETER" WAS DISPLAYED ON THE GENERATOR. THE DEVICE WAS PREPPED AS PER THE IFU. COMPRESSION WAS USED WITHIN NORMAL LIMITS. NO DAMAGE WAS NOTED TO THE COIL. NO COAGULANT BUILD UP ON THE HEATING ELEMENT. A REPLACEMENT CLOSUREFAST CATHETER WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863868 ↗
• MalfunctionDec 15, 2025Overheating of Device; Output Problem; Overheating of Device; Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CLOSUREFAST CATHETER, THE TEMPERATURE REACHED ALMOST 147°C, THE RADIO FREQUENCY GENERATOR SHUT OFF, AND ERROR CODE 350 WAS DISPLAYED ON THE GENERATOR, RESULTING IN THE PROCEDURE BEING ABORTED. NO VISIBLE DAMAGE TO THE CATHETER WAS SEEN. COMPRESSION WAS APPLIED OVER THE AREA BEING TREATED. THE PROBLEM PERSISTED. THE DEVICE WAS USED TO TREAT THE PROXIMAL SEGMENT OF THE RIGHT GREAT SAPHENOUS VEIN IN A PERIPHERAL VEIN. THE LUMEN WAS FLUSHED PRIOR TO USE, TUMESCENT INFILTRATION AND HAND/MANUAL COMPRESSION WERE UTILIZED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND NO SEGMENTS WERE TREATED. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803605 ↗
• MalfunctionAug 6, 2025Overheating of Device; Deformation Due to Compressive Stress; Overheating of Device; Deformation Due to Compressive Stress

  A PHYSICIAN USED A CLOSUREFAST CATHETER TO TREAT A PATIENTS LEFT GREAT SAPHENOUS VEIN. IT WAS REPORTED THAT POST USE OF THE CLOSUREFAST CATHETER, A KINK ON THE COIL AND BUBBLING OF THE FEP LINER WERE OBSERVED. THE LUMEN WAS FLUSHED PRIOR TO USE, TUMESCENT INFILTRATION AND HAND/MANUAL COMPRESSION WERE UTILIZED, AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. NO VESSEL TORTUOSITY OR CALCIFICATION WERE PRESENT. PROPER TEMPERATURE WAS REACHED. THERE WERE NO ERROR MESSAGES/CODES/WARNINGS DISPLAYED. IT WAS A VERY UNEVENTFUL PREP, CATHETER PLACEMENT AND TREATMENT. NO DIFFICULTY PLACING IT AND NO TRAUMA TO THE CATHETER. PHYSICIAN DID HAVE TO APPLY ADDITIONAL TUMESCENT AT ONE POINT IN THE MID-THIGH REGION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PHYSICIAN DIDN¿T NOTICE ANYTHING OUT OF THE ORDINARY UNTIL THE CATHETER WAS TAKEN OUT AND NOTICED THE HOUSING OF THE CATHETER HAD MELTED. ONE SEGMENT WAS TREATED, THE VEIN CLOSED, AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO VESSEL DAMAGE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724651 ↗
• MalfunctionJul 29, 2025Overheating of Device; Difficult to Remove; Deformation Due to Compressive Stress; Overheating of Device; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING TREATMENT OF VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN USING THE CLOSURE FAST CATHETER, THERE WAS TROUBLE REMOVING THE CATHETER FROM THE LEG AS IT BECAME CAUGHT AND TETHERED AT THE ENTRY POINT. UPON REMOVAL, THE CATHETER'S HEATING ELEMENT APPEARED BENT OR KINKED, AND COAGULUM HAD BUILT UP AROUND THE BEND OF THE HEATING ELEMENT. THE PROCEDURE WAS NEARING COMPLETION WITH ALL REQUIRED SEGMENTS TREATED, AND THE INTRODUCER SHEATH PROTOCOL WAS FOLLOWED AS PER INSTRUCTIONS FOR USE, WITH THE SHEATH NOT COVERING THE HEATING ELEMENT AT ANY POINT. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. THE GENERATOR DID NOT DISPLAY ANY WARNINGS, AND THE VEIN WAS CONFIRMED CLOSED. NO ADDITIONAL TREATMENT WAS REQUIRED. NO DEATHS, INFECTIONS, OR OTHER ADVERSE OUTCOMES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644403 ↗
• MalfunctionDec 9, 2024Overheating of Device; Overheating of Device

  PHYSICIAN ATTEMPTED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF THE PATIENTS RIGHT DISTAL GREAT SAPHENOUS VEIN (GSV). MINIMAL VESSEL TORTUOSITY WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE LUMEN WAS FLUSHED PRIOR TO USE. A GUIDEWIRE WAS NOT USED FOR INSERTION OF CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. NO ANESTHESIA WAS UTILIZED. HAND COMPRESSION WAS UTILIZED. IT WAS REPORTED THE CATHETER WAS USED SUCCESSFULLY FOR 12 TREATMENT CYCLES, THEN THEY WERE UNABLE TO REACH TARGET TEMPERATURE. AFTER REMOVING THE CATHETER IT WAS VISUALLY EVIDENT THAT THE TIP OF THE HEATING ELEMENT HAD BURNT UP, THE COIL WAS NOT EXPOSED AND THERE WAS NO COAGULANT BUILD-UP ON THE HEATING ELEMENT. NO ERROR MESSAGES/CODES/WARNINGS WERE DISPLAYED ON THE RFG. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, NO VESSEL DAMAGE WAS NOTED. A REPLACEMENT CLOSUREFAST CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE VEIN IS REPORTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20876953 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER DURING TREATMENT OF THE PATIENTS LEFT PROXIMAL GREAT SAPHENOUS VEIN (GSV). POST OP, EHIT KABNICK CLASS 2 PROPAGATION INTO THE COMMON FEMORAL VEIN (CFV) AND OCCUPATION OF A CROSS-SECTIONAL AREA OF LESS THAN 50% WAS FOUND IN THE SAPHENO-FEMORAL JUNCTION (SFJ). THE ONSET OF SYMPTOMS WAS DIRECTLY AFTER PROCEDURE (WITHIN SAME DAY). THE PATIENT WAS PRESCRIBED ELOQUIS 5MG TWICE DAILY FOR 28 DAYS. THERE ARE NO KNOWN PATIENT ALLERGIES. THERE ARE NO KNOWN CO-MORBIDITIES. ISSUE IS STILL PRESENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20784062 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLOSUREFAST RFA CATHETER WAS USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV). TUMESCENT INFIL TRATION AND LOCAL ANESTHESIA WAS USED. THE VEIN CLOSED IT WAS REPORTED POST-OP THE PATIENT HAS A DEEP VEIN THROMBOSIS (DVT).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20450758 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLOSUREFAST RFA CATHETER WAS USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV). TUMESCENT INFIL TRATION AND LOCAL ANESTHESIA WAS USED. THE VEIN CLOSED IT WAS REPORTED POST-OP THE PATIENT HAS A DEEP VEIN THROMBOSIS (DVT).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20450633 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLOSUREFAST RFA CATHETER WAS USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV). TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WAS USED. THE VEIN CLOSED IT WAS REPORTED POST-OP THE PATIENT HAS A DEEP VEIN THROMBOSIS (DVT).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20450559 ↗
• MalfunctionOct 7, 2024Delivered as Unsterile Product; Defective Device; Delivered as Unsterile Product; Defective Device

  A CLOSUREFAST RFA CATHETER WAS INTENDED TO BE USED. IT WAS REPORTED DURING PRE-OP THE OUTER BOX WAS DAMAGED AND THE STERILE PACKAGING INSIDE WAS OPEN FROM THE CORNER. NO LABELLING ISSUES OR MISSING COMPONENTS. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382447 ↗
• MalfunctionDec 11, 2023Overheating of Device; Deformation Due to Compressive Stress; Overheating of Device; Deformation Due to Compressive Stress

  A CLOSUREFAST RFA CATHETER WAS  USED WITH AN RFG3 FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV) . THE LUMEN WAS FLUSHED PRIOR TO USED. THE IFU WAS FOLLOWED. THE APPROPRIATE TEMPERATURE WAS REACHED. IT WAS REPORTED AT THE END OF THE PROCEDURE , WHEN FINISHING THE LAST VEIN SEGMENT THE CATHETER KINKED AND ONCE IT WAS REMOVED FROM THE PATIENT THE HEATING ELEMENT WAS ALSO NOTED TO BE DAMAGED WITH THE COIL EXPOSED. NO ERROR MESSAGES/CODES/WARNINGS DISPLAYED ON THE RFG. THE VEIN CLOSED AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301748 ↗