ClosureFast™ CF7-7-60 (UDI 00643169862968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00643169862968), received between Dec 12, 2017 and Feb 7, 2025 — classified as 18 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (29 reports).

2 other recalls cover devices cleared under the same FDA submission (K061373); they may or may not involve this specific model.

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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  A COLOURFAST RFA CATHETER WAS INTENDED TO BE USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). LOCAL ANESTHESIA, HAND COMPRESSION AND TUMESCENT INFILTRATION WERE USED. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED. IT WAS REPORTED THE CATHETER WAS NOT RESPONDING/RECOGNISED. NO MESSAGE DISPLAYED, ONLY THE START UP PAGE DISPLAYED. THE GENERATOR WAS POWER-CYCLED AND THE ERROR REMAINED. ANOTHER CATHETER WAS USED WITH THE SAME GENERATOR WITHOUT ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333043 ↗
• MalfunctionFeb 5, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CLOSUREFAST CF7-7-60 CATHETER, BLOOD WAS OBSERVED COMING OUT OF THE TIP OF THE WHITE CAP (HUB/LEUR) ON THE BACK OF THE CATHETER, DESPITE IT BEING SCREWED ON. A HOLE WAS IDENTIFIED AT THE TIP OF THE CAP. THE CATHETER WAS INSERTED INTO THE PERIPHERAL VEIN, SPECIFICALLY THE GREAT SAPHENOUS VEIN (GSV) ON THE RIGHT SIDE AT THE MID-LOCATION. THE CATHETER WAS SAFELY REMOVED, AND A NEW CLOSUREFAST CF7-7-60 CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE INVOLVED THEUSE OF LOCAL ANESTHESIA, TUMESCENT INFILTRATION, AND HAND/MANUAL COMPRESSION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW CATHETER, AND THE VEIN WAS CLOSED AFTER FOUR RADIOFREQUENCY CYCLES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THISEVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311454 ↗
• MalfunctionJan 29, 2025Overheating of Device; Overheating of Device

  PHYSICIAN ATTEMPTED TO USE A CLOSURE FAST ABLATION DEVICE FOR PATIENT TREATMENT IN THE GREAT SAPHENOUS VEIN (GSV). LOCAL ANESTHESIA WAS USED. IFU WAS FOLLOWED. MODEL AND SERIAL NUMBER OF GENERATOR OF GENERATOR USED WAS RFG2. IT WAS REPORTED THAT THE CATHETER TERMINAL WAS BURNT. THE DEVICE WAS REPLACED AND USED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262472 ↗
• MalfunctionDec 2, 2024Overheating of Device; Overheating of Device

  PHYSICIAN ATTEMPTED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. PROPER TEMPERATURE WAS REACHED. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. DAMAGE TO THE WORKING SECTION OF THE CATHETER WAS REPORTED, WHEN REMOVED FROM THE PATIENT'S BODY AFTER THE OPERATION, IT LOOKED LIKE IT WAS BURNED AND TO BE MELTED. NO PART OF THE COIL WAS EXPOSED AND NO ERROR MESSAGES/CODES/WARNINGS WERE DISPLAYED ON THE RFG. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND NO VESSEL DAMAGE WAS REPORTED. THIS ISSUE IS REPORTED FOR 2 CATHETERS. A NEW CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 2 SEGMENTS WERE TREATED AND THE VEIN IS REPORTED TO HAVE CLOSED. NO ADDITIONAL TREATMENT REQUIRED AND NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE COIL WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819639 ↗
• MalfunctionSep 6, 2024Overheating of Device; Overheating of Device

  A PHYSICIAN ATTEMPTED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF THE PATIENTS PROXIMAL GREAT SAPHENOUS VEIN (GSV). 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. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS UTILIZED. HAND COMPRESSION WAS UTILIZED. A TEMPERATURE ISSUE WAS REPORTED. THE CATHETER OVERHEATED TO 140 DEGREES WITH NO WATTAGE OUTPUT. THERE WERE NO ADJUSTMENTS MADE TO THE PARAMETERSOF THE GENERATOR. THERE WERE NO ERROR MESSAGES DISPLAYED ON THE GENERATOR. THE RFG WAS POWER CYCLED BUT THE ERROR REMAINED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT CLOSUREFAST CATHETER WAS USED TO COMPETE THE PROCEDURE WITHOUT ISSUE. 1 SEGMENT WAS TREATED AND THE VEIN IS REPORTED TO HAVE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157591 ↗
• InjuryAug 15, 2024Output Problem; Output Problem

  A CLOSUREFAST RFA CATHETER WAS INTENDED TO BE USED WITH AN RFG2 FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). LOCAL ANESTHESIA AND HAND COMPRESSION WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED THE CATHETER FAILED TO REACH THE APPROPRIATE TEMPERATURE. SURGICAL TREATMENT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990506 ↗
• MalfunctionMay 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS RIGHT DISTAL SHORT SAPHENOUS VEIN (SSV). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THE CLOSUREFAST CATHETER WAS PLUGGED INTO THE GENERATOR AND IT FIRED WITHOUT BEING PRESSED. PATIENT WAS NOT TUMESCED YET AND FELT THE HEAT. THE RFG HAS BEEN USED SUCCESSFULLY AGAIN WITHOUT ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369116 ↗
• MalfunctionMar 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSUREFAST CATHETER. IFU WAS FOLLOWED. WHEN OPENING THE PACKAGE, PHYSICIAN NOTICED SMALL OPENING AT CORNER OF PACKAGE. PHYSICIAN OPENED NEW CATHETER TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838371 ↗
• MalfunctionJan 26, 2024Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. NO DAMAGE NOTED TO THE OUTER PACKAGING AND THE STERILE PACKAGING WAS INTACT. IT IS REPORTED AFTER OPENING THE PACKAGE OF THE CATHETER, IT WAS FOUND THAT THE ROOT OF THE HEATING ELEMENT AT THE TIP END WAS BROKEN AND HAD COME UNGLUED. THE SURGEON TRIED TO IMPLANT IT INTO THE PATIENT TO SEE IF IT COULD BE HEATED TO COMPLETE THE WORK. AFTER IMPLANTATION, IT WAS FOUND THAT THE CATHETER COULD NOT REACH THE WORKING TEMPERATURE AND WAS STAINED WITH BIOLOGICAL TISSUE. A NEW CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE VEIN IS REPORTED TO HAVE CLOSED. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587445 ↗
• MalfunctionJan 4, 2024Overheating of Device; Overheating of Device

  PHYSICIAN ATTEMPTED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. NO GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. NO COMPRESSION WAS USED. A CATHETER TEMPERATURE THERMOCOUPLE ISSUE WAS NOTED. IT WAS REPORTED THAT THE COIL UNRAVELED. THERE WERE ISSUES NOTED WHEN WITHDRAWING CATHETER. WHEN REMOVING THE CATHETER, THERE WAS ADHESION AND BLOOD SCAB AT THE TIP, THE OUTER SKIN OF THE COIL WAS DAMAGED, AND IT WAS UNCERTAIN WHETHER THE METAL WIRE WAS IN DIRECT CONTACT WITH THE ENDOTHELIUM OF THE BLOOD VESSEL. NO VESSEL DAMAGE WAS REPORTED. THERE WERE NO ERROR CODES/MESSAGES/WARNINGS FROM THE GENERATOR. A REPLACEMENT CATHETER WAS OPENED AND USED TO COMPLETE PROCEDURE. 4 SEGMENTS WERE TREATED AND THE VEIN IS REPORTED TO HAVE CLOSED SUCCESSFULLY. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443867 ↗
• InjuryDec 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CLOSUREFAST CATHETER WAS USED WITH AN RFG3 FOR TREATMENT OF THE GREAT SAPHENOUS VEIN ((B)(3) 2023). LOCAL ANESTHESIA WAS USED. TUMESCENT INFILTRATION WAS USED AND TRANSDUCER COMPRESSION. IT WAS REPORTED AT THE BEGINNING OF THE TREATMENT THE GENERATOR SHOWED UNREALISTIC NUMBERS (EXTREMELY HIGH AND THEN EXTREMELY LOW) AND SHOWED A DEVICE DEFECT. THE GENERATOR HAS BEEN USED SUCCESSFULLY SINCE. THE CATHETER WAS CHANGED. 21 CYCLES WERE CARRIED OUT AND THE VEIN CLOSED. ULTRASOUND TWO DAYS AFTER TREATMENT SHOWED EHIT 2 PATIENT WAS PRESCRIBED HEPARIN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18356727 ↗
• MalfunctionDec 18, 2023Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FOLLOWED. IT WAS REPORTED THE VESSEL HAD A TORTUOUS SECTION. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT AND BACK LOADED THE GLIDE WIRE THROUGH THE PORT IN THE HANDLE AND THE WIRE BECOME STUCK APPROXIMATELY 2/3 OF THE WAY THROUGH THE LUMEN OF THE CATHETER. THE PHYSICIAN  REMOVED THE WIRE AND FLUSHED THE CATHETER AND RE-INSERTED THE WIRE THROUGH THE HANDLE A SECOND TIME AND THE WIRE STOPPED AT THE SAME LOCATION AS THE FIRST TIME. IT WAS THEN ATTEMPTED TO REMOVE THE WIRE BUT THE WIRE WOULD NOT MOVE. FORCE WAS APPLIES AND THE CATHETER CAME APART/SHREDDED.  THE WIRE IS STILL IMBEDDED IN THE THE CATHETER. A SECOND CATHETER WAS USED TO TREAT THE GSV IN TWO SECTIONS TO AVOID NAVIGATING THROUGH THE TORTUOUS SECTION. NO PATEINT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344175 ↗
• MalfunctionSep 27, 2023Overheating of Device; Output Problem; Overheating of Device; Output Problem

  A CLOSUREFAST CATHETER WAS BEING USED WITH AN RFG3 FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). 8 SEGMENTS WERE TREATED. TUMESCENT INFILTRATION WAS USED. LOCAL ANESTHESIA AND HAND COMPRESSION WAS USED. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED. IT WAS REPORTED AFTER 4 CYCLED THE COIL MELTED. THE GENERATOR DISPLAYED A MESSAGE STATING THE TEMPERATURE COULD NOT BE REACHED. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825505 ↗
• MalfunctionSep 11, 2023Difficult to Insert; Difficult to Insert

  A CLOSUREFAST RFA CATHETER WAS INTENDED TO BE USED. THE IFU WAS FOLLOWED. IT WAS REPORTED WHEN THE OPERATOR REMOVED THE CATHETER FROM THE BOX, THE HEATING COULD APPEARED THICK AND UNUSUAL. THE OPERATOR WAS UNABLE TO INSERT THE CATHETER INTO THE INTRODUCER SHEATH DUE TO THE HEATING COIL THICKNESS. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE COIL OF THE DEVICE WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720479 ↗
• MalfunctionJul 27, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSUREFAST TO TREAT A LESION IN THE GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED.  IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE SPLIT AFTER A RUN OF ABLATIONS, DETACHMENT DID NOT OCCUR. OBVIOUS DAMAGE APPROX. 10CM FROM THE TIP WAS PRESENT, BUBBLING OF THE LINER AND THE COIL WAS SEEMINGLY EXPOSED. PROCEDURE COMPLETED USING ANOTHER CLOSUREFAST. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410331 ↗
• MalfunctionJul 24, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION WAS UTILIZED. GENERAL ANESTHESIA WAS USED. TRANSDUCER COMPRESSION WAS USED. PROPER TEMPERATURE WAS REACHED. A KINK ON THE OUTER SHAFT OF CATHETER WAS NOTED UPON REMOVAL/WITHDRAWAL. A REPLACEMENT CATHETER WAS USED TO COMPLETE PROCEDURE. 1 SEGMENT WAS TREATED AND THE VEIN IS REPORTED TO HAVE CLOSED. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS SENT FOR EVALUATION, IT WAS NOTED THAT THE HEATING ELEMENT OF THE COIL WAS REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377449 ↗
• InjuryJul 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). MODERATE VESSEL TORTUOSITY IS REPORTED. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION UTILIZED. LOCAL ANESTHESIA WAS USED. IT WAS REPORTED AFTER THE TREATMENT OF 11 ABLATIONS IN ONE LEG IN A BILATERAL CASE, AN ATTEMPT WAS MADE TO PERFORM ABLATION ON THE OTHER LEG, BUT THE ADVISORY MESSAGE "THE CONNECTED DEVICE IS BROKEN. PLEASE CONNECT ANOTHER DEVICE." WAS DISPLAYED ON GENERATOR. A NEW CATHETER WAS OPENED AND ATTEMPTED TO BE USED WITH THE SAME GENERATOR AND ABLATION COULD BE PERFORMED ONCE, BUT FROM THE SECOND TIME ONWARD, THE ADVISORY MESSAGE "THE CONNECTED DEVICE IS BROKEN. PLEASE CONNECT ANOTHER DEVICE." WAS DISPLAYED ON GENERATOR AGAIN. ABLATION WAS STOPPED, AND UPON OBTAINING THE PATIENT'S APPROVAL THE SURGICAL PROCEDURE WAS CHANGED TO STRIPPING TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341211 ↗
• InjuryJul 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). MODERATE VESSEL TORTUOSITY IS REPORTED. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION UTILIZED. LOCAL ANESTHESIA WAS USED. IT WAS REPORTED AFTER THE TREATMENT OF 11 ABLATIONS IN ONE LEG IN A BILATERAL CASE, AN ATTEMPT WAS MADE TO PERFORM ABLATION ON THE OTHER LEG, BUT THE ADVISORY MESSAGE "THE CONNECTED DEVICE IS BROKEN. PLEASE CONNECT ANOTHER DEVICE." WAS DISPLAYED ON GENERATOR. A NEW CATHETER WAS OPENED AND ATTEMPTED TO BE USED WITH THE SAME GENERATOR AND ABLATION COULD BE PERFORMED ONCE, BUT FROM THE SECOND TIME ONWARD, THE ADVISORY MESSAGE "THE CONNECTED DEVICE IS BROKEN. PLEASE CONNECT ANOTHER DEVICE." WAS DISPLAYED ON GENERATOR AGAIN. ABLATION WAS STOPPED, AND UPON OBTAINING THE PATIENT'S APPROVAL THE SURGICAL PROCEDURE WAS CHANGED TO STRIPPING TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341191 ↗
• MalfunctionJul 5, 2023Overheating of Device; Overheating of Device

  IT IS REPORTED A CUSTOMER EXPERIENCED AN ISSUE WITH A CLOSUREFAST CATHETER. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST -PROCEDURE. LOCAL ANESTHESIA W WAS USED. TUMESCENT INFILTRATION WAS UTILIZED. ONE SEGMENT WAS TREATED. THE COATING ON THE CATHETER SEEMED DAMAGED. COMPRESSION HAD BEEN APPLIED WHEN THE ISSUE OCCURRED. THERE WERE NO ALERT/ERROR MESSAGE OBSERVED ON THE RFG BUT IT WAS REPORTED THE WATTAGE READINGS WERE SOMEWHAT ABNORMAL ON THE RFG. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254000 ↗
• MalfunctionMay 10, 2023Overheating of Device; Overheating of Device

  A PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER DURING PATIENT TREATMENT. IFU WAS FOLLOWED. IT IS REPORTED PHYSICIAN WAS ABLE TO INSERT CATHETER INTO PATIENT BUT THE OTHER END WOULD NOT PLUG INTO THE CONSOLE. THE RED MARK ALIGNED WHEN THE CONNECTOR WAS INSERTED INTO THE GENERATOR. PINS WERE NOT BENT. IT IS UNCERTAIN IF ALL PINS REMAINED ON THE CATHETER CONNECTOR. A REPLACEMENT CATHETER WAS OPENED AND USED WITHOUT ISSUE TO COMPLETE PROCEDURE. DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902448 ↗
• InjuryApr 14, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER TO TREAT THE GREAT SAPHENOUS VEIN (GSV) IN A PATIENT. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. IT WAS REPORTED THAT THE CATHETER WAS NOT RESPONDING/ RECOGNIZED WHEN CONNECTED TO GENERATOR. ERROR CODE 475 WAS DISPLAYED ON GENERATOR. THE GENERATOR WAS POWER-CYCLED MANY TIMES AND THE ERROR REMAINED. A NEW CATHETER WAS OPENED AND USED WITH THE SAME GENERATOR AND HAD THE SAME ISSUE, DID NOT RESPOND. PEEL OFF WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741866 ↗
• MalfunctionMar 13, 2023Use of Device Problem; Use of Device Problem

  AN EXPIRED CLOSUREFAST RFA CATHETER WAS USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE VEIN CLOSED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16533672 ↗
• MalfunctionMar 7, 2023Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER AND A MICRO INTRODUCER SHEATH FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. THE APPROPRIATE TEMPERATURE WAS REACHED. IT WAS REPORTED AFTER TREATMENT OF THE GSV, THE CUSTOMER TRIED TO PULL OUT THE CATHETER THROUGH THE SHEATH, BUT WAS UNABLE . THE PHYSICIAN HAD TO PULL THE SHEATH AND THE CATHETER TOGETHER AND NOTED THAT THE THERMOCOUPLE WAS DESTROYED. THE WIRE WAS UNWOUND PARTLY IN THE SHEATH. ANOTHER CATHETER WAS OPENED TO CONTINUE TREATMENT OF THE SECOND VEIN. NO VISIBLE DEFECTS OR DAMAGE WERE NOTED ON THE INTRODUCER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493905 ↗
• MalfunctionJan 22, 2023Overheating of Device; Overheating of Device

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER FOR THE TREATMENT. THE IFU WAS FOLLOWED. A GUIDEWIRE WAS USED. THE APPROPRIATE TEMPERATURE WAS REACHED. IT WAS REPORTED THE PHYSICIAN PLACED THE CATHETER INTO THE PATIENTS VEIN, AFTER PULLING OUT THE RF CATHETER FROM THE VEIN THE WIRE APPEARED TO BE FAULTY AND BURNT. ANOTHER CLOSUREFAST RFA CATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221592 ↗
• MalfunctionJan 19, 2023Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT ABNORMAL CATHETER ABLATION TEMPERATURE OCCURRED. THE INITIAL ABLATION WAS SUCCESSFUL BUT IT FELT LIKE IT WAS STUCK MIDWAY AND WHEN THE CATHETER WAS REMOVED IT WAS IDENTIFIED THAT THE COIL WAS BURNT. ANOTHER CATHETER WAS OPENED AND THE REMAINING PORTION WAS ABLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061373. One submission often covers many models, so check the product and lot details in each record.

• Z-0542-2008 · Aug 8, 2007 · Terminated
  VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
• Z-0132-2008 · Mar 6, 2007 · Terminated
  VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138