ClosureFast™ CF6-8-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00763000552169), received between Jul 24, 2024 and Sep 24, 2026 — classified as 11 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (24 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Overheating of Device

  It was reported that two Closurefast catheters were attempted to be used during patient treatment. The catheter lumens were flushed prior to use. The devices were prepped as per the IFU. An abnormal catheter ablation temperature was reported for the first catheter attempted. The temperature rose to 129°C, and the wattage varied between 25~0.1W. After repeating 'High power' and 'Low power', a 'catheter broken' error message was displayed. A second Closurefast catheter was attempted to be used but upon inserting the catheter into the generator, an error message ¿catheter broken¿ displayed on the generator. A third Closurefast catheter was successfully used with the same generator to complete the procedure. No patient symptoms or complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883222 ↗
• MalfunctionSep 18, 2026Overheating of Device; Difficult to Remove; Material Deformation; Output Problem

  It was reported that a ClosureFast catheter was used for radiofrequency ablation of the great saphenous vein for venous insufficiency, during which four vein segments were treated with tumescent infiltration, local anesthesia, and hand compression. During the first segmental ablation, the radiofrequency machine displayed a ¿target temperature cannot reach¿ alert and stopped the procedure. The physician restarted the radiofrequency cycle, the alert did not recur, and the procedure was completed. During catheter removal, the catheter became stuck at the puncture site and was safely removed. Kinking and damage were observed on the catheter ablation segment. The vein closed successfully, and no additional treatment was required. No patient complications have been reported as a result of this event. No intervention was required to remove the device. The procedure was stopped once messaged said ¿target temperature cannot reach¿ popped out. After that, the procedure was completed as usual.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814620 ↗
• MalfunctionMay 19, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A PERIPHERAL VEIN CLOSURE PROCEDURE USING A CLOSUREFAST CATHETER/RFS STYLET, THERE WAS A 10-MINUTE DELAY IN SURGERY DUE TO A HIGH TEMPERATURE ISSUE. THE RIGHT GREAT SAPHENOUS VEIN IN THE MID SEGMENT WAS BEING TREATED. THE LUMEN WAS FLUSHED PRIOR TO USE, A GUIDEWIRE WAS USED FOR INSERTION, TUMESCENT INFILTRATION WAS UTILIZED, AND HAND/MANUAL COMPRESSION WAS UTILIZED. PROPER TEMPERATURE WAS NOT REACHED, AND NO ADJUSTMENTS WERE MADE TO THE GENERATOR PARAMETERS. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, NO VISIBLE DAMAGE NOTED TO THE CATHETER AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. VEIN CLOSURE WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25214072 ↗
• MalfunctionApr 3, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP THE CLOSUREFAST CATHETER CF6-8-60 CONTINUED TO HEAT EVEN THOUGH IT WAS OFF. THE RFG WAS NOT POWER-CYCLED, NO DAMAGE WAS NOTED TO THE CATHETER. THERE WAS NO PATIENT INVOLVED. A NEW CLOSUREFAST DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775833 ↗
• MalfunctionMar 24, 2026Overheating of Device

  IT WAS REPORTED THAT IT EXCEEDED 120°C, AND A DISPLAY OF 135°C APPEARED. IN ADDITION, THE NUMBER OF W (WATTAGE), BECAUSE IT WAS FOR A MOMENT, THE DISPLAY COULD NOT BE SEEN, BUT IT WAS REMEMBERED THAT THE CONTENT OF THE DISPLAY INDICATED THE TEMPERATURE WAS TOO HIGH. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681501 ↗
• MalfunctionMar 24, 2026Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT AFTER TREATING THE FIRST SEGMENT OF THE GREAT SAPHENOUS VEIN IN THE RIGHT AND LEFT PROXIMAL PERIPHERAL VEINS WITH TWO CYCLES USING THE CLOSUREFAST CATHETER, PULLBACK WAS EXPERIENCED FOR THE REMAINDER OF THE PROCEDURE. A SECOND CATHETER WAS USED. UPON REMOVAL OF THE CATHETER FROM THE PATIENT, A VISIBLE CHARRED VEIN AND COAGULATION ON THE HEATING ELEMENT WERE OBSERVED, ALONG WITH COIL DAMAGE CHARACTERIZED BY BURNT RESIDUE AND COAGULANT BUILD-UP ON THE HEATING ELEMENT. THE LUMEN WAS FLUSHED PRIOR TO USE, TUMESCENT INFILTRATION AND GENERAL ANESTHESIA WERE UTILIZED, AND COMPRESSION WITH A TRANSDUCER WAS APPLIED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO ERROR MESSAGES WERE DISPLAYED ON THE GENERATOR, AND THE DEVICES WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW DEVICE AND THE VEIN WAS CLOSED. NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DIFFICULTY IN REMOVING THE CATHETER WAS CONFIRMED FOR THE FIRST CATHETER A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673541 ↗
• MalfunctionMar 24, 2026Entrapment of Device; Overheating of Device; Difficult to Remove

  IT WAS REPORTED THAT AFTER TREATING THE FIRST SEGMENT OF THE GREAT SAPHENOUS VEIN IN THE RIGHT AND LEFT PROXIMAL PERIPHERAL VEINS WITH TWO CYCLES USING THE CLOSUREFAST CATHETER, PULLBACK WAS EXPERIENCED FOR THE REMAINDER OF THE PROCEDURE. A SECOND CATHETER WAS USED. UPON REMOVAL OF THE CATHETER FROM THE PATIENT, A VISIBLE CHARRED VEIN AND COAGULATION ON THE HEATING ELEMENT WERE OBSERVED, ALONG WITH COIL DAMAGE CHARACTERIZED BY BURNT RESIDUE AND COAGULANT BUILD-UP ON THE HEATING ELEMENT. THE LUMEN WAS FLUSHED PRIOR TO USE, TUMESCENT INFILTRATION AND GENERAL ANESTHESIA WERE UTILIZED, AND COMPRESSION WITH A TRANSDUCER WAS APPLIED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO ERROR MESSAGES WERE DISPLAYED ON THE GENERATOR, AND THE DEVICES WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW DEVICE AND THE VEIN WAS CLOSED. NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DIFFICULTY IN REMOVING THE CATHETER WAS CONFIRMED FOR THE FIRST CATHETER A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673490 ↗
• MalfunctionMar 19, 2026Electrical /Electronic Property Problem; Overheating of Device; Output Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT VENOUS INSUFFICIENCY OF THE GREAT SAPHENOUS VEIN (GSV) USING THE CATHETER CF6-8-60 CLOSUREFAST, AN ERROR MESSAGE APPEARED AFTER FIVE SECONDS OF THE PROCEDURE AND THE PROPER TEMPERATURE WAS NOT REACHED. "TREATMENT HALTED: TEMPERATURE HIGH" AND "TREATMENT HALTED: DEVICE BROKEN" ALSO DISPLAYED ON THE GENERATOR. TUMESCENT INFILTRATION AND GENERAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. FOUR SEGMENTS OF THE GSV WERE TREATED. TROUBLESHOOTING STEPS INCLUDED RE-CONNECTING THE CATHETER AND RESTARTING THE RFA MACHINE, BUT THE ERROR MESSAGE PERSISTED. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITH ANOTHER ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637222 ↗
• MalfunctionMar 11, 2026Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT THE CLOSUREFAST CATHETER CF6-8-60 EXHIBITED INTERMITTENT FUNCTION AND DISPLAYED AN ERROR MESSAGE INDICATING "CA THETER BROKEN" AFTER BEING USED SUCCESSFULLY FOR TWO TREATMENTS. THE LUMEN WAS FLUSHED PRIOR TO USE, TUMESCENT INFILTRATION AND HAND/MANUAL COMPRESSION WERE UTILIZED, AND NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE VEIN WAS TREATED IN FULL WITH PROPER TEMPERATURE REACHED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT CATHETER OF THE SAME MODEL, AND THE VEIN CLOSED SUCCESSFULLY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INVOLVED. WHEN THE DEVICE WAS RETUNED IT WAS NOTED THAT THE DEVICE WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574606 ↗
• InjuryFeb 16, 2026Overheating of Device; Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE CLOSUREFAST CATHETER CF6-8-60, A HIGH TEMPERATURE WAS OBSERVED, RAISING CONCERNS ABOUT A POTENTIAL BURN AT THE PROXIMAL LEFT SHORT SAPHENOUS VEIN IN SOFT TISSUE. THE DEGREE OF TORTUOSITY WAS MINIMAL, AND THE VEIN DIAMETER WAS 19 MILLIMETERS. TUMESCENT INFILTRATION WAS UTILIZED, THE LUMEN WAS FLUSHED PRIOR TO USE, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO ANESTHESIA OR COMPRESSION WAS USED, AND NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE GENERATOR DID NOT REACH PROPER TEMPERATURE, AND NO ERROR MESSAGES WERE DISPLAYED. THE RFG WAS POWER-CYCLED, BUT THIS DID NOT RESOLVE THE ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE, RESULTING IN VEIN CLOSURE. A FOLLOW-UP ULTRASOUND WAS PLANNED TO DETERMINE IF A BURN OCCURRED. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 24343477 ↗
• MalfunctionJan 29, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A VEIN CLOSURE PROCEDURE USING THE CLOSUREFAST CATHETER, A HIGH TEMPERATURE ISSUE WAS IDENTIFIED WITH THE DEVICE. THE LUMEN WAS FLUSHED PRIOR TO USE, TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND/MANUAL COMPRESSION WAS APPLIED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO DAMAGE WAS NOTED TO THE PACKAGING OR DURING DEVICE REMOVAL FROM THE TRAY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE VEIN WAS SUCCESSFULLY CLOSED USING A NEW DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209065 ↗
• MalfunctionJan 29, 2026Overheating of Device; Material Deformation

  IT WAS REPORTED THAT AFTER USE OF THE CATHETER CF6-8-60 CLOSUREFAST DURING A PROCEDURE TO TREAT VENOUS INSUFFICIENCY, BUBBLING OF THE PROBE COATING WAS OBSERVED AFTER USE IN ONE VEIN. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION AND COMPRESSION WERE UTILIZED DURING THE PROCEDURE, AND THE VEIN WAS CONFIRMED TO BE CLOSED. THE SHEATH USED WAS REPORTED TO BE FINE. A REPLACEMENT CLOSUREFAST CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208044 ↗
• MalfunctionJan 23, 2026Overheating of Device; Connection Problem

  IT WAS REPORTED THAT A PATIENT WITH LOWER EXTREMITY VENOUS INSUFFICIENCY UNDERWENT A PROCEDURE TO TREAT THE GREAT SAPHENOUS VEIN USING THE CLOSUREFAST CATHETER. DURING THE PROCEDURE, THE CATHETER CONNECTION AREA MELTED, BENT, AND BECAME ADHERED, RESULTING IN CATHETER CONNECTION AND PIN DAMAGE, AS WELL AS BENT PINS. THERE WAS DIFFICULTY CONNECTING OR REMOVING THE CATHETER CONNECTOR, AND EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE CATHETER FROM THE GENERATOR. THE VEIN DID NOT CLOSE. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITH A NEW ONE, AND TWO TREATMENT SEGMENTS WERE ADDRESSED. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. THE INSTRUCTIONS FOR USE WERE FOLLOWED, THE LUMEN WAS FLUSHED PRIOR TO USE, AND THE PROPER TEMPERATURE WAS REACHED. NO ERROR CODES OR WARNINGS WERE REPORTED FROM THE GENERATOR, AND ALL PINS REMAINED ON THE CONNECTOR. THE PATIENT REMAINED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION 2026-JAN-21: THE RED MARK WAS ALIGNED WHEN THE CONNECTOR WAS INSERTED INTO THE GENERATOR. COMPRESSION WAS NOT BEING APPLIED WHEN THE ISSUE OCCURRED AND NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160997 ↗
• MalfunctionJan 23, 2026Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING TREATMENT FOR VENOUS INSUFFICIENCY OF THE GREAT SAPHENOUS VEIN USING THE CLOSUREFAST CATHETER, A BENT CATHETER WAS OBSERVED. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA WITH TUMESCENT INFILTRATION. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. AT THE TIME OF THE EVENT THIS DEVICE HAD PASSED ITS USE-BY-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160959 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CLOSUREFAST CATHETER. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PHYSICIAN HAS BEEN DOING VEIN ABLATIONS SINCE 2007; ABOUT 11,000 TOTAL. HE WAS USING VENCLOSE, HOWEVER, THERE WAS A RECALL, AND HE SWITCHED TO USING BOTH EVLA AND RFA (ANGIODYNAMICS AND MEDTRONIC). THE FIRST BATCH OF 75 RFA DID NOT HAVE INFECTION. PHYSICIAN USED ABOUT 32 CATHETERS OF THE SECOND BATCH OF 75 AND STATED 9 BECAME INFECTED. SAME STAFF, SAME SETUP, SAME TUMESCENT. MANY RFAS THAT BECAME INFECTED WERE DONE ON THE SAME DAY AS EVLA. CULTURES WERE ALL NEGATIVE, WHICH PHYSICIAN ATTRIBUTES TO PATIENT BEING ON ANTIBIOTICS PRIOR TO CULTURE BEING TAKEN. NO SEPSIS OR POSITIVE BLOOD CULTURES. THE PHYSICIAN HAS BEEN KEEPING PATIENT ON ORAL ANTIBIOTICS LONG TERM UNTIL COMPLETELY RESOLVED. THE PATIENT DID NOT HAVE A WOUND PRE-OP PRIOR TO INFECTION. THE PHYSICIAN DOES NOT HAVE A PHLEBECTOMY. PHYSICIAN MIXES TUMESCENT ON SITE. THE PATIENT DEVELOPED AN ABSCESS THAT REQUIRED AT LEAST ONE INCISION AND DRAINAGE OF PUS ALONG THE TREATED VEIN. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 24109226 ↗
• MalfunctionNov 17, 2025Overheating of Device; Device Displays Incorrect Message; Output Problem; Overheating of Device; Device Displays Incorrect Message; Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CLOSUREFAST CATHETER, TORTUOSITY WAS OBSERVED IN THE MID-GREAT SAPHENOUS VEIN (GSV), WHICH WAS DESCRIBED AS MINIMAL. THE CATHETER WAS REPORTED TO HAVE MALFUNCTIONED DURING USE IN THE PATIENT, WITH COIL DAMAGE AND BURNT RESIDUE NOTED ON THE HEATING ELEMENT. TEMPERATURE INCONSISTENCIES WERE OBSERVED, AND ERROR MESSAGES INDICATING LOW TEMPERATURE, HIGH POWER, AND AN ADJUST COMPRESSION WARNING WERE DISPLAYED. MINIMAL RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND HAND/MANUAL COMPRESSION WAS UTILIZED. LOCAL ANESTHESIA AND TUMESCENT INFILTRATION WERE USED. THE LUMEN WAS FLUSHED PRIOR TO USE, AND NO GUIDEWIRE WAS USED FOR CATHETER INSERTION. THE INSTRUCTIONS FOR USE WERE FOLLOWED, THOUGH ISSUES WERE NOTED WITH THE CATHETER. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS CONTINUED WITH THE MALFUNCTIONING DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567732 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CLOSUREFAST CATHETER. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Abscess; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 23509588 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CLOSUREFAST CATHETER. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Abscess; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 23509540 ↗
• MalfunctionOct 31, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT DURING TREATMENT OF A LESION IN THE RIGHT DISTAL GREAT SAPHENOUS VEIN WITH THE CLOSUREFAST CATHETER, THE CATHETER WAS NOT RESPONDING OR RECOGNIZED, AND AN ERROR MESSAGE WAS DISPLAYED STATING - THE CONNECTED DEVICE IS NOT SUPPORTED. PLEASE CONNECT ANOTHER DEVICE. THE RFG WAS POWER-CYCLED, BUT THE ERROR REMAINED. A SECOND CATHETER WAS ATTEMPTED WITH THE SAME RFG AND WAS SUCCESSFUL. FOUR SEGMENTS WERE TREATED, AND THE VEIN CLOSED SUCCESSFULLY USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR ANALYSIS IT WAS NOTED THAT THE COIL WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436386 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CATHETER CF6-8-60 CLOSUREFAST AN MIS-6F07 MICRO INTRODUCER KIT. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 23051537 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CATHETER CF6-8-60 CLOSUREFAST AN MIS-6F07 MICRO INTRODUCER KIT. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 23051404 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CATHETER CF6-8-60 CLOSURE FAST <(>&<)> AN MIS-6F07 MICRO INTRODUCER KIT. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 23051314 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CATHETER CF6-8-60 CLOSUREFAST & AN MIS-6F07 MICRO INTRODUCER KIT. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Unspecified Infection

  MAUDE report 23051250 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CATHETER CF6-8-60 CLOSUREFAST & AN MIS-6F07 MICRO INTRODUCER KIT. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Unspecified Infection

  MAUDE report 23051179 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION FOLLOWING A PROCEDURE INVOLVING THE CATHETER CF6-8-60 CLOSUREFAST & AN M IS-6F07 MICRO INTRODUCER KIT. THE INFECTION WAS ASSOCIATED WITH PAIN AND PUS. THE INFECTION OCCURRED ALONG THE TREATED GREAT SAPHENOUS VEIN (>5CM FROM ACCESS SITE) IN THE MID SEGMENT. THIS WAS AN INITIAL EVENT. THERE ARE NO KNOWN PATIENT ALLERGIES. MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE AFFECTED PATIENT REQUIRED HOSPITALIZATION. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 23050968 ↗