ClosureFast™ CF7-7-100 (UDI 00643169862982)Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00643169862982), received between Jun 21, 2018 and Feb 12, 2025 — classified as 23 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Overheating of Device; Difficult to Remove; Detachment of Device or Device Component; Overheating of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR VENOUS INSUFFICIENCY USING THE CF7-7-100 CLOSUREFAST 7F 100 CM CATHETER, THERE WAS A NOISE LIKE WATER BOILING, AND THE COIL MELTED. THERE WERE ISSUES WITH CATHETER WITHDRAWAL. TUMESCENT INFILTRATION AND HAND COMPRESSION WERE UTILIZED, AND THE VEIN CLOSED. IT WAS REPORTED THAT THE TRANSPARENT COATING LEFT THE CATHETER COIL AND COULD STILL BE IN THE PATIENT. THE DOCTOR CHECKED THE PATIENT AFTER THE PROCEDURE AND EVERYTHING WAS GOOD. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362616 ↗
• MalfunctionDec 12, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSUREFAST CATHETER TO TREAT A LESION IN THE GREAT SAPHENOUS VEIN (GSV). TUMESCENT INFILTRATION WAS UTILIZED. GENERAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. LUMEN WAS FLUSHED PRIOR TO USE. A RADIO FREQUENCY GENERATOR WAS USED. CATHETER TEMPERATURE THERMOCOUPLE OCCURRED. COIL MELTED. 6 CYCLES WERE DELIVERED. A NEW CATHETER WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912116 ↗
• MalfunctionNov 26, 2024Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT VENOUS INSUFFICIENCY IN THE ANTERIOR LATERAL ACCESSORY VEIN USING A CLOSUREFAST CATHETER, THE HEATING ELEMENT BROKE DURING TRIGGERING, LEAVING AN APPROXIMATELY A 4 CM LONG PART STUCK IN THE VEIN AND REMAINING IN THE PATIENT. A CATHETER KINK WAS OBSERVED DURING INSERTION INTO THE PATIENT, SPECIFICALLY ON THE COIL. THE PROCEDURE WAS NOT COMPLETED. TUMESCENT INFILTRATION WAS UTILIZED, AND LOCAL ANESTHESIA WAS USED. NO GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. 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 20787017 ↗
• MalfunctionNov 6, 2024Overheating of Device; Deformation Due to Compressive Stress; Overheating of Device; Deformation Due to Compressive Stress

  A PHYSICIAN WAS ATTEMPTING TO USE A CLOSURE FAST RFA CATHETER FOR TREATMENT. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE CATHETER WAS KINKED IN THE MIDDLE WHEN THE CUSTOMER OPENED THE BOX. THE DEVICE WAS USED IN THE PATIENT. NO PATIENT INJURY REPORTED. WHEN THE DEVICE RETURNED TO MEDTRONIC FOR EVALUATION IT WAS NOTED TO HAVE BURN MARKS AND THE COIL WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618643 ↗
• MalfunctionOct 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSUREFAST CATHETER TO TREAT A LESION. THE TIP WAS MELTED. A NEW CATHETER WAS USED AND THE TREATMENT WAS FINALIZED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471012 ↗
• MalfunctionOct 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSUREFAST CATHETER TO TREAT A LESION. THE TIP WAS MELTED. A NEW CATHETER WAS USED AND THE TREATMENT WAS FINALIZED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470957 ↗
• MalfunctionSep 23, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS RIGHT GREAT SAPHENOUS VEIN (GSV). THE IFU (INSTRUCTIONS FOR USE) WAS FOLLOWED DURING PREPARATION, THE PROCEDURE, AND POST-PROCEDURE. THE PATIENT WAS SUPINE UNDER VENTILATORY ANESTHESIA, ANTISEPSIS AND STERILE DRAPES WERE PLACED. THE RIGHT GSV WAS PUNCTURED IN THE PROXIMAL LEG UNDER ULTRASOUND GUIDANCE, THE GUIDEWIRE WAS PASSED AND THEN THE 7F 11CM INTRODUCER WAS PERFORMED WITHOUT PROBLEMS, AND ADEQUATE VENOUS REFLUX WAS OBSERVED THROUGH IT. IT WAS REPORTED THAT WHEN INTRODUCING THE CLOSUREFAST CATHETER, APPROXIMATELY 20 CM IN, THE DEVICE BROKE NEAR THE INTRODUCER SHEATH, CAUSING THE PLASTIC PROTECTION SURROUNDING THE METAL CORE OF THE CATHETER TO RUPTURE. THE BREAKAGE OCCURRED IN THE FIRST MOVEMENTS, EVEN BEFORE THE FIRST ACTIVATION OF THE CATHETER. PHYSICIAN IS FAMILIAR WITH THE CATHETER AND ITS MANIPULATION; THIS SPECIFIC CATHETER HAD A BRITTLE STRUCTURE. AFTER REMOVING THE CATHETER, OTHER POINTS OF BREAKAGE WERE OBSERVED. THE PROCEDURE WAS HALTED DUE TO CONCERNS ABOUT A COMPLETE SEPARATION OF THE CATHETER PARTS INSIDE THE PATIENT AND THE RISK OF EMBOLIZATION. THE CATHETER WAS SAFELY REMOVED FROM THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278417 ↗
• MalfunctionAug 21, 2024Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  A CLOSUREFAST CATHETER WAS INTENDED TO BE USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). LOCAL ANAESTHESIA, HAND COMPRESSION AND TUMESCENT INFILTRATION WAS USED. THE IFU WAS FOLLOWED. IT WAS NOTED THAT THE DEVICE WAS USED POST EXPIRY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014659 ↗
• MalfunctionJun 4, 2024Overheating of Device; Deformation Due to Compressive Stress; Material Deformation; Overheating of Device; Deformation Due to Compressive Stress; Material Deformation

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER FOR TREATMENT. THE LUMEN WAS FLUSHED PRIOR TO USE. TUMESCENT INFILTRATION, GENERAL  ANESTHESIA AND HAND/MANUAL COMPRESSION WAS USED. THERE WAS NO DAMAGE TO PACKAGING. THE PROPER TEMPERATURE WAS REACHED. 6 SEGMENTS WERE TREATED. IT WAS REPORTED A KINK WAS NOTED AND THE CATHETER HAD UNRAVELED. THE ISSUE WAS NOTED DURING THE PROCEDURE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459413 ↗
• MalfunctionMay 17, 2024Overheating of Device; Deformation Due to Compressive Stress; Material Deformation; Overheating of Device; Deformation Due to Compressive Stress; Material Deformation

  A CLOSUREFAST RFA CATHETER WAS BEING USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). 5 RF CYCLES WERE CARRIED OUT, TRANSDUCER COMPRESSION WAS USED AND TUMESCENT INFILTRATION. THE LUMEN WAS FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED. IT WAS REPORTED UPON REM OVAL/WITHDRAWAL THAT A KINK WAS NOTED ON THE COIL. NO PART OF THE COIL WAS EXPOSED. NO ERROR MESSAGES/CODES/WARNINGS WERE DISPLAYED. THERE WERE  TWO ACCESS POINTS DUE TO A TORTUOUS SECTION SO WHEN THE KINK WAS NOTICED ANOTHER CATHETER WAS USED TO COMPLETE THE PROC EDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340770 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER DURING TREATMENT OF PATIENTS GREAT SAPHENOUS VEIN (GSV). 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 UTILIZED. HAND COMPRESSION WAS UTILIZED. PROCEDURE WAS COMPLETED PER IFU AND THE PATIENT WENT HOME WITHOUT COMPLAINTS. IT WAS REPORTED A DAY AFTER PROCEDURE, PATIENT EXPERIENCED PAIN WHEN WALKING AND AN IRRITATION/BURNING SENSATION NEAR THE ACCESS POINT. THE PATIENT DID NOT COMPLAIN OF PAIN DURING ACTIVE TREATMENT. THERE WERE NO OTHER DEVICES UTILIZED. THE IRRITATION/BURN IS BEING TREATED WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). THE IRRITATION/BURN IS STILL PRESENT.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 19032033 ↗
• MalfunctionMar 12, 2024Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation; Output Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation; Output Problem

  A CLOSUREFAST CATHETER WAS BEING USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FLUSHED. THE IFU WAS FOLLOWED. TU MESCENT FLUID AND COMPRESSION WERE USED. IT WAS REPORTED THE TEMPERATURE OF THE DEVICE WOULD NOT RISE TO 120 DEGREES, , IT HAS BEEN TRIED REPEATEDLY UP TO 22 RF CYCLES BUT IT REMAINS THE SAME. IN 1 SEGMENT THAT HAD BEEN BURNED, THE DOCTOR EVALUATED IT USING ULTRASOUND, THE GSV IN THAT SEGMENT WAS NOT CLOSED. TREATMENT WAS CARRIED OUT REPEATEDLY WITH THE ADDITION OF TUMESCENT AND COMPRESSION BUT THE TEMPERATURE DID NOT REACH 120 DEGREES SO IT WAS REPLACED WITH A NEW CLOSUREFAST CATHETER WITH BATCH/LOT: 231210145. AFTER BEING REPLACED, THE TEMPERATURE IMMEDIATELY ROSE AND SUCCEEDED IN BURNING THE GSV UNTIL IT CLOSED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884338 ↗
• MalfunctionFeb 25, 2024Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER DURING PATIENT TREATMENT. THE LUMEN WAS NOT FLUSHED PRIOR TO USE. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION WAS UTILIZED. TRANSDUCER COMPRESSION WAS USED. IT WAS REPORTED THE CATHETER WAS UNABLE TO REACH TARGET TEMPERATURE. A SECOND CATHETER WAS USED TO COMPLETE PROCEDURE BUT WHEN SECOND CATHETER WAS REMOVED FROM PATIENT, IT APPEARED THAT THE HEATING ELEMENT WAS FALLING APART. THE COIL APPEARED TO BE PARTIALLY MELTED, AS WELL AS HAVING EXCESSIVE COAGULANT BUILDUP. UNKNOWN IF COIL WAS EXPOSED. 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 18774839 ↗
• MalfunctionJan 3, 2024Overheating of Device; Output Problem; Overheating of Device; Output Problem

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER DURING PATIENT TREATMENT OF THE GSV, SSV. THE IFU WAS FOLLOWED. THE LUMEN WAS FLUSHED PRIOR TO USE. COMPRESSION WAS USED. PROPER TEMPERATURE WAS NOT REACHED. IT IS REPORTED THE CLOSUREFAST CATHETER WAS CONNECTED TO THE GENERATOR THEN INSERTED IN THE PATIENT AND REACHED TARGET AREA WELL. UPON STARTING THE 1ST RF ABLATION CYCLE THE HEATING ELEMENT FAILED TO ACHIEVE 120°C BUT INSTEAD STOPPED AT 105°C WITH THE W READING 22. THE SECOND RF CYCLE STILL DID NOT ACHIEVE 120°CBUT REACHED 112°C WITH W READING 23. AS PHYSICIAN TRIED TO WITHDRAW THE CLOSUREFAST CATHETER HE EXPERIENCED SOME RESISTANCE HOWEVER MANAGED TO WITHDRAW IT. UPON INSPECTION OF THE HEATING ELEMENT, THERE WAS SOME PILING AT THE HEATING ELEMENT. 1 AREA WAS TREATED. THE VEIN DID CLOSE AFTER USING A SECOND CATHETER ON THE SAME GENERATOR. EXPERIENCING SWELLING AND PAIN AT THE LEFT UPPER THIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433471 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLOSUREFAST CATHETER WAS USED WITH AN RFG3 FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (B)(6) 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 18356794 ↗
• InjuryDec 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CLOSUREFAST CATHETER WAS BEING USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). TUMESCENT INFILTRATION, LOCAL ANESTHESIA AND  TRANSDUCER COMPRESSION WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED AT THE BEGINNING THE GENERATOR SHOWED UNREALISTIC NUMBERS (THE WATT NUMBERS ON THE GENERATOR JUMPING UP AND DOWN (EXTREMELY LOW AND THAN EXTREMELY HIGH). THE GENERATOR HAS BEEN USED SUCCESSFULLY SINCE. 23 CYCLES WERE PERFORMED AND THE VEIN CLOSED. ON THE (B)(6) 2023 EHIT GRADE 3 WAS IDENTIFIED IN THE ULTRASOUND. PATIENT PRESCRIBED XARELTO.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18356740 ↗
• MalfunctionDec 19, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSUREFAST CATHETER TO TREAT A LESION IN THE GREAT SAPHENOUS VEIN (GSV). A RFG3 WAS USED. IFU WAS FOLLOWED. THE CATHETER MELTED, DUE TO THIS THE PROCEDURE TOOK EXTRA TIME BUT THE PATIENT IS DOING WELL. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE COIL WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354088 ↗
• MalfunctionDec 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  PHSICIAN 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. TUMESCENT INFILTRATION WAS UTILIZED. LOCAL ANESTHESIA WAS USED. COLD PRESS COMPRESSION WAS USED. PROPER TEMPERATURE WAS REACHED. IT IS REPORTED DURING THE PROCEDURE, IT FELT LIKE THE CATHETER WAS STICKING TO THE TISSUE. AFTER THE SECOND SEGMENT, THE CATHETER WAS REMOVED AND A CATHETER WAS NOT REINSERTED. THE PROCEDURE WAS NOT COMPLETED, THEREFORE THE PATIENT WILL COME FOR A CHECK-UP IN 15 DAYS. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUTION, IT WAS NOTED THAT THE CATHETER WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343530 ↗
• MalfunctionOct 9, 2023Overheating of Device; Activation, Positioning or Separation Problem; Output Problem; Overheating of Device; Activation, Positioning or Separation Problem; Output Problem

  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. THERE WAS NO CALCIFIC OR TORTUOUS ANATOMY. TUMESCENT INFILTRATION WAS UTILIZED AND SPINAL ANESTHESIA WAS USED. HAND COMPRESSION WAS USED. IT IS REPORTED THE CATHETER DIDN'T REACH PROPER TEMPERATURE. THE PHYSICIAN ATTEMPTED SEVERAL TIMES OF ABLATION WITH ADEQUATE AMOUNT OF TUMESCENT AND COMPRESSION. AFTER PHYSICIAN EVALUATED IT WITH ULTRASONOGRAPHY (USG) THE VEIN WASN¿T OCCLUDED AND THEY CHANGED THE CATHETER WITH A NEW ONE TO REDO THE PROCEDURE FROM THE START. THERE WERE NO ISSUES WITH INSERTION OR WITHDRAWAL. WHEN CATHETER WAS WITHDRAWN FROM PATIENT BURNT RESIDUE WAS OBSERVED ON CATHETER, THERE WAS NO COIL EXPOSED. ERROR MESSAGE DISPLAYED ON THE GENERATOR ¿ADVISORY: LOW TEMPE RATURE, HIGH POWER, ADJUST COMPRESSION¿. 1 SEGMENT WAS TREATED AND THE VEIN IS REPORTED TO HAVE CLOSED SUCCESSFULLY. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE COIL WAS EXPOSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894149 ↗
• InjurySep 27, 2023Output Problem; Output Problem

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). 1 SEGMENT WAS TREATED. HAND COMPRESSION AND TUMESCENT INFILTRATION WAS USED. THE IFU WAS FOLLOWED. THE LUMEN WAS FLUSHED PRIOR TO USE. 3 CYCLES WERE DELIVERED. CATHETER TEMPERATURE ISSUES WERE ENCOUNTERED. IT WAS REPORTED ADDITIONAL TUMESCENT FLUID AND COMPRESSION BUT THE DEVICE TEMPERATURE WOULD NOT INCREASE TO 120 DEGREE. EACH SEGMENT WAS TREATED WITH 3 TIMES BUT THE TEMPERATURE STILL WOULDN'T INCREASE AND WHEN THE PHYSICIAN EVALUATED THE VESSEL WITH USG, THE GSV WAS NOT CLOSED. THE AMOUNT OF TUMESCENT AND COMPRESSION HAS BEEN ADDED BUT THE TEMPERATURE WAS STILL NOT INCREASING AND THE PHYSICIAN DECIDED TO DO MANUAL STRIPPING TO TREAT THE GSV. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17824974 ↗
• MalfunctionAug 31, 2023Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  A CLOSUREFAST CATHETER WAS REPORTED TO HAVE A TEMPERATURE THERMOCOUPLE ISSUE WITH LITTLE INFORMATION.  IT WAS REPORTED THE TEMPERATURE WASN¿T READING PROPERLY ON THE GENERATOR. IT IS NOTED THAT THE CATHETER HAD EXPIRED AT THE TIME OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666539 ↗
• MalfunctionJul 24, 2023Obstruction of Flow; Detachment of Device or Device Component; Material Deformation; Obstruction of Flow; Detachment of Device or Device Component; Material Deformation

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FOLLOWED. IT WAS REPORTED THE  PHYSICIAN USED GUIDEWIRE IN BOTH LEGS. FIRST LEG WAS DONE WITHOUT ANY ISSUE. AND THE PHYSICIAN TRIED TO USE GUIDEWIRE IN SECOND LEG PROCEDURE, BUT THE CATHETER LUMEN WAS OCCLUDED. WHEN HE TRIED TO PUSH THE GUIDEWIRE, HE FELT RESISTANCE. WHEN HE TOOK OUT RF CATHETER FROM PATIENT'S LEG, THE CATHETER TIP WAS DAMAGED. ANOTHER RFA CATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378618 ↗
• InjuryApr 25, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CLOSUREFAST RFA CATHETER WAS INTENDED TO BE USED. IFU WAS FOLLOWED. THE DEVICE DISPLAYED AN ERROR MESSAGE "BROKEN CATHETER". THE ISSUE WAS NOTED DURING THE PROCEDURE. THE RFG WAS RE-BOOTED BUT THE SAME ERROR MESSAGE APPEARED. THE CATHETER WAS NOT REPLACED. THE PROCEDURE WAS NOT COMPLETED AS INTENDED, PARTIAL THERMAL ABLATION OF 'LAVSI'. THE PROCEDURE WAS COMPLETED WITH VEIN STRIPPING OR OTHER HIGH LIGATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805928 ↗
• MalfunctionMar 31, 2023Overheating of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Impedance Problem; Overheating of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Impedance Problem

  A PHYSICIAN WAS USING A CLOSUREFAST RFA CATHETER FOR THE TREATMENT OF 1 SEGMENT OF THE GREAT SAPHENOUS VEIN (GSV). COMPRESSION WAS USED. THE VEIN DID NOT CLOSE. THE LUMEN WAS FLUSHED PRIOR TO USE. AN RFG3 WAS USED. THE IFU WAS FOLLOWED. THE APPROPRIATE TEMPERATURE WAS REACHED. IT WAS REPORTED DURING THE ROUTINE ABLATION THE CLOSUREFAST CATHETER APPEARED TO MELT IN SITU AND BECAME STUCK. IT WAS ALSO NOTICED THAT THERE WERE HIGH IMPEDANCE READINGS ON SCREEN OF GENERATOR AT THE SAME TIME. THE PHYSICIAN WAS ABLE TO EVENTUALLY REMOVE THE FAULTY CATHETER AND CONTINUE TREATMENT WITH ANOTHER. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657462 ↗
• MalfunctionFeb 20, 2023Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT DURING A PROCEDURE TO TREAT THE GREAT SAPHENOUS VEIN (GSV) A EXPIRED CLOSUREFAST CATHETER WAS USED. PROPER TEMPERATURE WAS REACHED. 4 SEGMENTS WERE TREATED AND THE VEIN CLOSED. NO ADDITIONAL TREATMENT REQUIRED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404013 ↗

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