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ClosureFast™ CF7-7-100 (UDI 00763000702274)Recalls & reported problems

Medtronic, Inc. · CATHETER CF7-7-100 CLOSURE FAST V05 · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Medtronic ClosureFast catheter is used to treat veins with heat. Reports mostly describe overheating, connection or temperature problems, and parts deforming or breaking; there are 24 reports, no deaths, and 1 injury. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
24
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000702274), received between Feb 6, 2025 and Aug 26, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (17 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 3 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 4 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 2 reportsFeb 2026: 2 reportsMar 2026: 1 reportsApr 2026: 2 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device17
  • Electrical /Electronic Property Problem5
  • Deformation Due to Compressive Stress4
  • Material Deformation4
  • Output Problem4
  • Detachment of Device or Device Component3
  • Difficult to Remove3
  • Fracture2

Patient problems

  • No Clinical Signs, Symptoms or Conditions22
  • Insufficient Information1
  • Pain1

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 26, 2026Electrical /Electronic Property Problem; Detachment of Device or Device Component; Impedance Problem

    A Closurefast catheter was being used to treat the Anterior Accessory Great Saphenous Vein (AAGSV). Tumescent infiltration and local anesthesia were utilized, no compression used.  A guidewire was used for the insertion of the catheter. Proper temperature was not reached and the catheter was not responding/recognized. Error message Impedance high, Check connection was displayed on the RFG3. The generator was power-cycled and the error remained. The catheter was unplugged and re-connected, unit powered off and restarted. Another catheter was used with the same RFG3 to complete the procedure, four segments were treated and vein closed. The lumen was flushed prior to use, the IFU (Instruction for Use) was followed during preparation, procedure, post-procedure. No adjustments were made to the parameters of the generator. The impedance issue occurs consistently upon activation of the catheter. No patient complications have been reported as a result of this event. No adjustments were made to the parameters of the generator. The impedance issue occurs consistently upon activation of the catheter. When the device was returned for evaluation, it was noted that the catheter shaft was separat

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50449793 ↗
  • MalfunctionAug 18, 2026Fracture; Overheating of Device; Difficult to Advance; Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50294671 ↗
  • MalfunctionJul 28, 2026Output Problem; Power Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50051748 ↗
  • MalfunctionMay 7, 2026Overheating of Device; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT DURING A PROCEDURE USING A CLOSUREFAST CATHETER TO TREAT THE GREAT SAPHENOUS VEIN, RESISTANCE WAS FELT WHEN THE PHYSICIAN WAS ABOUT TO REMOVE THE CATHETER, AND WHEN THE CATHETER WAS PULLED OUT AND REMOVED, THE THERMAL ELEMENT WAS OBSERVED TO BE BROKEN AND KINKED WITH THE BARE COIL EXPOSED. TUMESCENT INFILTRATION WAS UTILIZED, LOCAL ANESTHESIA WAS USED, AND HAND COMPRESSION WAS APPLIED. A GUIDEWIRE WAS USED FOR INSERTION, THE LUMEN WAS FLUSHED PRIOR TO USE, PROPER TEMPERATURE WAS REACHED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE. THE PROCEDURE WAS COMPLETED WHEN THE ISSUE OCCURRED. THE VEIN WAS REPORTED TO HAVE CLOSED, AND 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 25111460 ↗
  • MalfunctionApr 13, 2026Overheating of Device

    IT WAS REPORTED THAT, PRIOR TO USE OF THE CLOSUREFAST 7F 100 CM CATHETER, THE PROBE OVERHEATED TO GREATER THAN 175°C AND AN ERROR ME SSAGE STATING - PROBE BROKEN, WAS DISPLAYED. PROPER TEMPERATURE WAS REPORTED AS REACHED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24853693 ↗
  • MalfunctionApr 1, 2026Electrical /Electronic Property Problem; Overheating of Device

    IT WAS REPORTED THAT THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER WAS NOT RESPONDING, WAS NOT RECOGNIZED, AND HAD INADEQUATE CATHETER CONTACT. THE DEVICE WAS NOT REPROCESSED, THE LUMEN WAS NOT FLUSHED PRIOR TO USE, AND A GUIDEWIRE WAS NOT USED FOR INSERTION. PROPER TEMPERATURE WAS NOT REACHED. THE PHYSICIAN COMPLETED THE PROCEDURE BY USING A NEW CATHETER. NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION IT WAS NOTED THAT THE PROBE WAS DETACHED

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24756164 ↗
  • MalfunctionMar 2, 2026Overheating of Device

    IT WAS REPORTED THAT DURING TREATMENT FOR VENOUS INSUFFICIENCY OF THE SHORT SAPHENOUS VEIN (SSV) USING THE CLOSUREFAST 7F 100 CM CATHETER, THE CATHETER COVER WAS BURNT. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. LOCAL ANESTHESIA WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CLOSUREFAST CATHETER, AND THE VEIN CLOSED SUCCESSFULLY. 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 24482300 ↗
  • MalfunctionFeb 9, 2026Overheating of Device

    IT WAS REPORTED THAT SCORCH MARKS WERE OBSERVED ON THE HEATING COIL OF THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER AFTER TREATMENT OF ONE LEG. A GUIDEWIRE WAS USED FOR INSERTION. PROPER TEMPERATURE WAS REACHED DURING THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE USING A NEW CATHETER. THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290866 ↗
  • MalfunctionFeb 8, 2026Overheating of Device; Deformation Due to Compressive Stress; Output Problem

    IT WAS REPORTED ONCE THE CLOSUREFAST PACKAGING WAS OPENED, UPON INSPECTION/INSERTION IT WAS NOTED THAT THE CATHETER HAD A KINK APPRO XIMATELY 7-8CM FROM THE TIP. IN ADDITION, THE DEVICE EXHIBITED DELAYED HEATING FREQUENCY AND ACTIVATION DURING TESTING ON THE TABLE. THE DEFECT WAS PRESENT OUT OF PACKAGE AND WAS NOT USED FOR THE PROCEDURE LEADING TO INTRAOPERATIVE DELAY. LASER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE CATHETER WAS DAMAGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24288219 ↗
  • InjuryJan 19, 2026Detachment of Device or Device Component; Impedance Problem; Output Problem

    IT WAS REPORTED THAT DURING TREATMENT FOR VENOUS INSUFFICIENCY OF THE GREAT SAPHENOUS VEIN USING THE CLOSUREFAST CATHETER, THE DEVICE DISPLAYED AN IMPEDANCE DISRUPTION READING AND A MALFUNCTION OF THE OPERATING TEMPERATURE AT 85°C, AFTER WHICH IT CEASED TO FUNCTION. THE DISTAL HALF OF THE ACTIVE HEATING ZONE OF THE CATHETER REMAINED INTRAVASCULAR, RESULTING IN A RETAINED CATHETER FRAGMENT IN THE VEIN. SURGICAL REMOVAL OF THE DAMAGED CATHETER COMPONENT WAS REQUIRED. THE VEIN DID NOT CLOSE. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. THE PATIENT WAS ALIVE WITH INJURY FOLLOWING THE EVENT.

    Patient problems: Insufficient Information

    MAUDE report 24108797 ↗
  • MalfunctionJan 16, 2026Electrical /Electronic Property Problem; Overheating of Device; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT CHRONIC VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN USING THE CLOSUREFAST RADIOFREQUENCY (RF) CATHETER, RESISTANCE WAS FELT DURING CATHETER REMOVAL AND THE GENERATOR INDICATED A DEVICE MALFUNCTION. IT IS NOT KNOWN WHAT ERROR MESSAGE WAS DISPLAYED ON THE RFG. THE HEATING PART OF THE CATHETER WAS DAMAGED WHEN FORCE WAS APPLIED TO REMOVE IT. THE COIL WAS EXPOSED. THE CATHETER WAS REPLACED TO COMPLETE THE PROCEDURE. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS USED. THE VEIN CLOSED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24094144 ↗
  • MalfunctionDec 1, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

    IT WAS REPORTED THAT DURING TREATMENT OF VENOUS INSUFFICIENCY WITH THE CLOSUREFAST 7F 100CM CATHETER, THE CATHETER WAS NOT RESPONDING OR RECOGNIZED, AND A DEFECTIVE CATHETER WAS INDICATED. ANOTHER CATHETER WAS USED WITH THE SAME GENERATOR. THE PATIENT REMAINED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23680489 ↗
  • MalfunctionNov 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT DURING PREPARATION OF THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER, A KINK WAS OBSERVED ON THE COIL. THE KINK WAS IDENTIFIED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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 23567430 ↗
  • MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING USE OF THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER, THE COIL BURNED AND HIGH TEMPERATURE WAS OBSERVED. THIS ISSUE WAS NOTED FOR 4 CATHETERS. A REPLACEMENT CATHETER WAS USED 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 23276798 ↗
  • MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING USE OF THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER, THE COIL BURNED AND HIGH TEMPERATURE WAS OBSERVED. THIS ISSUE WAS NOTED FOR 4 CATHETERS. A REPLACEMENT CATHETER WAS USED 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 23276748 ↗
  • MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING USE OF THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER, THE COIL BURNED AND HIGH TEMPERATURE WAS OBSERVED. THIS ISSUE WAS NOTED FOR 4 CATHETERS. A REPLACEMENT CATHETER WAS USED 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 23276720 ↗
  • MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING USE OF THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER, THE COIL BURNED AND HIGH TEMPERATURE WAS OBSERVED. THIS ISSUE WAS NOTED FOR 4 CATHETERS. A REPLACEMENT CATHETER WAS USED 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 23276719 ↗
  • MalfunctionAug 19, 2025Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN USING THE CLOSUREFAST 7F 100CM CATHETER, THE DEVICE REMAINED STUCK TO THE VEIN, PREVENTING NORMAL REMOVAL. GREATER FORCE WAS REQUIRED TO REMOVE THE DEVICE. A MELTED COIL BURNT RESIDUE OBSERVED ON THE CATHETER WERE ALSO REPORTED. THE CONSOLE DISPLAYED A DEVICE-RELATED ERROR. TUMESCENT INFILTRATION WAS UTILIZED, AND TWO CYCLES WERE DELIVERED. A REPLACEMENT CLOSUREFAST CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE VEIN CLOSED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22837909 ↗
  • MalfunctionJul 4, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

    IT WAS REPORTED THAT THE CF7-7-100 CLOSUREFAST 7F 100CM CATHETER EXPERIENCED ISSUES WITH RECOGNITION DURING USE. THE CATHETER WAS NOT RESPONDING OR RECOGNIZED, AND THERE WAS POOR RECOGNITION REPORTED. THE RFG WAS NOT POWER-CYCLED. THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE. A GUIDEWIRE WAS NOT USED FOR THE INSERTION OF THE CATHETER, AND THE LUMEN WAS NOT FLUSHED PRIOR TO USE. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN USING A NEW CATHETER WITH THE SAME RFG, AND NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO PATIENT INVOLVED. 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 22402135 ↗
  • MalfunctionJun 19, 2025Overheating of Device; Deformation Due to Compressive Stress; Overheating of Device; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE LEFT GREAT SAPHENOUS VEIN IN A PATIENT, SEVERAL ISSUES OCCURRED. THE VEIN WAS ACCESSED AT THE PROXIMAL THIGH AROUND 12 CM FROM THE SAPHENOFEMORAL JUNCTION (SFJ), AND THE CLOSUREFAST 7F 100CM CATHETER WAS POSITIONED 2.7 CM FROM THE SFJ. TUMESCENT INFILTRATION, LOCAL ANESTHESIA AND COMPRESSION WERE UTILIZED. DURING THE FIRST TREATMENT LOCATED AT THE #11 ON THE CATHETER, AN ADVISORY MESSAGE OF "LOW TEMPERATURE, HIGH POWER ADJUST COMPRESSION" APPEARED WITH 11 SECONDS LEFT, AND THE TREATMENT WATTAGE DID NOT DROP BELOW 20 WATTS WITHIN THE FIRST 10 SECONDS. ADDITIONAL HAND COMPRESSION WAS APPLIED, AND THE MESSAGE RESOLVED. THE SAME WATTAGE ISSUE OCCURRED DURING THE SECOND TREATMENT. THE TEAM WAS INFORMED, AND A THIRD TREATMENT WAS PERFORMED WITH ULTRASOUND PROBE COMPRESSION AND FINGER COMPRESSION, AFTER WHICH PARAMETERS WERE ESTABLISHED. A FOURTH TREATMENT WAS PERFORMED TO ENSURE ADEQUATE TREATMENT AT THE SAPHENOFEMORAL JUNCTION. SUBSEQUENT TREATMENTS AT THE #7 MARK ON THE CATHETER MET ALL PARAMETERS WITHOUT FURTHER ADVISORY MESSAGES. A LOT OF RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE MICRO INTRODUCER 7F 7CM SHEATH. THE NURSE PRACTIT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22292250 ↗
  • MalfunctionMay 29, 2025Fracture; Material Deformation; Output Problem; Fracture; Material Deformation; Output Problem

    IT WAS REPORTED THAT AFTER TREATMENT OF THE FIRST SEGMENT OF THE GREAT SAPHENOUS VEIN FOR VENOUS INSUFFICIENCY USING THE CLOSUREFAST CATHETER WITH AN RFG3, THE CATHETER BECAME BROKEN. THE CATHETER WAS PLACED AT THE CORRECT LOCATION NEAR THE JUNCTION, AND TREATMENT WAS INITIATED. DURING THE FIRST CYCLE, THE CATHETER STOPPED HEATING, AND THE PHYSICIAN REMOVED THE BROKEN CATHETER. ALL PROCEDURAL STEPS WERE FOLLOWED, INCLUDING THE USE OF TUMESCENT INFILTRATION, LOCAL ANESTHESIA, AND HAND COMPRESSION. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER, AND THE PATIENT DID NOT EXPERIENCE ANY INJURIES OR COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22105737 ↗
  • MalfunctionFeb 24, 2025Material Deformation; Material Deformation

    IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN USING A CF7-7-100 CLOSUREFAST 7F 100CM CATHETER, THE COIL UNRAVELED AND AN ERROR CODE INDICATED THAT THE TEMPERATURE WAS NOT REACHED DUE TO COMPRESSION NOT BEING UNIFORM. NO PART OF THE COIL WAS EXPOSED AND NO COAGULANT BUILD-UP ON THE HEATING ELEMENT. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. THREE SEGMENTS OF THE VEIN WERE TREATED, AND THE VEIN SUCCESSFULLY CLOSED. NO VESSEL DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER, AND NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION IT WAS NOTED THAT THE COIL WAS EXPOSED

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21443914 ↗
  • MalfunctionFeb 13, 2025Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CLOSURE FAST CATHETER, THE PATIENT COMPLAINED OF EXCESSIVE PAIN AT THE TIME OF RADIOFREQUENCY AND THE CATHETER WAS DIFFICULT TO WITHDRAW. AFTER THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS NOT PERFECTLY SMOOTH BUT THERE WAS A BULGE THAT COULD EXPLAIN THE DIFFICULTY IN REMOVING. TUMESCENT INFILTRATION, COMPRESSION AND LOCAL ANESTHESIA WERE UTILIZED. NO PART OF THE COIL WAS EXPOSED. THERE WERE NO ERROR MESSAGES /CODES/WARNINGS DISPLAYED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITHOUT RESISTANCE/INTERVENTION. NO VESSEL DAMAGE REPORTED. NO ADDITIONAL TREATMENT WAS REQUIRED AND THE VEIN IS REPORTED TO HAVE CLOSED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Pain

    MAUDE report 21372232 ↗
  • MalfunctionFeb 6, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT THERE WAS A LABELLING AND PACKAGING ISSUE WITH THE CLOSUREFAST 7F 100CM CATHETER, AS THERE WAS NO STERILE PLASTIC WRAPPING AROUND THE PLASTIC TRAY CONTAINING THE CATHETER. THIS ISSUE WAS DISCOVERED PRIOR TO USE, AND THE DEVICE WAS NOT USED IN A PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21320862 ↗

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

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Sources and updates

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