ClosureFast™ CF7-7-60 (UDI 00763000702281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000702281), received between Dec 2, 2024 and Sep 22, 2026 — classified as 2 injuries, 19 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Leak/Splash

  A Closurefast RFA Catheter was intended to be used, it was reported  the catheter was found to be leaking during use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851490 ↗
• MalfunctionSep 18, 2026Overheating of Device; Activation, Positioning or Separation Problem

  It was reported that lower extremity venous insufficiency in two great saphenous vein segments was treated with the ClosureFast catheter using tumescent infiltration, local anesthesia, and hand compression. The ablation effect was poor, and the treated vein did not close. The procedure was completed using a catheter from another brand. The patient was alive with no injury. Additional information: When the device was returned for evaluation, it was noted that the catheter was damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814441 ↗
• InjurySep 9, 2026Overheating of Device; Deformation Due to Compressive Stress

  It was reported that a Closurefast catheter was being used to treat the Great saphenous vein (GSV). Tumescent infiltration, local anesthesia and hand compression were utilized.  A guidewire was used for the insertion of the catheter. The proper temperature was reached. During the procedure the catheter became kinked on the coil. The catheter was replaced with a new one, and the procedure completed, two segments were treated and the vein closed. The lumen was flushed prior to use and the IFU (Instruction for Use) was followed during preparation, procedure, post-procedure. No patient complications have been reported as a result of this event. When the device was returned for evaluation, it was noted that the catheter was damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684888 ↗
• MalfunctionMay 22, 2026Overheating of Device; Output Problem

  IT WAS REPORTED THAT A PHYSICIAN PLACED THE LONG CATHETER JUST BEFORE THE CROSS WITHOUT ANY PROBLEMS, THEN ADMINISTERED THE TUMESCENT SOLUTION AND BEGAN RADIOFREQUENCY THERAPY. THE FIRST CYCLES STARTED, THEN A MESSAGE APPEARED ON THE GENERATOR: ¿LOW TEMPERATURE, ADJUST COMPRESSION.¿ DESPITE ADJUSTING THE CATHETER SLIGHTLY DOWNWARDS AND WITHOUT COMPRESSION, IT WOULDN¿T GO ANY FURTHER. PHYSICIAN TRIED STARTING THE CYCLES SEVERAL TIMES, BUT THEY KEPT STOPPING AFTER 2¿3 SECONDS WITH THE MESSAGE: ¿TEMPERATURE CANNOT BE REACHED, TERMINATION¿. EVEN CHANGING THE GENERATOR OR PLACING THE CATHETER DEEPER MADE NO DIFFERENCE; THERAPY WAS IMPOSSIBLE. PHYSICIAN THEN INSERTED A NEW RF CATHETER, WHICH WORKED ABSOLUTELY FINE. HOWEVER, CATHETER COULD NO LONGER PUSH ALL THE WAY TO THE GROIN, BUT ONLY ABOUT 10 CM OR DEEPER BELOW THE GROIN. THE FIRST CATHETER MUST HAVE HAD SOME EFFECT HERE, AS IT ALSO LOOKED VERY STRANGE. NO ALLEGATION AGAINST THE RFG. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE COIL WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256359 ↗
• MalfunctionMay 22, 2026Overheating of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A CLOSUREFAST CATHETER WAS USED TO TREAT VENOUS INSUFFICIENCY OF THE GREAT SAPHENOUS VEIN UNDER GENERAL ANESTHESIA WITH TUMESCENT INFILTRATION AND HAND COMPRESSION. THE CATHETER WAS FLUSHED PRIOR TO USE, PROPER TEMPERATURE WAS REACHED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED. AFTER THREE CYCLES, BUBBLING WAS NOTED TO THE FEP LINER, WITH BURNT RESIDUE AND A KINK ALSO OBSERVED. THE BARE COIL WAS NOT EXPOSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND VEIN CLOSURE WAS ACHIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253335 ↗
• MalfunctionMay 18, 2026Overheating of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A CLOSUREFAST 7F 60 CM CATHETER WAS USED DURING AN ENDOVENOUS PROCEDURE TO TREAT VENOUS INSUFFICIENCY OF THE GREAT SAPHENOUS VEIN, WITH THE FULL LENGTH TREATED AND THE VEIN REPORTED AS CLOSED. TUMESCENT INFILTRATION WAS UTILIZED WITH LOCAL ANESTHESIA, AND HAND COMPRESSION WAS USED. PROPER TEMPERATURE WAS REACHED. POST-PROCEDURE, THE HEATING ELEMENT WAS REPORTED TO BE BENT. THE PROCEDURE WAS REPORTED AS COMPLETED PER THE INSTRUCTIONS FOR USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT TH COIL WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200957 ↗
• MalfunctionApr 23, 2026Overheating of Device

  IT WAS REPORTED THAT A CLOSUREFAST INTRAVASCULAR RADIOFREQUENCY ABLATION CATHETER WAS USED TO TREAT LOWER EXTREMITY VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN WITH LOCAL ANESTHESIA AND TUMESCENT INFILTRATION. THE LUMEN WAS FLUSHED PRIOR TO USE, NO GUIDEWIRE WAS USED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED. COMPRESSION WAS NOT USED. THE GENERATOR OPERATED NORMALLY, PROPER TEMPERATUREWAS REACHED, AND NO ERROR MESSAGES WERE DISPLAYED DURING RADIOFREQUENCY DELIVERY; AFTER RADIOFREQUENCY COMPLETION, COATING DAMAGE IN THE HEATING SECTION WAS OBSERVED ONLY AFTER THE CATHETER WAS WITHDRAWN. FIVE SEGMENTS WERE TREATED AND THE VEIN CLOSED. NO PATIENT SYMPTOMS, COMPLICATIONS, OR ADDITIONAL TREATMENT WERE REPORTED, AND THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24963181 ↗
• MalfunctionFeb 23, 2026Overheating of Device

  A CLOSUREFAST RFA CATHETER WAS BEING USED FOR TREATMENT OF 5~6 SEGMENTS OF THE GREAT SAPHENOUS VEIN (GSV). COMPRESSION WAS NOT USED. TUMESCENT INFILTRATION WAS USED. IT WAS REPORTED AFTER THE FIRST GSV PROCEDURE, THE CATHETER HEATING COIL CARBONIZED, MAKING IT IMPOSSIBLE TO PERFORM THE SECOND GSV PROCEDURE. A NEW CATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413122 ↗
• MalfunctionFeb 5, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE PRODUCT PACKAGING WAS DAMAGED ON THE REVERSE OF THE INNER STERILE POUCH FOR THE CF7-7-60 CLOSUREFAST 7F 60CM CATHETER PRIOR TO USE. THE PACKAGING DAMAGE WAS EVIDENT BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267249 ↗
• MalfunctionJan 7, 2026Overheating of Device; Impedance Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CF7-7-60 CLOSUREFAST 7F 60 CM CATHETER, A GENERATOR OR DISPLAY ISSUE OCCURRED. SPECIFICALLY, THE GENERATOR POWERED ON BUT THE SCREEN DID NOT COME ON, AND THE GENERATOR LATER STOPPED WITH THE DISPLAY SHOWING LOW IMPEDANCE. THE CATHETER COULD NOT BE USED. THE LUMEN WAS FLUSHED PRIOR TO USE, A GUIDEWIRE WAS USED FOR INSERTION, AND PROPER TEMPERATURE WAS REACHED. WHEN THE OPERATOR PRESSED ABLATION BUTTON OF THE RFA CATHETER, CATHETER'S TEMPERATURE WAS HIGH NOT 120 DEGREE. THE OPERATOR CONTINUED WITH THE PROCEDURE DESPITE THE DISPLAY ISSUE, BUT ULTIMATELY USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE. NO ADDITIONAL TREATMENT WAS REQUIRED. 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 DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989557 ↗
• InjuryOct 20, 2025Electrical /Electronic Property Problem; Detachment of Device or Device Component; Impedance Problem; Electrical /Electronic Property Problem; Detachment of Device or Device Component; Impedance Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE GREAT SAPHENOUS VEIN USING THE CLOSUREFAST DEVICE, THE GENERATOR REPORTED EQUIPMENT FAILURE ON THE FIFTH CYCLE. UPON REMOVAL OF THE DEVICE, IT WAS OBSERVED THAT THE HEATING ELEMENT HAD DETACHED, AND THE METAL COIL WAS EXPOSED AND HAD UNRAVELED, RESULTING IN AN ESTIMATED 5 CM SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT. THE RFG3 DISPLAYED IMPEDANCE ISSUE MESSAGE AND CATHETER NOT RESPONDING/RECOGNISED. THE PATIENT WAS BROUGHT TO RECOVERY AND THEN TAKEN BACK INTO THEATRE FOR AN OPEN SURGICAL PROCEDURE AT THE MID-THIGH, DURING WHICH THE VEIN WAS TIED IN AN ATTEMPT TO RETRIEVE THE RETAINED SECTION, BUT IT COULD NOT BE LOCATED. AN URGENT ULTRASOUND SCAN WAS PERFORMED TO MAP THE LOCATION OF THE RETAINED DEVICE SECTION. THE PATIENT WAS SUBSEQUENTLY TAKEN BACK TO THEATRE FOR A SECOND OPEN SURGICAL PROCEDURE TO EXCISE THE RETAINED SECTION.TUMESCENT INFILTRATION AND COMPRESSION WERE UTILIZED DURING THE PROCEDURE, AND FIVE SEGMENTS OF THE GREAT SAPHENOUS VEIN WERE TREATED. THE VEIN WAS CONFIRMED TO BE CLOSED. THE PATIENT WAS REPORTED TO BE FIT AND WELL FOLLOWING THE PROCEDURES AND WAS DISCHARGED THE SAME DAY. NO PATIENT C OMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344237 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR LOWER EXTREMITY VENOUS INSUFFICIENCY USING THE CLOSUREFAST 7F 60CM CATHETER DURING A PROCEDURE ON THE GREAT SAPHENOUS VEIN, WITH TWO SEGMENTS TREATED UNDER LOCAL ANESTHESIA AND TUMESCENT INFILTRATION. AN ABNORMALITY WAS OBSERVED ON THE HEATING ELEMENT SURFACE OF THE CATHETER AFTER TWO TREATMENT CYCLES, SPECIFICALLY AT 1 CM FROM THE TAIL, WHERE IT WAS SUSPECTED THAT BLOOD HAD BURNED AND ADHERED TO THE HEATING ELEMENT. THE ADHESION WAS REMOVED BY GENTLY USING A SCALPEL. THE PROCEDURE WAS COMPLETED BY REPLACING THE AFFECTED CATHETER WITH ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277588 ↗
• MalfunctionSep 18, 2025Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR LOWER EXTREMITY VENOUS INSUFFICIENCY USING THE CLOSUREFAST 7F 60CM CATHETER DURING A PROCEDURE ON THE GREAT SAPHENOUS VEIN. THE RED MARK WAS ALIGNED WHEN THE CONNECTOR WAS INSERTED INTO THE GENERATOR. A CATHETER CONNECTION PROBLEM WAS IDENTIFIED; ISSUES WERE NOTED WHEN CONNECTING/REMOVING THE CATHETER TO/FROM THE GENERATOR. THE PINS WERE NOT BENT; THE RFG RECEPTACLE WAS NOT INSPECTED AND ALL THE PINS REMAINED ON THE CATHETER CONNECTOR. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND HAND COMPRESSION WAS APPLIED. THE VEIN CLOSED SUCCESSFULLY, AND ONLY ONE SEGMENT WAS TREATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE COIL WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081773 ↗
• MalfunctionSep 9, 2025Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  IT WAS REPORTED THAT THE COATING OF THE HEATING SECTION OF THE CF7-7-60 CLOSUREFAST 7F 60CM CATHETER WAS DAMAGED PRIOR TO USE. THE ISSUE WAS NOTED WHEN DEVICE WAS REMOVED FROM THE PACKAGING. THE DEVICE WAS NOT USED/TESTED IN VITRO. THE CATHETER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED. 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 23002476 ↗
• MalfunctionAug 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HEATING ELEMENT OF THE CF7-7-60 CLOSUREFAST 7F 60CM CATHETER LOST ITS INTEGRITY. THE LUMEN WAS FLUSHED PRIOR TO USE, INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE, AND A GUIDEWIRE WAS NOT USED FOR INSERTION. THE PROPER TEMPERATURE WAS REACHED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED BEFORE THE ISSUE WAS IDENTIFIED, 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 22698022 ↗
• MalfunctionApr 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT LOWER EXTREMITY VENOUS INSUFFICIENCY USING A CLOSUREFAST 7F 60CM CATHETER, THE HEATING SECTION AT THE TIP END OF THE CATHETER WAS DAMAGED AND WAS STICKING, CAUSING ADHESION DURING THE RADIOFREQUENCY PROCESS. THE GREAT SAPHENOUS VEIN WAS BEING TREATED UNDER GENERAL ANESTHESIA WITH TUMESCENT INFILTRATION. THE PROCEDURE INVOLVED ONE SEGMENT, AND THE LUMEN WAS FLUSHED PRIOR TO USE. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THE ISSUE WAS RESOLVED BY REPLACING THE DAMAGED CATHETER WITH A NEW MEDTRONIC CATHETER, ALLOWING THE SURGERY TO PROCEED NORMALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918632 ↗
• MalfunctionApr 28, 2025Overheating of Device; Impedance Problem; Overheating of Device; Impedance Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY VARICOSE VEIN ABLATION PROCEDURE USING THE CF7-7-60 CLOSUREFAST 7F 60CM CATHETER, THE CATHETER COIL WAS BURNT/MELTED/BUBBLING. THE RADIOFREQUENCY GENERATOR DISPLAYED A "LOW IMPEDANCE" ERROR WHEN THE FIBER WAS DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917022 ↗
• MalfunctionFeb 6, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT LOWER EXTREMITY VENOUS INSUFFICIENCY USING A CLOSUREFAST CATHETER, THE CATHETER DID NOT FUNCTION AFTER BEING CONNECTED TO THE HOST AND THE START BUTTON WAS CLICKED. THE CATHETER WAS RE-INSERTED AND UNPLUGGED SEVERAL TIMES BUT CONTINUED TO MALFUNCTION. THE PROCEDURE INVOLVED THE TREATMENT OF THE GREAT SAPHENOUS VEIN, UTILIZING TUMESCENT INFILTRATION AND GENERAL ANESTHESIA, WITH HAND COMPRESSION APPLIED. THE OPERATION WAS COMPLETED AFTER REPLACING THE MALFUNCTIONING CATHETER WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE COIL WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321292 ↗
• MalfunctionJan 22, 2025Overheating of Device; Output Problem; Overheating of Device; Output Problem

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST DEVICE TO TREAT THE GREAT SAPHENOUS VEIN. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED. THE LUMEN WAS FLUSHED PRIOR TO USE, A GUIDEWIRE WAS NOT USED FOR THE INSERTION OF THE CATHETER. HAND COMPRESSION WAS UTILIZED. PROPER TEMPERATURE WAS NOT REACHED, CATHETER TEMPERATURE THERMOCOUPLE. CATHETER HEATING ELEMENT COATING DAMAGED WAS REPORTED, THE COIL WAS NOT EXPOSED. THE PATIENT HAD GSV CLOSURE OF BOTH LOWER LIMBS, AND THE LEFT LEG HAD BEEN COMPLETELY CLOSED. WHEN THE RIGHT LEG GSV WAS CLOSED, IT WAS FOUND THAT THE CATHETER SHEATH COULD NOT BE INSERTED. THERE WERE NO ERROR CODES/MESSAGES/WARNINGS FROM THE GENERATOR. AFTER THE PROBLEM WAS DISCOVERED DURING THE SURGERY, A NEW CATHETER WAS USED TO COMPLETE THE OPERATION. TWO SEGMENTS WERE TREATED, AND THE VEIN CLOSED. NO ADDITIONAL TREATMENT REQUIRED AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206043 ↗
• MalfunctionJan 10, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN USING A CF7-7-60 CLOSUREFAST 7F 60 CM CATHETER, A CATHETER BURN OCCURRED. THE TEMPERATURE WAS AT 120 DEGREES CELSIUS. TUMESCENT INFILTRATION AND LOCAL ANESTHESIA WERE UTILIZED, AND COMPRESSION WAS APPLIED USING A TRANSDUCER. THE VEIN SUCCESSFULLY CLOSED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADDITIONAL TREATMENT REQUIRED. NO GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124225 ↗
• 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 20819525 ↗

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