ClosureFastRecalls & reported problems across all models

We found 8 models of ClosureFast by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 283 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2017 and Sep 24, 2026 — classified as 60 injuries, 223 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (133 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ClosureFast problems

ClosureFast models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ClosureFast™ CF7-7-100

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  95 reports
• ClosureFast™ CF7-7-60

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  80 reports
• ClosureFast™ CF6-8-60

  Electrosurgical, cutting & coagulation & accessories
  40 reports
• ClosureFast™ CF7-7-100

  Electrosurgical, cutting & coagulation & accessories
  24 reports
• ClosureFast™ CF7-7-60

  Electrosurgical, cutting & coagulation & accessories
  21 reports
• ClosureFast™ CF6-8-100

  Electrosurgical, cutting & coagulation & accessories
  15 reports
• ClosureFast™ CF7-3-60

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  6 reports
• ClosureFast™ CF7-3-60

  Electrosurgical, cutting & coagulation & accessories
  2 reports

Recent ClosureFast adverse event reports

The 15 most recent reports across all models, 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 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; 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 ↗
• 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 ↗
• MalfunctionSep 16, 2026Overheating of Device; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785609 ↗
• 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 ↗
• 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 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 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 ↗
• 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 ↗
• 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 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 ↗

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