ClosureFast CF7-7-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521058057), received between May 5, 2017 and Nov 17, 2020 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2020Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER WITH AN RFG2 DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). IFU WAS FOLLOWED. A GUIDEWIRE WAS NOT USED FOR INSERTION OF THE CATHETER. IT IS REPORTED WHEN THE CATHETER WAS CONNECTED TO THE RFG2 IT WAS NOT RECOGNIZED. A ¿CATHETER NOT RECOGNIZED¿ MESSAGE WAS DISPLAYED ON THE RFG2. THE RFG2 WAS POWER CYCLED AND THE ERROR REMAINED. A SECOND CATHETER WAS USED WITH THE SAME RFG2 WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. BASED ON THE EVENT DATE PROVIDED, THIS CATHETER WAS ATTEMPTED TO BE USED POST EXPIRY. IT IS UNCLEAR IF THE PHYSICIAN KNEW THAT THE DEVICE WAS USED PAST IT EXPIRATION DATE. IT IS UNKNOWN IF THE DEVICE WAS USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10850105 ↗
• MalfunctionJan 28, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED CLOSUREFAST DEVICE WAS USED TO TREAT A PATIENT WITH VENOUS INSUFFICIENCY. THERE WERE NO PATIENT SYMPTOMS AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281585 ↗
• MalfunctionApr 17, 2018Device Expiration Issue; Device Expiration Issue

  AN EXPIRED CLOSUREFAST WAS USED WITHOUT ISSUE. NO MISSING, UNCLEAR, OR INCORRECT LABEL, LOT NUMBER, EXPIRATION DATE, OR IFU/PACKAGE INSERT INFORMATION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435557 ↗
• InjuryMar 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A CLOSURE FAST CATHETER WITH AN RFG3 GENERATOR TO TREAT BOTH THE GREAT SAPHENOUS VEIN (GSV) AND THE SHORT SAPHENOUS VEIN (SSV). THE IFU WAS FOLLOWED. AT THE BEGINNING OF THE PROCEDURE THE GENERATOR DISPLAYED AN ERROR MESSAGE THAT THE TEMPERATURE WAS TOO LOW TO INITIATE TREATMENT BUT AFTER CLICKING ON OK THE TREATMENT WAS CARRIED OUT NORMALLY. DURING THE PROCEDURE THE GSV WAS SUCCESSFULLY TREATED BUT DURING TREATMENT OF THE SSV THE PATIENT FELT PAIN AND THE DEVICE WAS STOPPED AFTER 15 SECONDS IN A SEGMENT BELOW THE CALF. ACCESS POINT WAS MADE IN THE MALLEOLUS. HAND COMPRESSION WAS USED AND THE VEIN WAS SUCCESSFULLY CLOSED. THE PATIENT WAS STILL REPORTING PAIN A DAY LATER. ACCORDING TO THE PHYSICIAN, SURAL AND SAPHENOUS NERVES ARE DAMAGED DUE TO THE PROCEDURE. HE THINKS THAT THIS MAY BE TEMPORARY.

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 7305606 ↗
• MalfunctionJan 5, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN USED A CLOSUREFAST TO TREAT 4 SEGMENTS OF THE ANTERIOR LATERAL ACCESSORY VEIN. THE IFU WAS FOLLOWED AND THE DEVICE WAS NOT REPROCESSED. THE PHYSICIAN THEN INTENDED TO USE THE SAME DEVICE TO TREAT THE GREAT SAPHENOUS VEIN(GSV). BEFORE PROCEEDING TO THE GSV, THE PHYSICIAN NOTICED THAT THE THERMOCOUPLE HAD MELTED. A NEW CATHETER WAS OPENED AND THE PHYSICIAN PROCEEDED TO SUCCESSFULLY TREAT THE GSV WITH THIS NEW CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167067 ↗
• MalfunctionDec 21, 2017Kinked; Defective Device; Kinked; Defective Device

  THE PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER TO TREAT A VENOUS INSUFFICIENCY IN THE GSV. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PHYSICIAN ATTEMPTED TO TREAT A SEGMENT PROXIMAL TO THE SFJ AND AN ERROR MESSAGE APPEARED ON THE GENERATOR. THE COIL PORTION OF THE CATHETER KINKED. THE PHYSICIAN USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137517 ↗
• MalfunctionDec 1, 2017Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER FOR TREATMENT OF GREAT SAPHENOUS VEIN (GSV) UNDER GENERAL ANAESTHESIA USING TRANSDUCER COMPRESSION. IT IS REPORTED THAT AFTER TUMESCENT INFILTRATION IT WAS NOTED THE CATHETER WOULD NOT REACH OPERATIONAL TEMPERATURE. A NEW CATHETER WAS OPENED TO COMPLETE THE PROCEDURE. ONE SEGMENT WAS TREATED AND THE VEIN CLOSED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074820 ↗
• InjuryNov 17, 2017Kinked; Kinked

  THE PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST 7F 100 CM CATHETER WITH A RFG2 GENERATOR FOR THE RADIOFREQUENCY ABLATION TREATMENT IN TWO SEGMENTS OF THE GSV AND SSV IN A TORTUOUS VESSEL. THE IFU WAS FOLLOWED FOR DEVICE PREPARATION AND PROCEDURE. THE LUMEN WAS FLUSHED, AND A GUIDEWIRE/ INSERTION CATHETER WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE THE CATHETER WAS NOT RESPONDING/RECOGNIZED AND THE DOCTOR COULD NOT ADVANCE THE CATHETER AFTER A COUPLE OF SEGMENTS. TUMESCENT INFILTRATION, IV SEDATION AND LOCAL ANAESTHESIA WERE USED FOR THE PROCEDURE. THIS CATHETER WAS NOT USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING PERFORATION AND FOAM SCLEROTHERAPY IN THE SSV. POST PROCEDURE, CLASS II COMPRESSION STOCKINGS WERE USED. NO PATIENT SYMPTOMS, COMPLICATIONS OR INJURY WERE REPORTED. CATHETER KINK IN USE/ PREP WAS ALSO REPORTED BY THE PHYSICIAN BUT NO DAMAGE WAS NOTED TO THE PACKAGING OF THE CATHETER.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7041420 ↗
• InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A CLOSUREFAST CATHETER TO PERFORM RADIOFREQUENCY ABLATION TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV). 4 SEGMENTS WERE TREATED (BOTH GSV'S AND BOTH SSV'S) AND THE VEIN DID CLOSE. THESE PROCEDURES WERE CARRIED OUT OVER 2 DAYS - RIGHT GSV AND RIGHT SSV TREATED WITH RF ABLATION ON THE FIRST PROCEDURE DAY. LEFT GSV AND LEFT SSV TREATED WITH RF ABLATION ON THE SECOND PROCEDURE DAY. IFU WAS FOLLOWED AND THE PROCEDURE WAS CARRIED OUT AS NORMAL. DURING FOLLOW-UP (APPROXIMATELY 2-3 WEEKS LATER), IT WAS OBSERVED THAT SKIN IRRITATION, BLISTERING AND ULCERATIONS HAD DEVELOPED AND PROGRESSIVELY WORSENED, AND PATIENT EXPERIENCED PAIN, SWELLING, AND REDNESS. THE PATIENT¿S FAMILY REPORTED THAT A CREAM WAS APPLIED TO THE SKIN IRRITATION SITES AND THAT THE PATIENT IS ALLERGIC TO A COMPONENT IN THE CREAM - IT WAS UNKNOWN WHAT CREAM OR COMPONENT IN THE CREAM THE PATIENT WAS ALLERGIC TO. ADDITIONAL TREATMENT REQUIRED INCLUDED WOUND THERAPY AND COMPRESSION. PATIENT WAS REFERRED TO ANOTHER CLINIC FOR POSSIBLE VEN A SEAL PROCEDURE; REFERRAL PHYSICIAN DID NOT SEE ANY NEED TO TREAT WITH VENA SEAL, SINCE ALL SUPERFICIAL VEINS PREVIOUSLY TREATED WERE CLOSED. A SMA

  Patient problems: Inflammation; Pain; Reaction

  MAUDE report 7023176 ↗
• MalfunctionNov 10, 2017Kinked; Material Integrity Problem; Kinked; Material Integrity Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER WITH A RFG3 FOR RADIOFREQUENCY ABLATION TREATMENT. IT WAS REPORTED THAT DURING POWERING ON, THE GENERATOR DISPLAYED THE MESSAGE "DEFECTIVE CATHETER". NO MOISTURE WAS FOUND ALONG THE DEVICE AND NO SPLASHING EVENTS OCCURRED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023155 ↗
• InjuryNov 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER FOR A RADIOFREQUENCY ABLATION TREATMENT IN THE GREAT SAPHENOUS VEIN (GSV) USING LOCAL ANESTHESIA AND HAND COMPRESSION. THE DEVICE IFU WAS FOLLOWED. A GUIDEWIRE WAS NOT USED FOR INSERTION OF THE CATHETER. IT WAS REPORTED THAT WHILE ADDING TUMESCENT TO THE JUNCTION, THE CATHETER DID NOT RESPOND TO THE TEMPERATURE CHANGE. CUSTOMER STATED THAT THEY STARTED TREATMENT AND AT THE JUNCTION COULD NOT GET THE GENERATOR TO STAY AT 120 DEGREES. AFTER A COUPLE OF TREATMENTS, THE CATHETER WAS PULLED BACK A BIT AND GOT THE TEMPERATURE TO STAY AT 120 DEGREES. IT WAS REPORTED THAT THE RFG WAS TURNED OFF AND REBOOTED TO CONTINUE THE TREATMENT. THIS WAS CARRIED OUT 5-6 TIMES TO COMPLETE THE PROCEDURE WITH THE SAME CATHETER. ON A FOLLOW-UP VISIT DURING THE NEXT WEEK, IT WAS FOUND THAT THE VEIN DID NOT CLOSE AND THE PROCEDURE WAS NOT SUCCESSFUL INITIALLY. ANOTHER RADIOFREQUENCY ABLATION PROCEDURE WAS CARRIED OUT ON THE PATIENT A COUPLE OF WEEKS LATER WITHOUT INCIDENT, PROCEDURE WENT WELL AND THE VEIN STILL DID NOT CLOSE. PATIENT IS GETTING VEIN STRIPPING PERFORMED BELIEVING THAT A THERMAL PROCEDURE WILL NOT WORK ON THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7011959 ↗
• MalfunctionAug 21, 2017Device Damaged by Another Device; Device Damaged by Another Device

  PHYSICIAN USED A CLOSUREFAST CATHETER AND 0.025 GUIDEWIRE FOR RADIOFREQUENCY ABLATION TREATMENT OF THE GREATER SAPHENOUS VEIN (GSV). IT WAS REPORTED THAT THE GUIDEWIRE WAS USED TO MANEUVER THE CATHETER UP THE VEIN. WHEN THE PHYSICIAN TRIED TO REMOVE THE GUIDEWIRE, IT GOT STUCK IN THE CATHETER. IT WAS REPORTED THAT THERE WERE SEVERAL CENTIMETERS OF GUIDEWIRE EXTENDING OUT OF THE END OF THE CATHETER. SINCE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE FROM THE CATHETER, BOTH THE CATHETER AND GUIDEWIRE WERE BOTH REMOVED. DURING INSPECTION OF THE GUIDEWIRE, IT WAS NOTICED THAT IT LOOKED LIKE THE OUTER COATING BROKE AND THE END FOR THE GUIDEWIRE WAS CONNECTED BY JUST THE ENTER COIL. THE ULTRASOUND TECH AND PHYSICIAN LOOKED TO SEE IF ANY OF THE PIECES OF GUIDEWIRE WERE LEFT INSIDE THE VEIN. THEY COULD NOT DETERMINE IF ANY OF THE GUIDEWIRE REMAINED IN THE VEIN USING ULTRASOUND AND THEY ALSO PULLED THEIR ¿C-ARM¿ AND TOOK SOME FLUOROSCOPIC IMAGES THAT DIDN'T SHOW ANY RETAINED METAL. THE VEIN WAS NOT ABLATED, BUT ANOTHER VEIN WAS SUCCESSFULLY ABLATED USING A NEW CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806613 ↗
• MalfunctionJul 27, 2017Material Deformation; Material Deformation

  PHYSICIAN USED A CLOSUREFAST CATHETER FOR RADIOFREQUENCY ABLATION PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV) WITH THE USE OF TUMESCENT INFILTRATION UNDER LOCAL ANESTHESIA. DEVICE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE PROCEDURE PROCEEDED AS NORMAL AND THE VEIN CLOSED AS EXPECTED. AFTER REMOVING THE CATHETER, THE PHYSICIAN NOTED THAT THE COIL HAD UNRAVELED SLIGHTLY. IT WAS CONFIRMED BY ULTRASOUND THAT NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749358 ↗
• MalfunctionJul 14, 2017Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN USED A CLOSUREFAST CATHETER FOR RADIOFREQUENCY ABLATION PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV) UNDER LOCAL ANAESTHESIA. THE LUMEN WAS FLUSHED BEFORE USE AND THE IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. CORRECT TEMPERATURE WAS REACHED. TUMESCENT INFILTRATION AND TRANSDUCER COMPRESSION WERE USED. IT WAS REPORTED THAT AFTER DELIVERING ONE CYCLE NEAR THE JUNCTION, THE CATHETER STOPPED WORKING. THERE WAS NO MESSAGE DISPLAYED ON THE GENERATOR. DIFFICULTY WAS EXPERIENCED WHEN REMOVING THE CATHETER FROM THE GSV DUE TO THE TUMESCENT. ANOTHER CATHETER WAS SUCCESSFULLY USED WITH THE GENERATOR TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. FOLLOWING ANALYSIS OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE CLOSUREFAST COIL SEEMS TO BE FRAYED APART FROM THE END OF THE CATHETER SHAFT AT THE BASE OF THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713649 ↗
• MalfunctionJul 7, 2017Material Deformation; Material Deformation

  PHYSICIAN WAS USING A CLOSUREFAST CATHETER FOR RADIOFREQUENCY ABLATION PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV) USING TUMESCENT INFILTRATION AND COMPRESSION (HAND) UNDER LOCAL ANESTHESIA. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE AND THE LUMEN WAS FLUSHED PRIOR TO USE. CORRECT TEMPERATURE WAS REACHED. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE BEFORE FINAL TREATMENT THERE WAS A ¿CATHETER BROKEN¿ MESSAGE WAS DISPLAYED. ANOTHER CATHETER WAS USED WITH THE SAME GENERATOR WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THE VEIN WAS SUCCESSFULLY CLOSED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693753 ↗
• MalfunctionJun 23, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER TO PERFORM RADIOFREQUENCY ABLATION PROCEDURE OF THE GREAT SAPHENOUS VEIN. IT WAS REPORTED THE CLOSUREFAST WAS UNABLE TO REACH TEMPERATURE, THE GENERATOR DISPLAYED ERROR CODE ¿REPLACE CATHETER¿. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME GENERATOR NO ISSUES NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6665642 ↗
• MalfunctionJun 21, 2017Kinked; Material Deformation; Kinked; Material Deformation

  PHYSICIAN WAS USING A CLOSUREFAST CATHETER WITH AN RFG2 GENERATOR FOR A RADIOFREQUENCY ABLATION PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV). THE LUMEN WAS FLUSHED BEFORE USE AND THE IFU WAS FOLLOWED. PROCEDURE WAS CARRIED OUT UNDER GENERAL ANESTHESIA WITH THE USE OF TUMESCENT INFILTRATION AND TRANSDUCER COMPRESSION. CORRECT TEMPERATURE WAS REACHED. ON COMPLETION OF THE PROCEDURE, ONE KINK WAS OBSERVED ON THE COIL OF THE CATHETER. ALL SEGMENTS WERE TREATED AND THE VEIN CLOSED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6659315 ↗
• MalfunctionMay 22, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO TREAT PATIENT USING A CLOSUREFAST CATHETER. CATHETER WAS INSERTED INTO THE PATIENT. IT IS REPORTED THAT GENERATOR DISPLAYED AN ERROR MESSAGE STATING CATHETER WAS UNABLE TO BE RECOGNISED. UPON REMOVAL OF THE CATHETER, ONE KINK WAS NOTED TO THE HEATING COIL. A SECOND CLOSUREFAST CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6581609 ↗
• MalfunctionMay 5, 2017Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE GREAT SAPHENOUS VEIN USING A CLOSUREFAST CATHETER WITH A RFG2 GENERATOR. TRANSDUCER COMPRESSION AND TUMESCENT INFILTRATION WERE USED. IFU WAS FOLLOWED. IT IS REPORTED THAT CATHETER WAS UNABLE TO REACH CORRECT TEMPERATURE AND WATTAGE DURING THE PROCEDURE. WHEN PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT, THEY NOTED 1-2 KINKS ON THE OUTER SHAFT OF THE DEVICE. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. WHEN DEVICE RETURNED TO THE EVALUATION FACILITY, IT WAS NOTED THAT THE FEP WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546899 ↗