VenaSeal™ VS-404Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00763000240776), received between Apr 21, 2021 and Jul 21, 2026 — classified as 2 deaths, 120 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (90 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 23, 2021Terminated

   Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

   Z-1564-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Delivered as Unsterile Product; Device Difficult to Setup or Prepare; Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25886563 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING TREATMENT WITH THE VENASEAL CLOSURE SYSTEM, A PATIENT WAS IDENTIFIED AS HAVING A PROBABLE GLUE EXTENSION CONSISTENT WITH EHIT KABNICK CLASS 2, WITH PROPAGATION APPROXIMATELY 1 CM INTO THE COMMON FEMORAL VEIN AND OCCUPYING ABOUT 11% OF THE COMMON FEMORAL VEIN LUMEN. THE EVENT WAS REPORTED IN THE LEFT GREAT SAPHENOUS VEIN. MULTIPLE ULTRASOUND EXAMINATIONS WERE PERFORMED AND SHOWED NO CHANGE IN THE THROMBUS OR GLUE OVER AN APPROXIMATELY 6-WEEK PERIOD. MEDICAL INTERVENTION WAS PROVIDED WITH PRESCRIPTION PLAVIX FOR APPROXIMATELY 6 WEEKS. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AND ALIVE WITH NO INJURY, AND THE THROMBUS OR GLUE WAS REPORTED TO STILL BE PRESENT. THE CLINIC DID NOT CONFIRM THE COMPLICATION UNTIL THE 6 WEEK FOLLOW UP. AT THAT TIME THE GLUE WAS STABLE, AND THE PATIENT WAS ASYMPTOMATIC, SO THEY WERE NOT DOING ANY FOLLOW UP. THE PATIENT IS NOT RECEIVING FURTHER TREATMENT, ISSUE IS STILL PRESENT BUT STABLE. CLINICIAN IS NOT TRACKING IT ANYMORE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25886411 ↗
• InjuryJul 7, 2026Nonstandard Device

  IT WAS REPORTED THAT A VENASEAL PROCEDURE WAS PERFORMED FOR VENOUS INSUFFICIENCY INVOLVING THE BILATERAL GREAT SAPHENOUS VEINS AND B ILATERAL SMALL SAPHENOUS VEINS. TWO VENASEAL KITS WERE USED DURING THE PROCEDURE. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SPJ. COMPRESSION OF SSV WAS UTILIZED. AT AN APPROXIMATELY 72-HOUR ULTRASOUND FOLLOW-UP, A NON-OCCLUSIVE THROMBUS EXTENSION FROM THE RIGHT SMALL SAPHENOUS VEIN INTO THE POPLITEAL VEIN WAS IDENTIFIED AND WAS REPORTED AS EGIT 3 WITH AN EXTENSION OF APPROXIMATELY 4.78 CM, AND THERE WAS UNCERTAINTY WHETHER THE FINDING REPRESENTED GLUE EXTENSION OR THROMBUS. THE ULTRASOUND TECHNOLOGIST STATED THEY DID NOT THINK THE FINDING WAS GLUE EXTENSION. THE PHYSICIAN REPORTED A CONCERN THAT SOMETHING WAS WRONG WITH THE DELIVERY GUN AND THAT IT DELIVERED MORE GLUE THAN INTENDED. ANTICOAGULATION THERAPY WAS INITIATED AND THE PATIENT WAS PRESCRIBED ELIQUIS. AT A SUBSEQUENT ULTRASOUND AND PHYSICIAN VISIT APPROXIMATELY ONE WEEK LATER, THE THROMBUS EXTENSION INTO THE POPLITEAL VEIN WAS REPORTED TO HAVE REGRESSED TO APPROXIMATELY 4.41 CM AND REMAIN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25732525 ↗
• InjuryApr 13, 2026Biocompatibility

  A PHYSICIAN USED A VENASEAL CLOSURE SYSTEM DURING AN ABLATION PROCEDURE OF THE PATIENTS LEFT GREAT SAPHENOUS VEIN (GSV) AND ANTERIOR ACCESSORY SAPHENOUS VEIN (AASV) ON (B)(6) 2025. POST-OP, THE PATIENT HAD AN ALLERGIC REACTION TO THE VENASEAL. THE PATIENT PRESENTED ON 18-(B)(6) 2025 WITH PAIN AND ERYTHEMA OF THE MEDIAL THIGH, NOT ASSOCIATED WITH ANY INCISIONS. ULTRASOUND SHOWED SOME CLOT IN BRANCH VARICOSITIES. THE PATIENT WAS STARTED ON DOXYCYCLINE FOR BOTH ANTIMICROBIAL AND ANTI-INFLAMMATORY PROPERTIES. THE PATIENT RETURNED ON (B)(6) 2025 WITH ERYTHEMA AND DISCOLORATION ON THE MEDIAL LEG DOWN TO THE ANKLE AND TO A LESSER EXTENT ON THE ANTERIOR THIGH. ULTRASOUND AGAIN SHOWED SOME BRANCH VEIN THROMBOSIS BUT NOT ENOUGH TO ACCOUNT FOR THE CLINICAL APPEARANCE. THERE WAS NO EVIDENCE OF ABSCESS OR OTHER SIGN OF INFECTION. THE PHYSICIAN SENT THE PATIENT TO THE LAB FOR A COMPLETE BLOOD COUNT (CBC), ERYTHROCYTE SEDIMENTATION RATE (ESR), C-REACTIVE PROTEIN (CRP), AND PRO-CALCITONIN TESTS. ALL TESTS WERE NORMAL EXCEPT THE CRP WHICH WAS 117 (NORMAL 5). THE PATIENT WAS STARTED ON PREDNISONE 5MG BY MOUTH DAILY UNTIL THE CRP NORMALIZED, WHICH TOOK ABOUT 6 WEEKS. AT THAT TIME THE PHYSICIAN PERFOR

  Patient problems: Erythema; Local Reaction; Pain; Skin Discoloration; Thrombosis/Thrombus

  MAUDE report 24858146 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE USING THE VENASEAL CLOSURE SYSTEM TO TREAT A SOFT TISSUE LESION IN THE PATIENTS LEFT PROXIMAL GREAT SAPHENOUS VEIN, THE PATIENT EXPERIENCED GROIN PAIN THAT WAS NOTED AT AN INITIAL FOLLOW-UP ULTRASOUND SCAN. THE ONSET OF SYMPTOMS WAS DAYS 2-14 AFTER PROCEDURE. THE INITIAL FOLLOW-UP SCAN REPORTEDLY SHOWED NO OCCLUSION, AND THE PHYSICIAN INSTRUCTED THE PATIENT TO TAKE BABY ASPIRIN. AT A SUBSEQUENT FOLLOW-UP ULTRASOUND SCAN ON (B)(6) 2026, THROMBUS/OCCLUSION WAS IDENTIFIED. THE THROMBUS WAS REPORTED TO HAVE STARTED IN THE GREAT SAPHENOUS VEIN BETWEEN THE FIRST GLUE DELIVERY SITE AND THE SAPHENOFEMORAL JUNCTION, WITH THROMBUS EXTENSION FROM THE SAPHENOFEMORAL JUNCTION. THE THROMBUS WAS NOT IN THE DEEP VEIN. IMAGES WERE UNCLEAR AS TO WHETHER SUSPECTED EXTENSION TO THE JUNCTION REPRESENTED THROMBUS OR GLUE. THE PATIENT WAS TREATED WITH ELIQUIS FOR 30 DAYS AND THE GROIN PAIN SUBSIDED AFTER STARTING ELIQUIS.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24843513 ↗
• InjuryMar 30, 2026Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENASEAL PROCEDURE AND SUBSEQUENTLY EXPERIENCED AN ADVERSE REACTION CHARACTERIZED BY RASH AND ANAPHYLAXIS TWO WEEKS POST-OPERATION. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ANAPHYLAXIS, WHICH WAS CONSIDERED A LIFE-THREATENING ILLNESS/INJURY AND REQUIRED HOSPITALIZATION. MEDICAL INTERVENTION INCLUDED ADMINISTRATION OF AN EPIPEN AND A STEROID PRESCRIPTION (40MG TAPER, THEN 80MG). THE REACTION OCCURRED OUTSIDE THE TREATMENT AREA AND WAS THE INITIAL REACTION EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Local Reaction; Rash

  MAUDE report 24726767 ↗
• InjuryMar 30, 2026Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE INVOLVING THE VENASEAL, THE PATIENT EXPERIENCED A CLINICAL REACTION CHARACTERIZED BY A RASH THAT DEVELOPED OUTSIDE THE TREATMENT AREA, SPECIFICALLY NOT IN THE AXIAL ARTERY OR VEIN. ONLY ONE LEG WAS TREATED AND THE REACTION WAS ON THAT LEG. THE ONSET OF SYMPTOMS OCCURRED BETWEEN DAYS 2 AND 14 AFTER THE PROCEDURE, AND THIS WAS THE INITIAL REACTION EVENT. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING. ADDITIONAL INFORMATION RECEIVED 04 MARCH 2026 MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS TREATED WITH A PRESCRIPTION STEROID (MEDTROL DOSE PACK) BUT SYMPTOMS PERSISTED. THE AFFECTED LOCATIONWAS THE PERIPHERAL VEIN(S), INCLUDING THE GREAT SAPHENOUS VEIN, WITH INVOLVEMENT NOTED IN PROXIMAL, MID, AND DISTAL SEGMENTS. NO CHALLENGES OR DEVIATIONS RELATED TO THE LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE, THE CATHETER TIP WAS 5 CM CAUDAL TO SFJ AND COMPRESSION OF GSV WAS APPLIED. SYMPTOMS DID NOT RESOLVE AND THE VEIN WAS REMOVED ON 2/12 AND THE PATIENT IS REPORTED TO BE OK NOW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Rash

  MAUDE report 24712866 ↗
• MalfunctionMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL VEIN CLOSURE PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV)  USING THE VENASEAL CLOSURE SYSTEM VS-404, THERE WAS A DELAY IN SURGERY OF FIVE MINUTES DUE TO PRODUCT ISSUES. THE SPIN LOCK WOULD NOT STAY CLOSED DURING THE PROCEDURE, CAUSING THE GLUE DELIVERY CATHETER TO BE REPEATEDLY PULLED OUT OF THE INTRODUCER. THIS DEVICE DETACHMENT ISSUE OCCURRED WITHIN THE VESSEL, REQUIRING REMOVAL AND REPLACEMENT OF THE DEVICE DURING THE PROCEDURE. THE DEVICE WAS PUT BACK TOGETHER VIA THE SPIN LOCK AND REMOVED SAFELY FROM THE PATIENT AS WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER VENASEAL KIT. MANUAL COMPRESSION WAS UTILIZED, THE LUMEN WAS FLUSHED PRIOR TO USE, AND A GUIDEWIRE FROM THE VS KIT WAS USED FOR CATHETER INSERTION. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE VEIN WAS SUCCESSFULLY CLOSED, AND NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, INJURIES, INFECTIONS, OR DEATHS WERE REPORTED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636688 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CLOSURE OF PERIPHERAL VEIN(S), SPECIFICALLY THE GREAT SAPHENOUS VEIN (GSV), USING THE VENASEAL CLOSURE SYSTEM, THE BLUE CATHETER BROKE UPON REMOVAL HALFWAY DOWN THE SHAFT. THERE WAS NO KINK AND IT OCCURRED WHILE IN THE PATIENT. IT WAS A CLEAN BREAK, STRAIGHT ACROSS. THE DEVICE WAS EXPLANTED. LOCAL ANESTHESIA WAS UTILIZED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE VEIN CLOSURE WAS ACHIEVED. THE PROCEDURE WAS COMPLETED DESPITE THE CATHETER BREAKING UPON REMOVAL. NO PATIENT COMPLICATIONS OR INJURY HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511461 ↗
• InjuryJan 17, 2026Biocompatibility

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A VENASEAL VS-404 TO TREAT A SOFT TISSUE LESION IN THE LEFT PROXIMAL MID SHORT SAPHENOUS VEIN (SSV). PATIENT HAD AN ADHESIVE PLUG. PATIENT HAD LEFT SSV VENASEAL PROCEDURE ON ((B)(6)). PATIENT STARTED DEVELOPING OPEN WOUNDS ON THE DISTAL 1/3 OF THE LEG AROUND MID SEPTEMBER AND KEPT DEVELOPING MORE AND PROGRESSING HIGHER TO THE POPLITEAL JUNCTION REGION. PHYSICIAN SAID THEY WERE UNSURE IT WAS GRANULOMA. PHYSICIAN IS NOT THE ONE TREATING IT, BUT A DERMATOLOGIST. DERMATOLOGIST HAD TREATED THE PATIENT FOR ANTIBIOTICS FLUCLOXACILLIN FOR CELLULITIS. ACCORDING TO THE DERMATOLOGIST, PIECES OF HARD SUBSTANCES KEPT COMING OUT AND THE 3 SWAB BIOPSIES PERFORMED ALSO KEPT SHOWING UP WITH PSEUDOMONAS. PHYSICIAN SAID IF IT DID NOT HAVE PSEUDOMONAS, PHYSICIAN WOULD HAVE LEFT IT ALONE AND OBSERVED IT. SINCE THERE WAS PSEUDOMONAS, THEY PLANNED TO EXCISE AND EXPLANT THEM, THE SSV.

  Patient problems: Granuloma; Unspecified Infection

  MAUDE report 24105429 ↗
• MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CLOSURE SYSTEM VS-404 VENASEAL US EA TO TREAT A LESION IN THE PROXIMAL MID GREAT SAPHENOUS VEIN (GSV). THE LUMEN FLUSHED WAS PRIOR TO USE. THE 035" GUIDE WIRE THAT COMES IN KIT WAS USED. LOCAL ANESTHESIA WAS USED. HAND/MANUAL COMPRESSION WAS USED. BLUE CATHETER COULD NOT BE SCREWED INTO WHITE DELIVERY CATHETER. DETACHMENT OF THE SCREW IN PART OF CATHETER OCCURRED. DEVICE SAFELY REMOVED FROM PATIENT. VEIN CLOSED. PROCEDURE COMPLETED WITH THE DEVICE IN QUESTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848808 ↗
• InjuryDec 10, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A LESION IN THE RIGHT MID AND DISTAL GREAT SAPHENOUS VEIN WITH THE VENASEAL CLOSURE SYSTEM. POST-OP, THE PATIENT EXPERIENCED HYPERSENSITIVITY, SKIN IRRITATION, ITCHING, GRANULOMA, AS WELL AS SEVERAL ULCERATIONS ON THE RIGHT LEG. ONLY ONE LEG WAS TREATED. THIS WAS A RECURRENT PROCESS. THE BLUE INTRODUCER WAS USED. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SFJ. THE REACTION AND GRANULOMA OCCURRED ALONG THE TREATED VEIN, MORE THAN 5 CM FROM THE ACCESS SITE, AND THE ONSET OF SYMPTOMS WAS AT LEAST SIX MONTHS AFTER THE PROCEDURE. THE DIAMETER OF THE TREATED VEIN WAS 6.25 MM. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING.

  Patient problems: Granuloma; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; Ulcer

  MAUDE report 23768118 ↗
• InjuryNov 27, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A VENASEAL CLOSURE SYSTEM PROCEDURE INVOLVING THE GREAT SAPHENOUS VEIN, A PATIENT DESCRIBED REMOVING "GRAVEL" (CHUNKS OF GLUE) FROM THEIR LEGS AND EXPERIENCED MILD INFLAMMATION AT THE AREA. A GRANULOMA WAS IDENTIFIED ALONG THE TREATED VEIN, MORE THAN 5 CM FROM THE ACCESS SITE. ULTRASOUND IMAGES AND PHOTOGRAPHS DEPICTING THE CONDITION WERE AVAILABLE. THE EVENT WAS ASSOCIATED WITH THE GREAT SAPHENOUS VEIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL OR MEDICAL INTERVENTION. THE ISSUE WAS REPORTED AS RESOLVED. THE AREA IS INFLAMED. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Granuloma

  MAUDE report 23665666 ↗
• InjuryNov 13, 2025Biocompatibility; Biocompatibility

  THE INITIAL VENASEAL PROCEDURE WAS UNEVENTFUL, BOTH AT THE PROCEDURE AND AT THE PATIENT¿S 48 HOUR POSTOPERATIVE VISIT ON (B)(6) 2025. IT WAS REPORTED DURING A ROUTINE 6 WEEK FOLLOW-UP FOLLOWING THE INITIAL IMPLANT PROCEDURE USING THE VENASEAL CLOSURE SYSTEM IN THE RIGHT GREAT SAPHENOUS VEIN, THE PATIENT EXPERIENCED HARDENING AND DISCOMFORT ALONG THE COURSE OF THE VEIN, A SMALL RED TENDER PIMPLE-LIKE AREA ON THE RIGHT MEDIAL LOWER LIMB. ON (B)(6) 2025 PATIENT CALLED THE CLINIC TO REQUEST RECOMMENDATIONS FOR BANDAGING OF PREVIOUSLY UNREPORTED OPEN SORES ALONG THE GSV. AT THAT TIME, A SCABBED SORE ALONG THE RIGHT MEDIAL UPPER CALF, AND A LARGER SCABBED SORE IN THE RIGHT MEDIAL THIGH WITH SURROUNDING REDNESS WAS NOTED. THE WOUNDS WORSENED AND BECAME MORE NUMEROUS ALONG THE GREAT SAPHENOUS VEIN, ACCOMPANIED BY SWELLING, SKIN INFLAMMATION, SKIN IRRITATION, SKIN DISCOLORATION, AND RASH. A POSSIBLE DIAGNOSIS OF PYODERMA GANGRENOSUM WAS CONSIDERED. THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS AND ZYRTEC 20MG DAILY AND WAS REFERRED TO A DERMATOLOGIST FOR FOLLOW-UP. THE TREATED VEIN WAS 53CM IN LENGTH, WITH A DIAMETER OF 4.5MM, AND 1.7ML OF ADHESIVE WAS USED. THE ISSUE REMAINED P

  Patient problems: Inflammation; Local Reaction; Rash; Skin Discoloration; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 23543238 ↗
• InjuryNov 5, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A VENASEAL PROCEDURE USING THE CLOSURE SYSTEM VS-404, THE PATIENT EXPERIENCED REDNESS AND PAIN AT THE MEDIAL THIGH WITHOUT ITCHING, SWELLING AND ITCHING OF BOTH LEGS (WORSE ON THE LEFT), AND A HYPERSENSITIVITY REACTION DIAGNOSED BY THE OFFICE.THE LEFT LEG WAS TREATED ON THE (B)(6) 2025 AND THE RIGHT LEG WAS TREATED ON THE (B)(6) 2025. THE PATIENT HAD A LESION AT THE LEFT GREAT SAPHENOUS VEIN MID SEGMENT, A LESION AT THE RIGHT LEG (TREATED, SYMPTOMS NOT SPECIFIED), AND A LESION AT A SOFT TISSUE SITE. THE PATIENT WAS TREATED WITH PRESCRIPTION ANTIBIOTICS FOR REDNESS AND IT WAS UNCLEAR AT THE TIME IF IT IS A TRUE CELLULITIS INFECTION. THE PATIENT HAS AN AUTOIMMUNE DISORDER THAT WAS UNKNOWN UNTIL FOLLOW UP VISITS. PATIENT WAS DIAGNOSED WITH HYPERSENSITIVITY AND OVER-THE-COUNTER ANTIHISTAMINE WAS PRESCRIBED FOR THE HYPERSENSITIVITY REACTION. AS OF THE LATEST FOLLOW-UP, SYMPTOMS WERE RESOLVING. NO DEATHS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Swelling/ Edema

  MAUDE report 23477229 ↗
• InjuryNov 5, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A VENASEAL PROCEDURE USING THE CLOSURE SYSTEM VS-404, THE PATIENT EXPERIENCED REDNESS AND PAIN AT THE MEDIAL THIGH WITHOUT ITCHING, SWELLING AND ITCHING OF BOTH LEGS (WORSE ON THE LEFT), AND A HYPERSENSITIVITY REACTION DIAGNOSED BY THE OFFICE.THE LEFT LEG WAS TREATED ON THE (B)(6) 2025 AND THE RIGHT LEG WAS TREATED ON THE (B)(6) 2025. THE PATIENT HAD A LESION AT THE LEFT GREAT SAPHENOUS VEIN MID SEGMENT, A LESION AT THE RIGHT LEG (TREATED, SYMPTOMS NOT SPECIFIED), AND A LESION AT A SOFT TISSUE SITE. THE PATIENT WAS TREATED WITH PRESCRIPTION ANTIBIOTICS FOR REDNESS AND IT WAS UNCLEAR AT THE TIME IF IT IS A TRUE CELLULITIS INFECTION. THE PATIENT HAS AN AUTOIMMUNE DISORDER THAT WAS UNKNOWN UNTIL FOLLOW UP VISITS. PATIENT WAS DIAGNOSED WITH HYPERSENSITIVITY AND OVER-THE-COUNTER ANTIHISTAMINE WAS PRESCRIBED FOR THE HYPERSENSITIVITY REACTION. AS OF THE LATEST FOLLOW-UP, SYMPTOMS WERE RESOLVING. NO DEATHS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Swelling/ Edema

  MAUDE report 23477203 ↗
• InjuryNov 3, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE INVOLVING THE VENASEAL US EA FOR TREATMENT OF VARICOSITIES IN THE RIGHT THIGH, THE PATIENT DEVELOPED POST-OPERATIVE CELLULITIS, PAIN, AND PHLEBITIS. THE CELLULITIS INFECTION WAS NOTED TO HAVE PRESENTED AT THE MID THIGH, NOT AT THE SITE OF ACCESS, WHICH WAS OBTAINED AT THE MID CALF, AND THERE WAS NO ITCHING AT THE SITE OF REDNESS. THE PATIENT ALSO HAD A HEALING ULCER AT FOLLOW-UP. THE PATIENT LEFT THE EMERGENCY DEPARTMENT AGAINST MEDICAL ADVICE AND WAS LATER EVALUATED IN CLINIC, WHERE IMPROVEMENT AND ULCER HEALING WERE NOTED IN THE TREATED LEG. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING PRESCRIPTION ANTIBIOTICS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cellulitis; Pain; Ulcer; Vasculitis

  MAUDE report 23450891 ↗
• InjuryNov 3, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PROCEDURE INVOLVING THE  VENASEAL US EA FOR TREATMENT OF THE RIGHT GREAT SAPHENOUS VEIN AT THE MID LOCATION WAS ADMITTED TO THE HOSPITAL WITH A POSITIVE BLOOD CULTURE FOR SEPSIS. THE PATIENT EXPERIENCED A LIFE-THREATENING ILLNESS AND WAS FOUND TO HAVE AN INFECTION AT THE PERIPHERAL VEIN SITE, SPECIFICALLY THE RIGHT GREAT SAPHENOUS VEIN, MID LOCATION. REDNESS AND INFLAMMATION ASSOCIATED WITH MID THIGH PHLEBITIS WERE OBSERVED, AS CONFIRMED BY DUPLEX ULTRASOUND IMAGING. ADDITIONAL TESTING REVEALED A POSITIVE STREP A CULTURE. THE PATIENT REMAINED HOSPITALIZED WITH ONGOING SYMPTOMS AND INJURY.

  Patient problems: Sepsis; Skin Inflammation/ Irritation; Unspecified Infection; Vasculitis

  MAUDE report 23450280 ↗
• InjuryOct 17, 2025Biocompatibility; Biocompatibility

  PATIENT HAD ONE LEG TREATED WITH VENASEAL ON (B)(6) 2025. ELEVEN DAYS LATER, ON (B)(6) 2025, PATIENT DEVELOPED A FULL BODY ALLERGIC REACTION, SYMPTOMS INCLUDE GENERALISED HIVES, ITCHING, BLURRED VISION, AND SHORTNESS OF BREATH. THE PATIENT WAS THEN SENT TO THE ERON (B)(6) 2025 AND RECEIVED STEROIDS VIA IV. THERE WAS NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE DURING THE PROCEDURE. ALTHOUGH, DUE TO A VEIN SPASM THE PHYSICIAN HAD TO ACCESS TWICE. 45CM WAS TREATED WITH 2CC OF ADHESIVE. VESSEL WIDTH WAS 5.3MM. ACCESSED AT CALF. THE CATHETER TIP WAS 5CM CAUDAL TO SFJ. THE GSV WAS COMPRESSED. THE BLUE INTRODUCER WAS USED. ISSUE HAS SINCE RESOLVED.

  Patient problems: Blurred Vision; Dyspnea; Hypersensitivity/Allergic reaction; Itching Sensation; Urticaria

  MAUDE report 23320969 ↗
• InjurySep 30, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A VENASEAL CLOSURE SYSTEM PROCEDURE, A PATIENT DEVELOPED GRANULOMA ALONG THE TREATED GREAT SAPHENOUS VEIN IN BOTH THE RIGHT AND LEFT LEGS, INVOLVING THE PROXIMAL, MID, AND DISTAL SEGMENTS. ABNORMALITIES IN THE BILATERAL GREAT SAPHENOUS VEIN ANATOMY WERE ALSO NOTED. 37CM OF THE RIGHT SHORT SAPHENOUS VEIN, 65CM OF THE RIGHT GREAT SAPHENOUS VEIN, AND 34M OF THE LEFT GREAT SAPHENOUS VEIN WERE TREATED. THE GRANULOMA WAS STILL PRESENT AT THE TIME OF THE REPORT. MEDICAL INTERVENTION WAS REQUIRED, AND ORAL STEROIDS WERE ADMINISTERED. PRE-SCREENING QUESTIONNAIRE REVIEWED WITH PATIENT. NO TO ALL QUESTIONS. PATIENT¿S GRANULOMA IS IMPROVING SINCE MEDICATION AS BEEN GIVEN.

  Patient problems: Granuloma

  MAUDE report 23179153 ↗
• InjurySep 11, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER A PROCEDURE INVOLVING THE CLOSURE SYSTEM VS-404 VENASEAL, GRANULOMA FORMATION OCCURRED ALONG THE MID PORTION OF THE LEFT GREAT SAPHENOUS VEIN, MORE THAN 5 CM FROM THE ACCESS SITE. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING A PRESCRIPTION FOR STEROIDS. SURGICAL INTERVENTION WAS ALSO PLANNED, WITH THE PHYSICIAN DECIDING TO EXPLANT GRANULOMAS THAT HAD LEFT THE VEIN. THE ISSUE WAS STILL PRESENT AT THE TIME OF REPORTING. THE DATE OF IMPLANT WAS (B)(6) 2024. THERE WERE CHALLENGES RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE, UNABLE TO PASS TO JUNCTION DUE TO SPASM. THE CATHETER TIP WAS NOT 5CM CAUDAL TO SFJ, IT WAS MUCH MORE THAN 5 CM DUE TO SPASM IN THE VEIN. COMPRESSION OF GSV WAS UTILIZED. THE DATE OF THE VEIN EXCISION/EXPLANT IS (B)(6) 2025.

  Patient problems: Granuloma; Vasoconstriction

  MAUDE report 23025386 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO VENASEAL KITS WERE USED TO TREAT THE GREAT SAPHENOUS VEIN. APPROXIMATELY 27 MONTHS POST PROCEDURE PATIENT SUFFERED INTERMITTENT LEFT THIGH ACHE. PATIENT REPORTED THAT THEIR PRE-ENROLMENT LEFT THIGH SHARP PAIN HAD RETURNED OVER THE PAST TWO MONTHS INTERMITTENTLY. THIS RESULTED IN A VISIT, PHYSICIAN RECOMMENDED USUAL CONSERVATIVE TREATMENT. PATIENT REPORTED IMPROVEMENT OVER THE PAST FEW WEEKS., PATIENT REPORTED INTERMITTENT THIGH ACNE WITH NO PAIN AT THE TIME OF THE VISIT. THE EVENT WAS TREATED WITH ASPIRIN, COUMADIN AND FREQUENT ELEVATION OF LIMBS. IT WAS STATED THAT THE EVENT WAS RELATED TO TARGET LIMB/VEIN. PATIENT HAS NOT RECOVERED.

  Patient problems: Pain

  MAUDE report 23018739 ↗
• InjuryAug 1, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENASEAL CLOSURE PROCEDURE ON (B)(6) 2025. ONLY ONE LEG WAS TREATED. THE PHYSICIAN CHOSE NOT TO USE THE BLUE INTRODUCER. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SFJ. THIRTEEN DAYS AFTER THE PROCEDURE ((B)(6) 2025), THE PATIENT EXPERIENCED A HYPERSENSITIVITY RESPONSE AND WAS PRESCRIBED BENADRYL. A FEW DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A RASH ACROSS THE TORSO, NECK, AND FACE AND WAS PRESCRIBED PREDNISONE. THE HYPERSENSITIVITY RESPONSE RESOLVED, AS THE PATIENT DID NOT RETURN FOR FURTHER EVALUATION OF THE RASH. APPROXIMATELY TWO MONTHS AFTER THE PROCEDURE ((B)(6) 2025), THE PATIENT PRESENTED TO THE CLINIC WITH AN ULCER/WOUND FORMATION ON THE MEDIAL LEFT KNEE AND PROXIMAL CALF, CORRESPONDING TO THE AREA OF PRE-OPERATIVE LARGER VARICOSE VEINS. THERE WAS ALSO A SCABBED OVER AREA AT THE LOCATION OF THE PROCEDURAL ACCESS SITE AND A GRANULOMA NEAR THE ACCESS SITE WITHIN 5 CM. THE GRANULOMA WAS STILL PRESENT AT THE TIME OF REPORTING. THE PATIENT WAS REFERRED TO INFECTIOUS DISEASE.

  Patient problems: Granuloma; Hypersensitivity/Allergic reaction; Ulcer

  MAUDE report 22685225 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STROKE OCCURRED THE DAY AFTER A VENASEAL PROCEDURE. THE PATIENT PRESENTED AT THE HOSPITAL WITH STROKE-LIKE SY MPTOMS AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO THE STROKE. THE STROKE REMAINS UNRESOLVED. THE PROCEDURE INVOLVED THE GREAT SAPHENOUS VEIN IN THE PERIPHERAL VEINS, THOUGH THE SPECIFIC SIDE WAS UNKNOWN. THE DOCTOR DID NOT BELIEVE THE STROKE WAS A RESULT OF THE VENA SEAL PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Stroke/CVA

  MAUDE report 22077810 ↗
• InjuryMay 22, 2025Biocompatibility; Biocompatibility

  MEDTRONIC PATIENT SERVICES RECEIVED A CALL ABOUT A SYSTEMIC ALLERGIC REACTION THAT OCCURRED AFTER A VENASEAL PROCEDURE. PATIENT HAD 2 VENASEAL IMPLANTS ON (B)(6) 2025 & (B)(6) 2025. THE ONSET OF SYMPTOMS WAS A COUPLE OF DAYS AFTER HER FIRST PROCEDURE. BOTH SMALL SAPHENOUS VEINS (SSV) WERE TREATED AND REACTION WAS PRESENT IN BOTH. THERE WERE NO CHALLENGES OR DEVIATIONS RELATED TO LOCATION OF CATHETER TIP PRIOR TO INITIAL DELIVERY OF ADHESIVE. THE CATHETER TIP WAS 5CM CAUDAL TO SFJ. COMPRESSION WAS UTILIZED. THE VASCULAR SURGEON CHOSE TO REPEAT USAGE OF N-BUTYL CYANOACRYLATE AFTER HE REALIZED (FROM FIRST EXPOSURE) THE PATIENT WAS ALLERGIC TO CYANOACRYLATE WHICH CAUSED AND CONTINUES TO CAUSE A DAILY SEVERE SYSTEMIC ALLERGIC REACTION THAT HAS LASTED 44 DAYS SO FAR. THE PATIENT SHAKES, IS FEVERISH, EXPERIENCES CHILLS, LOW BLOOD PRESSURE, FULL BODY OR PARTIAL BODY ITCHING (HIVES), RED INFLAMED SKIN, PALPITATIONS, SHORTNESS OF BREATH, NAUSEA, HEAD AND FACE ARE HOT AND FEEL FLUSH EVERY DAY. CONCOMITANT MEDICAL PRODUCTS AND OTHER TREATMENTS INCLUDE 81MG ASPIRIN, RESTASSIS, ROSUVASTATIN, & VESICARE. A MEDRAL DOSE PACK WAS PRESCRIBED AND ACCORDING TO THE PHYSICIAN THE ITCHING HAD LARGELY DISA

  Patient problems: Arrhythmia; Chills; Dyspnea; Erythema; Fever; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; Local Reaction; Low Blood Pressure/ Hypotension; Nausea

  MAUDE report 22068272 ↗