VenaSeal VS-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521539921), received between Jun 28, 2017 and May 31, 2018 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Misfire” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P140018); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH VENASEAL TO CLOSE A DISEASED GREAT SAPHENOUS VEIN(GSV). THE PROCEDURE WAS PREPARED AS PER IFU AND THE PROCEDURE WAS COMPLETED AS NORMAL. A FEW HOURS POST PROCEDURE, THE PATIENT EXPERIENCED HEADACHES AND TACHYCARDIA. PATIENT HAS REPORTED EXPERIENCING THESE EVENTS IN THE PAST, BUT THIS TIME THE SYMPTOMS WERE NOT TRANSIENT. THE PATIENT HAD A CARDIAC WORKUP, WHICH WAS NEGATIVE AND DID NOT HAVE EVIDENCE OF A DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAD NO SYMPTOMS OF PULMONARY EMBOLUS(PE) AND A CT FOR PE WAS NEGATIVE. PATIENT HAD SOME TRANSIENT PHLEBITIS, WHICH RESOLVED. THE PATIENT DID NOT HAVE HIVES OR REDNESS OR ITCHING IN THE TREATMENT ZONE OR ANYWHERE ELSE. THE PATIENT HAS HAD AN ECHOCARDIOGRAM(ECG), STRESS TEST AND HAS WORN A HOLTER MONITOR, WHICH HAVE BEEN NEGATIVE. MRI OF THE BRAIN HAS ALSO BEEN NEGATIVE. A SLEEP APNEA STUDY HAS BEEN ORDERED BY THE PATIENT¿S CARDIOLOGIST. CARDIAC PALPITATIONS AND FLUSHING EPISODES HAVE CONTINUED POST PROCEDURE. NO RASH WAS REPORTED. THE PHYSICIAN WILL MONITOR THE PATIENT CLOSELY AND HAS PRESCRIBED AN ORAL STEROID TO ALLEVIATE SYMPTOMS.

  Patient problems: Headache; Tachycardia

  MAUDE report 7555979 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED FENASAL TREATMENT TO CLOSE BILATERAL GREAT SAPHENOUS VEINS (GSV). THE IFU WAS FOLLOWED AND THE PROCEDURE WAS COMPLETED AS NORMAL AND THE VEINS SUCCESSFULLY CLOSED. IT IS REPORTED THAT THE GLUE WAS AMPLE DISTANCE BACK FROM THE SFJ. SEVENTY TWO HOURS POST PROCEDURAL A SCAN SHOWED A THROMBUS EXTENDING INTO THE COMMON FEMORAL OF THE RIGHT LEG AND THE PATIENT REPORTED SWELLING AND TEND ERNESS IN THEIR RIGHT LEG. THE PATIENT WAS PRESCRIBED ELIQUIS FOR ONE MONTH AND WILL REVISIT THE PHYSICIAN.

  Patient problems: Swelling; Thrombus

  MAUDE report 7539903 ↗
• InjuryDec 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS TREATED FOR VENOUS INSUFFICIENCY USING VENASEAL TREATMENT. A 90 CM SEGMENT OF THE GSV AND A 14 CM SEGMENT OF THE SSV WERE CLOSED USING VENASEAL. A 3.8 CM OF PRODUCT WAS USED. THE IFU WAS FOLLOWED WITH NO ISSUES IDENTIFIED. ONE WEEK POST IMPLANT THE PATIENT HAD A TEMPERATURE OF 99 DEGREES. PATIENT DOES NOT APPEAR TO HAVE ALLERGIES. PATIENT WAS PRESCRIBED KEFLEX AND PAIN PILLS. THE PATIENT HAD AN INFECTED VARICOSITY REMOVED. THE PATIENT HAS A WOUND VAC AND IS SCHEDULED TO LEAVE THE HOSPITAL SOON.

  Patient problems: Fever; Patient Problem/Medical Problem

  MAUDE report 7078657 ↗
• InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD BILATERAL GREAT SAPHENOUS VEINS (GSV) TREATED WITH VENASEAL CLOSURE SYSTEM, THE RIGHT LEG WAS TREATED IN (B)(6) 2016 AND THE LEFT LEG WAS TREATED ONE MONTH LATER, IN (B)(6) 2016. THE PATIENT REPORTED ((B)(6) 2017) OF HAVING SIDE EFFECTS POST PROCEDURE, WHICH PRESENTED AS VEIN LEAKAGE IN HER LEGS, A BLOOD CLOT AND SCARRING FOR WHICH SHE IS NOW SEEKING ADDITIONAL MEDICAL TREATMENT. IN FOLLOW-UP ON (B)(6) 2017, THE PATIENT REPORTED THAT SHE HAD EXPERIENCED SCARRING AT THE ENTRY POINT ON RIGHT LEG, VEIN LEAKAGE AND BLOOD POOLING, WHICH HAD CAUSED REDNESS AND WEEPING ACROSS THE ANKLE AREA. PATIENT ALSO REPORTED THAT SHE HAD EXPERIENCED THROMBOPHLEBITIS IN THE LEFT LEG AFTER THE VENASEAL TREATMENT, WHICH WAS CONFIRMED BY AN ULTRASOUND DURING A FOLLOW-UP APPOINTMENT, BLOOD POOLING IN LEFT LEG CAUSING REDNESS AND WEEPING ACROSS THE ANKLE AREA. PATIENT WAS SEEN BY A WOUND SPECIALIST AND A VASCULAR PHYSICIAN FOR CONSULTATION ON (B)(6) 2017. AFTER PERFORMING BILATERAL ULTRASOUNDS, PATIENT WAS PROVIDED WITH JUXTAFIT COMPRESSION WRAPS.

  Patient problems: Inflammation; Thrombus; Vasculitis

  MAUDE report 6963761 ↗
• MalfunctionAug 16, 2017Partial Blockage; Misfire; Partial Blockage; Misfire

  PHYSICIAN USED OF VENASEAL CLOSURE SYSTEM TO TREAT BOTH THE RIGHT AND LEFT GSV UNDER LOCAL ANESTHESIA. IT WAS REPORTED THAT THE IFU WAS FOLLOWED. APPROXIMATELY 45CM OF THE VEIN ON LEFT LEG WHICH WAS CLOSED SUCCESSFULLY. IT WAS REPORTED THAT WHILE TREATING THE RIGHT GSV, THE VENASEAL GLUE GUN STOPPED CLICKING WHEN TRIGGER WAS PRESSED. IT WAS ALSO NOTICED POST PROCEDURE THAT GUN PLUNGER WAS ONLY ENGAGING WITH TRIGGER SPORADICALLY REQUIRING SEVERAL TRIGGER-PULLS TO ENGAGE THE PLUNGER. TWO SEGMENTS WERE TREATED AND THE PROCEDURE WAS ENDED WITHOUT CLOSING RIGHT GSV. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799694 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A VENASEAL CLOSURE SYSTEM TO TREAT VENOUS INSUFFICIENCY IN THE GREAT SAPHENOUS VEIN UNDER LOCAL ANESTHETIC. THE LUMEN WAS NOT FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED DURING PREP, PROCEDURE AND POST PROCEDURE. A GUIDEWIRE WAS USED DURING THE INSERTION OF THE CATHETER. HAND COMPRESSION WAS USED. IT WAS REPORTED THAT, POST OP, THE PATIENT HAD SIGNIFICANT BRUISING ALONG THE LENGTH OF THE TREAT VEIN. THE PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS. IT WAS REPORTED THAT PATIENT¿S CONDITION IMPROVED AFTER TAKING PRESCRIBED MEDICATIONS.

  Patient problems: Bruise/Contusion

  MAUDE report 6766903 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED THE VENASEAL TO TREAT THE GREAT SAPHENOUS VEIN AS PER IFU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AT THE TIME. IT WAS REPORTED THE PATIENT PRESENTED WITH AN INFECTION AT THE ACCESS SITE 12 MONTHS POST PROCEDURE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND ANTIBIOTIC CREAM.

  Patient problems: Unspecified Infection

  MAUDE report 6675924 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140018. One submission often covers many models, so check the product and lot details in each record.

• Z-1564-2021 · Mar 23, 2021 · Terminated
  VenaSeal Closure System
• Z-1599-2015 · Apr 28, 2015 · Terminated
  VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.