VenaCure EVLTRecalls & reported problems across all models
Angiodynamics, Inc. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 437
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 0
We found 15 models of VenaCure EVLT by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 437 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2015 and May 6, 2026 — classified as 50 injuries, 387 malfunctions.
The most frequently reported specific device problem is “Fracture” (226 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
Reports received per month, all models
Most reported VenaCure EVLT problems
Device problems
- Fracture226
- Crack102
- Detachment of Device or Device Component53
- Device Damaged Prior to Use45
- Detachment Of Device Component17
- Thermal Decomposition of Device15
- Adverse Event Without Identified Device or Use Problem14
- Melted12
Patient problems
- No Clinical Signs, Symptoms or Conditions136
- No Consequences Or Impact To Patient110
- No Known Impact Or Consequence To Patient78
- Device Embedded In Tissue or Plaque42
- No Patient Involvement42
- Foreign Body In Patient22
- Burn(s)9
- Thrombus7
VenaCure EVLT models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VenaCure EVLT EVLT/PVAKPowered laser surgical instrument123 reports
- VenaCure EVLT 11403002Powered laser surgical instrument87 reports
- VenaCure EVLT 11403101ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES52 reports
- VenaCure EVLT EVLT/55-OPSPowered laser surgical instrument40 reports
- VenaCure EVLT 11403001Powered laser surgical instrument35 reports
- VenaCure EVLT EVLTPVAKUSPowered laser surgical instrument25 reports
- VenaCure EVLT EVLT/25-OPSPowered laser surgical instrument16 reports
- VenaCure EVLT 11403013Powered laser surgical instrument15 reports
- VenaCure EVLT EVLT/80-OPSPowered laser surgical instrument12 reports
- VenaCure EVLT 11403006Powered laser surgical instrument8 reports
- VenaCure EVLT 11403004Powered laser surgical instrument7 reports
- VenaCure EVLT 51403002Powered laser surgical instrument6 reports
- VenaCure EVLT 11403005Powered laser surgical instrument4 reports
- VenaCure EVLT 11403012Powered laser surgical instrument4 reports
- VenaCure EVLT 11403003Powered laser surgical instrument3 reports
Recent VenaCure EVLT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING TWO PVAK -- 400 MICRON FIBER PROCEDURE KITS. THE FIRST FIBER WAS NOTED AS BENT WHEN IT WAS REMOVED FROM THE PACKAGING. A SECOND FIBER WAS OPENED FOR THE PROCEDURE, HOWEVER, IT BROKE WHEN INSERTING IT. THE FIBER HAD NOT BEEN FIRED YET. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 25096720 ↗MalfunctionApr 8, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PVAK -- 400 MICRON FIBER PROCEDURE KIT. AT THE CLOSING OF AN EVLT PROCEDURE, THE PHYSICIAN WAS PULLING BACK ON THE FIBER AND FELT HEAT THROUGH THE FIBER INTO HIS FINGERS. HE THEN FELT THE FIBER BREAK IN HALF. THERE WAS ABOUT 1/2" OF THE FIBER STICKING OUT OF THE SHEATH, SO HE WAS ABLE TO GRAB THE RETAINED PORTION AND FULLY REMOVE IT FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 24818716 ↗MalfunctionFeb 3, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. DURING THE EVLT PROCEDURE, THE FIBER FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. THIS REQUIRED AN ADDITIONAL INCISION TO REMOVE THE FRAGMENT. THE PHYSICIAN REPORTED THAT HE FOLLOWED THE ESTABLISHED PROCEDURE AND USED THE FIBER INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 24250884 ↗MalfunctionFeb 3, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. DURING THE EVLT PROCEDURE, THE FIBER FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. THIS REQUIRED AN ADDITIONAL INCISION TO REMOVE THE FRAGMENT, HOWEVER THE ATTEMPT TO REMOVE THE FRAGMENT WAS UNSUCCESSFUL AND THE FRAGMENT WAS RETAINED IN THE SAPHENOFEMORAL JUNCTION. THE PHYSICIAN REPORTED THAT HE HAD FOLLOWED THE ESTABLISHED PROCEDURE AND USED THE FIBER INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24250883 ↗MalfunctionFeb 3, 2026Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVER TOUCH DIRECT PROCEDURE KIT. DURING THE EVLT PROCEDURE, THE FIBER FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. IT WAS NOT ORIGINALLY NOTICED BY THE PHYSICIAN THAT THE TIP HAD FRACTURED OFF INSIDE OF THE PATIENT. THE PATIENT LATER PRESENTED WITH SIGNIFICANT HYPEREMIA IN HER THIGH. THE PHYSICIAN MADE AN INCISION, WHERE THE FIBER FRAGMENT WAS FOUND AND REMOVED. THE PHYSICIAN REPORTED THAT HE HAD FOLLOWED THE ESTABLISHED PROCEDURE AND USED THE FIBER INTRODUCER. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24250881 ↗MalfunctionOct 21, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHEN HANDLING THE FIBER DURING INTRODUCTION, THE FIBER BROKE IN HALF. HALF OF THE FIBER WAS INSIDE THE PATIENT AND THE OTHER HALF WAS STILL CONNECTED TO THE UNIT. THE RETAINED FRAGMENT WAS STICKING FAR ENOUGH OUT OF THE PATIENT, THE PROVIDER WAS ABLE TO PULL IT OUT WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348298 ↗MalfunctionSep 17, 2025Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. PHYSICIAN PULLED THE LASER FIBER THROUGH THE SHORT ACCESS SHEATH. HE THEN TRIED TO REMOVE THE SHEATH TO CONTINUE THE PROCEDURE, BUT THE SHEATH BROKE NEAR THE HUB. ROUGHLY 8CM OF THE SHEATH REMAINED IN THE PATIENT. THE DOCTOR SUCCESSFULLY REMOVED THE BROKEN SHEATH FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. IT WAS REPORTED THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23074319 ↗MalfunctionSep 2, 2025Fracture; Fracture
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH DIRECT PROCEDURE KIT. DURING THE PROCEDURE, WITH ABOUT 25CM LEFT TO FINISH THE SAPHENE VEIN OF THE RIGHT LEG, THE FIBER BROKE. THE DOCTOR WASN'T FORCING, SHE WAS PERFORMING THE PROCEDURE AS INSTRUCTED. THE PATIENT HAD NO TORTUOSITY IN THIS REGION OF THE LEG. WHEN THE FIBER BROKE, THE TIP OF THE FIBER WAS LEFT OUTSIDE THE INTRODUCER, MAKING IT EASIER TO REMOVE. THEY OPENED A 2ND FIBER TO FINISH THE REMAINING 25CM, AND PERFORMED THE ABLATION ON THE LEFT LEG.
Patient problems: Foreign Body In Patient
MAUDE report 22943689 ↗MalfunctionSep 2, 2025Fracture; Fracture
EVENT DESCRIPTION CORRECTION: AN FDA MEDSUN PROGRAM REPORT WAS RECEIVED VIA EMAIL WHICH REPORTED THAT AN END-USER FACILITY EXPERIENCED AN ISSUE WITH A "NEVERTOUCH 45CM KIT W/GRIPPER AND RFID T' DEVICE. DURING A PATIENT'S RIGHT ACCESSORY SAPHENOUS VEIN ENDOVENOUS LASER ABLATION (EVLA) PROCEDURE, THE FIBER FRACTURED INSIDE OF THE PATIENT. THE DEVICE FRAGMENT WAS REMOVED VIA A CUT-DOWN/SNARE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE FRACTURED FIBER BURNED A HOLE THROUGH THE STERILE DRAPES ON THE STERILE FIELD AFTER IT HAD BEEN REMOVED FROM THE PATIENT. THE END-USER REPORTED THAT ALL SAFETY MEASURES WERE BEING FOLLOWING PER PROTOCOL PRIOR TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22942935 ↗MalfunctionAug 13, 2025Fracture; Use of Device Problem
FROM STAFF: LASER FIBER BEING USED IN ABLATION CASE WAS FRACTURED AND BURNED A HOLE THROUGH THE STERILE DRAPES ON THE FIELD. PRIOR TO ALL SAFETY MEASURES WERE BEING FOLLOWED PER PROTOCOL. THE EVENT HAPPENED DUE TO A FAULTY PRODUCT AND COULD NOT HAVE BEEN PREDICTED DUE TO THE NATURE OF THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792212 ↗MalfunctionAug 4, 2025Fracture; Flare or Flash; Fracture; Flare or Flash
AN END USER REPORTED AN ISSUE WITH AN EVLT FIBER AND A VENACURE 1470 LASER UNIT . IT WAS REPORTED THE LASER UNIT BURNED THE FIBER OFF AT THE GRIPPER SECTION (FRS GRIPPER HAD CAUGHT FIRE). THE FIBER WAS INSIDE THE PATIENT AT THE TIME, AND WAS SUBSEQUENTLY REMOVED. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. THEY REQUESTED TO HAVE THE UNIT RETURNED FOR EVALUATION AND PM/CALIBRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701062 ↗MalfunctionJul 9, 2025Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PVAK -- 400 MICRON FIBER PROCEDURE KIT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE FIBER FRACTURED OFF INSIDE THE PATIENT WHERE IT IS RETAINED. THE PROCEDURE HAD BEEN COMPLETED WITH THE FIBER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22461873 ↗MalfunctionJul 9, 2025Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE FIBER WAS CONNECTED TO THE UNIT. WHEN IT WAS TURNED ON, THE MIDDLE SPLIT AND HEAT WAS EMITTING FROM THE SPLIT, BURNING ONE OF THE TOWELS. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461860 ↗MalfunctionJun 23, 2025Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH AN EVLT LASER FIBER. IT WAS REPORTED THE PROCEDURE WAS PERFORMED ON (B)(6). 1 WEEK POST PROCEDURE , IT WAS FOUND ON A FOLLOW UP ULTRASOUND THAT A PORTION OF THE FIBER HAD DETACHED AND WAS RETAINED INSIDE THE PATIENT. THE RETAINED FRAGMENT WAS RETRIEVED TWO DAYS LATER VIA A SMALL CUT DOWN ON THE GREAT SAPHENOUS VEIN AT THE KNEE AND THEN PULLED OUT THE FRAGMENT USING CLAMPS.
Patient problems: Foreign Body In Patient
MAUDE report 22308174 ↗MalfunctionApr 28, 2025Melted; Melted
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PVAK -- 400 MICRON FIBER PROCEDURE KIT. AFTER THE LASER FIBER WAS HOOKED UP TO THE MACHINE, PRIOR TO USING IT ON THE PATIENT, THE DOCTOR ACTIVATED THE LASER ON THE FLOOR OUTSIDE THE PATIENT TO MAKE SURE THAT IT WAS ON AND VISIBLE SMOKE CAME OUT OF THE TIP OF THE LASER. WHEN INSPECTING THE FIBER, IT WAS NOTED THE FIBER LOOKED LIKE IT WAS MELTING. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917300 ↗
Other Angiodynamics, Inc. products
- Soft-Vu54 models · 66 reports · 18 recalls
- Mini Stick MAX12 models · 2 reports · 12 recalls
- Smart Port CT36 models · 479 reports
- AccuVu9 models · 14 reports · 4 recalls
- DuraMax8 models · 23 reports · 3 recalls
- Solero4 models · 154 reports
- DuraFlow6 models · 8 reports · 2 recalls
- NanoKnife9 models · 44 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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