VenaCure EVLT EVLTPVAKUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI H787EVLTPVAKUS0), received between Sep 16, 2020 and Oct 21, 2025 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• 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 ↗
• 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 ↗
• MalfunctionApr 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A MEDICAL ASSISTANT REPORTED THAT THE TIP OF THE PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT DETACHED INSIDE OF THE PATIENT'S LEG., DURING A PROCEDURE. THE FOLLOWING PROCEDURE INFORMATION WAS PROVIDED: PART 1 - RIGHT POSTERIOR THIGH, CRANIAL THIGH EXTENSION. TIP WAS CHECKED BEFORE AND PRESENT AFTER COMPLETION. FIBER WAS USED FOR 11 SECONDS AND EMITTED 69 JOULES OF HEAT. PART 2 - RIGHT LATERAL CALF PERFORATOR AT THE HEIGHT OF 37 CENTIMETERS. TIP WAS NOT PRESENT FOLLOWING INSERTION AND USE IN VEIN. FIBER WAS USED FOR 5 SECONDS AND EMITTED 28.7 JOULES OF HEAT. A FOLLOW UP ULTRASOUND WAS PERFORMED, APPROXIMATELY ONE WEEK AFTER THE PROCEDURE, AND THE TIP HAS REMAINED IN THE SAME POSITION; THEREFORE, IT WILL BE LEFT IN SITU. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21774932 ↗
• InjuryDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. THE DOCTOR PERFORMED A PERFORATOR PROCEDURE ON (B)(6) 2024 WITH NO REPORTED ISSUES. WHEN THE PATIENT RETURNED ON (B)(6) 2024, FOR POST-TREATMENT FOLLOW UP, THEY COMPLAINED OF PAIN IN THE ARE WHERE THE PROCEDURE HAD BEEN PERFORMED. THIS AREA WAS EXAMINED WITH ULTRASOUND AND IT WAS IMMEDIATELY APPARENT THAT A PORTION OF THE LASER FIBER HAD BROKEN OFF AND WAS RETAINED IN THE VEIN. THE DOCTOR REMOVED 2.7 CM SEGMENT OF THE DISTAL LASER FIBER, BY MAKING A SMALL INCISION IN THE PATIENT'S LEG. SEVERAL DAYS AFTER THE FRAGMENT WAS REMOVED, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN INFECTION IN THEIR LEG. IN THE HOSPITAL, THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Bacterial Infection; Foreign Body In Patient

  MAUDE report 20909561 ↗
• MalfunctionJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING A PROCEDURE ON A PATIENT'S GSV, THE FIBER BROKE INSIDE THE VESSEL. THE FIBER WAS REMOVED; HOWEVER, THE BROKEN PORTION OF THE FIBER STAYED INSIDE THE PATIENT. THE PATIENT RETURNED, THE SAME DAY, FOR AN ADDITIONAL PROCEDURE TO REMOVE THE BROKEN FIBER, FROM THE PATIENT'S VESSEL. THE BROKEN PIECE WAS 8CM LONG. THE PATIENT IS EXPERIENCING POST SURGICAL PAIN AND SWELLING. DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS WERE OBTAINED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19652388 ↗
• MalfunctionMar 19, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A MEDICAL ASSISTANT REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. IT WAS REPORTED THAT THE CLEAR TIP IS SHORTER [TIP DETACHED] THAN OTHER FIBERS THE ACCOUNT HAS PREVIOUSLY USED AND THERE WERE NO OTHER ABNORMALITIES NOTED WITH THE DEVICE. THE DEVICE WAS NOT USED ON A PATIENT; THEREFORE, THERE WAS NO HARM OR ADVERSE PATIENT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933071 ↗
• MalfunctionMar 14, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING PREPARATION, THE FIBER TIP WAS FOUND TO BE MISSING THE "WHITE PART." THE BLUE COATING EXTENDED ALL THE WAY TO THE END OF THE FIBER. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909536 ↗
• MalfunctionMar 12, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH TWO PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KITS. WHILE UNPACKING, THE FIBERS WERE FOUND TO BE DAMAGED AT THE TIP. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. DEVICE 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891508 ↗
• MalfunctionMar 12, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH TWO PVAK: 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KITS. WHILE UNPACKING, THE FIBERS WERE FOUND TO BE DAMAGED AT THE TIP. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. DEVICE 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891476 ↗
• MalfunctionMar 8, 2024Fracture; Fracture

  A PHYSICIAN REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING INTRODUCTION, THE PHYSICIAN NOTICED THE FIBER HAD A CRACK IN IT, APPROXIMATELY 10-15 CM FROM THE TIP, AND A RED LIGHT WAS BEING EMITTED FROM THE CRACK. THE PHYSICIAN BEGAN TO LOOK AT THE PARTIAL FRACTURE MORE CLOSELY AND, IN THE PROCESS, COMPLETELY FRACTURED THE FIBER. THIS FIBER NEVER WENT INSIDE THE PATIENT. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866086 ↗
• MalfunctionMar 4, 2024Fracture; Device Damaged Prior to Use; Detachment of Device or Device Component; Fracture; Device Damaged Prior to Use; Detachment of Device or Device Component

  A MEDICAL ASSISTANT REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. IT WAS REPORTED THAT THE KIT CONTAINED ONLY BLUE COATING AT THE TIP, WITHOUT AN INTERNAL, CLEAR FIBER. THIS WAS DISCOVERED WHILE UNPACKING THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825296 ↗
• MalfunctionMar 4, 2024Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  A MEDICAL ASSISTANT REPORTED RECEIVING A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT THAT CONTAIN A BENT/BROKEN FIBER. THIS WAS DISCOVERED WHILE UNPACKING THE DEVICE. THERE WAS NO PATIENT ADVERSE EFFECTS, HARM, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825088 ↗
• MalfunctionFeb 28, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNWRAPPING THE FIBER, PRIOR TO A PROCEDURE, THE CLEAR PACKAGING WAS DIFFICULT TO REMOVE. ULTIMATELY, THE FIBER FRACTURED WHILE THE END USER TRIED REMOVING THE "CLEAR TUBING" PACKAGE. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799473 ↗
• MalfunctionFeb 28, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING THE KIT, THE FIBER WAS FOUND TO BE FRACTURED. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799359 ↗
• MalfunctionFeb 23, 2024Thermal Decomposition of Device; Fire; Melted; Overheating of Device; Detachment of Device or Device Component; Thermal Decomposition of Device; Fire; Melted; Overheating of Device; Detachment of Device or Device Component

  A PHYSICIAN REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHEN THE PHYSICIAN STARTED THE PROCEDURE BY PRESSING ON THE FOOT PEDAL, AN ACTIVE FLAME WAS NOTED AT THE FIBER STRAIN RELIEF, COMING OFF THE HUB. THE PHYSICIAN IMMEDIATELY STOPPED THE PROCEDURE AND HAD TO BLOW OUT THE FLAME. IT WAS REPORTED THAT THE FIBER SEEMED TO HAVE MELTED AND THEN DETACHED FROM THE HUB. THE ACCOUNT WAS UNABLE TO PROVIDE THE SPECIFIC SETTINGS USED ON THE GENERATOR BUT NOTED THAT THEY UTILIZE 'STANDARD SETTINGS.' THERE WAS NO INJURY SUSTAINED BY THE PATIENT OR PROVIDERS AND THE REMAINING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766478 ↗
• MalfunctionFeb 6, 2024Fracture; Fracture

  A MEDICAL ASSISTANT RETURNED AN UNKNOWN/ UNLABELED PVAK FIBER THAT WAS FOUND TO BE FRACTURED. MULTIPLE GOOD FAITH EFFORT ATTEMPTS HAVE BEEN PERFORMED TO OBTAIN ADDITIONAL DETAILS REGARDING THIS DEVICE; HOWEVER, NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 18652792 ↗
• MalfunctionJan 15, 2024Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; 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. THE FIBER WAS FOUND BROKEN UPON OPENING, UNUSED. 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 18510543 ↗
• MalfunctionJan 15, 2024Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; 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 REMOVING THE FIBER FROM THE PACKAGING, IT WAS OBSERVED THE FIBER WAS BENT/BROKEN. THE DEVICE WAS SET ASIDE AND 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 18510541 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING THE DEVICE, THE FIBER WAS FOUND TO BE FRACTURED INTO TWO SEPARATE PIECES. THERE WAS NO DAMAGE NOTED TO THE INTERNAL OR EXTERNAL PACKAGING OF THE DEVICE. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18032184 ↗
• MalfunctionDec 29, 2022Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING PREPARATION, THE KIT WAS OPENED AND THE FIBER WAS FOUND TO BE BROKEN INTO TWO PIECES.  THERE WAS NO DAMAGE NOTED TO THE INTERNAL OR EXTERNAL PACKAGING OF THE DEVICE.  THE FOLLOWING PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068763 ↗
• MalfunctionDec 17, 2020Fracture; Fracture

  AN END USER REPORTED RECEIVING AN EVLT FIBER THAT WAS BROKEN UPON OPENING THE BOX. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028923 ↗
• InjuryNov 10, 2020Fracture; Fracture

  A PRACTICE MANAGER REPORTED AN ISSUE WITH A PVAK --400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING A PROCEDURE, THE CATHETER WAS INSERTED EASILY THROUGH THE SHEATH, WITHOUT RESISTANCE. THIS OCCURRED 3CM FROM SFJ AND THE LASER TIP AND SHEATH WAS IDENTIFIED 1CM BACK FROM THE LASER. WITH STANDARD HEATING OF 7W, THE DOCTOR BEGAN TO PULL BACK AND NOTED THAT THE TIP WAS NOT MOVING. THE SHEATH/LASER WAS REMOVED; HOWEVER, APPROXIMATELY 3CM OF THE SHEATH/LASER REMAINED IN THE PATIENT'S LEFT AAGSV. 911 WAS THEN CALLED AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR EMERGENCY SURGERY. THE COMPONENT WAS REMOVED UNDER ANESTHESIA, VIA AN INCISION IN THE PATIENT'S GROIN AND WAS HOSPITALIZED FOR ONE DAY. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10818043 ↗
• MalfunctionNov 10, 2020Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION. DURING UNPACKING, THE CUSTOMER NOTED THAT THE CATHETER WAS BROKEN. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED BY THE END USER. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10815792 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  AN END USER REPORTED DISCOVERING A CRACK IN THE LASER FIBER, UPON UNPACKING A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10705276 ↗
• MalfunctionSep 16, 2020Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EVLT LASER FIBER. AFTER THE PATIENT WAS PREPPED, THE LASER FIBER WAS OPENED AND UNWRAPPED WHEN IT WAS FOUND TO BE DENTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WAS NO REPORTED OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10541665 ↗