VenaCure EVLT EVLT/PVAKRecalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI H787EVLTPVAK0), received between May 11, 2016 and May 6, 2026 — classified as 3 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Fracture” (79 reports).

1 other recall cover devices cleared under the same FDA submission (K041957); 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 25 most recent of 123 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 28, 2025Detachment of Device or Device Component; 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. DURING PREPARATION FOR THE EVLT PROCEDURE, NO DAMAGE WAS NOTED REGARDING THE CONTAINER OR FIBER TIP. THE TIP WAS CONFIRMED TO BE ATTACHED PRIOR TO INSERTION INTO THE NEEDLE AND THE PERFORATOR. THE FIBER WAS INSERTED INTO THE NEEDLE AFTER GAINING ACCESS TO THE VEIN AND IN THE PROPER POSITION AND USED FOR 1 SECOND, EMITTING 9.6 JOULES. 125CC TUMESCENT ANESTHESIA USED DURING PROCEDURE. AT THE PROCEDURE CLOSURE, THE FIBER AND NEEDLE WERE REMOVED AS ONE UNIT, STILL CONNECTED VIA THE TWIST LOCK. WHEN IT WAS WITHDRAWN, IT WAS NOTED THE TIP OF THE FIBER HAD DETACHED INSIDE OF THE PATIENT. THE FIBER HAD BEEN ONLY USED FOR ONE PROCEDURE. THE FIBER TIP WAS LEFT IN-SITU AND THE PATIENT WILL BE RETURNING MONDAY (B)(6) 2024 FOR A CHECK.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21917299 ↗
• MalfunctionAug 7, 2024Detachment of Device or Device Component; 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. AFTER THE DOCTOR ACCESSED THE PERFORATOR VEIN, THE FIBER WAS INSERTED AND THEN THE OTHER END WAS HANDED TO THE MEDICAL ASSISTANT TO PLUG IN. AT THIS TIME, THE FIBER BROKE INTO TWO PIECES. THE DEVICE WAS REMOVED AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. NO FIBER FRAGMENTS REMAINED INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928875 ↗
• MalfunctionJul 10, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A FIBER FROM A PVAK -- 400 MICRON FIBER PROCEDURE KIT. DURING A PROCEDURE, AFTER THE FIBER WAS INSERTED INTO THE PATIENT, THE FOOT PEDAL WAS DEPRESSED TO POWER ON THE LASER; HOWEVER, THE USUAL BUBBLING THAT IS SEEN ON ULTRASOUND WAS NOT PRESENT. THE FIBER WAS REMOVED FROM THE PATIENT AND FOUND TO BE FRACTURED OFF AT THE GRIPPER JUNCTION. NO FRAGMENTS WERE LEFT IN THE PATIENT AND NO ADVERSE EFFECTS OR HARM WAS EXPERIENCED. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE BECAUSE TUMESCENCE HAD ALREADY BEEN INJECTED, MAKING IT IMPOSSIBLE TO PLACE A NEW FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716652 ↗
• MalfunctionMar 25, 2024Fracture; Fracture

  A NURSE PRACTITIONER REPORTED RECEIVING A PVAK -- 400 MICRON FIBER PROCEDURE KIT THAT CONTAINED A FRACTURED 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 18968243 ↗
• MalfunctionMar 14, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON FIBER PROCEDURE KIT. DURING PREPARATION, THE FIBER WAS FOUND TO BE BROKEN AT THE DISTAL END, CLOSER TO THE TIP. ULTIMATELY, 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 18903857 ↗
• MalfunctionFeb 1, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING, 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 18621519 ↗
• MalfunctionJan 4, 2024Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING, 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 18444416 ↗
• MalfunctionDec 28, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING, 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 18409662 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  A MEDICAL ASSISTANT REPORTED AN ISSUE WITH A PVAK, 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING THE DEVICE, THE PHYSICIAN DISCOVERED THAT THE FIBER WAS 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 18348086 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING, THE FIBER WAS FOUND TO BE FRACTURED. 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 18348063 ↗
• MalfunctionDec 18, 2023Sparking; Sparking

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON FIBER PROCEDURE KIT. TWENTY SECONDS INTO THE INITIAL FIRING OF THE FIBER, IT BEGAN POPPING AND SPARKING, APPROXIMATELY 7 INCHES FROM THE TIP. THE FIBER WAS INSPECTED, PRIOR TO USE, AND THERE WAS NO VISIBLE DAMAGE NOTED. THE PORTION OF THE LASER, WHERE THIS OCCURRED, WAS NOT INSIDE THE PATIENT AT THE TIME OF THE POPPING AND SPARKING. THE GENERATOR WAS SET AT 7W AND NO ERROR MESSAGES OCCURRED. THE OPERATOR EXPERIENCED A SMALL, SUPERFICIAL BURN ON THEIR FINGER; HOWEVER, THEY DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348055 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  A MEDICAL ASSISTANT RETURNED AN UNKNOWN/ UNLABELED PVAK FIBER. WHILE UNPACKING THE DEVICE, THE FIBER WAS FOUND TO BE FRACTURED. FURTHER FOLLOW UP DETERMINED THAT THIS DEVICE WAS FOUND TO BE FRACTURED WHILE UNPACKING, DURING PREPARATION FOR A PROCEDURE. 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 18348036 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING A PROCEDURE, THE FIBER BROKE (COMPLETE DETACHMENT) JUST ABOVE THE COMPRESSION CLAMP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE ISSUE OCCURRED OUTSIDE OF THE PATIENT; THEREFORE, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE FIBER WAS INSPECTED PRIOR TO USE AND DID NOT SHOW ANY SIGNS OF A DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256664 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  A MEDICAL ASSISTANT REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. IT WAS REPORTED THAT THE FIBER WAS FOUND TO BE BENT, UPON OPENING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256654 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  A MEDICAL ASSISTANT REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING THE DEVICE, THE CLEAR FIBER TIP WAS FOUND TO BE MISSING. IT WAS NOT FOUND WITHIN THE PACKAGING. 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 18256653 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING THE DEVICE, THE TIP WAS FOUND TO HAVE DETACHED FROM 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 18256646 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. WHILE UNPACKING THE DEVICE, THE DOCTOR DISCOVERED THAT THE FIBER WAS BROKEN. 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 18256645 ↗
• MalfunctionDec 4, 2023Component Missing; Component Missing

  A NURSE PRACTITIONER REPORTED THE FOLLOWING ISSUE WITH A PVAK -- 400 MICRON FIBER PROCEDURE KIT: WHEN OPENING A PROCEDURE KIT, IT WAS NOTED THE CLEAR END OF THE LASSER WAS MISSING. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS OPENED IN ORDER TO CONTINUE WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256641 ↗
• MalfunctionDec 4, 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 "BENT, LOOKING ALMOST BROKEN, NEAR THE CONNECTOR." THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO EVIDENT DAMAGE TO THE PACKAGING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256638 ↗
• MalfunctionDec 4, 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 BROKEN IN TWO PIECES. 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 18256637 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A PVAK -- 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT. DURING PROCEDURE PREPARATION, THE FIBER BROKE WHEN THE PHYSICIAN WAS TRYING TO UNTIE THE PLASTIC TWIST HOLDING THE LASER FIBER IN THE SPOOL. THE 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 18256635 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041957. One submission often covers many models, so check the product and lot details in each record.

• Z-1819-2022 · Aug 10, 2022 · Open, Classified
  VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.