VenaCure EVLT 11403013Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI H787114030130), received between Aug 10, 2016 and Mar 24, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K112600, K162914, K171921, K231945); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A 65CM NEVERTOUCH FRS .018 PROCEDURE KIT. DURING A PROCEDURE, THE PATIENT'S LEFT GSV AND SSV WAS COMPLETED SUCCESSFULLY AT THE FOLLOWING: LEFT SHORT VEIN 10W/80J 1208J/120 SECONDS AND LEFT LONG VEIN 10W/70J 1406J/140 SECONDS. THE SURGEON THEN MADE AN INCISION WITH BLADE INTO THE RIGHT SSV. THE SURGEON PUNCTURED WITH A 21G NEEDLE AND INSERTED THE 0.18" GUIDEWIRE AS NORMAL TO THE JUNCTION WITH THE POPLITEAL VEIN. THE SURGEON THEN TRIED TO ADVANCE THE SHEATH WITH THE INTRODUCER INSIDE, OVER THE GUIDEWIRE AND THROUGH THE SKIN; HOWEVER, THE INTRODUCER BUCKLED ON THE GUIDEWIRE, SO A LARGER INCISION WAS MADE. THE SURGEON TRIED AGAIN AND THE SHEATH WITH THE INTRODUCER WOULD NOT ADVANCE; THEREFORE, THE DECISION WAS MADE TO ABORT THE PROCEDURE AND THE SURGEON PULLED OUT THE SHEATH, INTRODUCE AND GUIDEWIRE, NOTING SOME RESISTANCE. ON CHECKING THE SSV AGAIN WITH ULTRASOUND, THE SURGEON NOTICED THERE WAS GUIDEWIRE STILL IN THE PATIENT'S VEIN. THE SURGEON AND SCRUB NURSE THEN NOTICED THAT HALF THE ORIGINAL GUIDEWIRE WAS NOT IN FULL ON THE SCRUB TROLLEY. THE SURGEON TIED OFF THE SSV AND PERFORMED A CUT DOWN, USING ULTRASOUND AND FORCEPS, AND REMOVED 47CM OF GU

  Patient problems: Foreign Body In Patient

  MAUDE report 21676704 ↗
• MalfunctionApr 5, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A GUIDEWIRE FROM A 65CM NEVERTOUCH FRS .018 PROCEDURE KIT. THE SURGEON PUNCTURED THE PATIENT'S VEIN AND INSERTED THE GUIDEWIRE IN THE USUAL WAY. HE STRUGGLED TO ADVANCE THE GUIDEWIRE AFTER A FEW CM'S AND NOTICED SOMETHING UNUSUAL ON ULTRASOUND. HE TOOK OUT THE ACCESS NEEDLE AND SLOWLY RETRACTED THE GUIDEWIRE AND AS HE DID, HE NOTICED THE WIRE HAD UNRAVELED. THE SURGEON NOTICED 1CM OF THE END OF THE WIRE HAD SNAPPED OFF AND WAS AT THE ENTRY POINT ON THE LEG. HE REMOVED THIS WITH SOME FORCEPS. THE SURGEON DECIDED TO START AGAIN WITH A DIFFERENT VENACURE EVLT PROCEDURE KIT, AND COMPLETED THE PROCEDURE WITH NO FURTHER INCIDENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16683953 ↗
• MalfunctionMay 6, 2022Fracture; Fracture

  DURING AN EVLT PROCEDURE, IT WAS DETERMINED THAT THE LASER FIBER HAD A BREAK WHERE THE FIBER WAS RESTRAINED WITH A CLAMP. PRIOR TO THE CASE, THE CLINICAL SPECIALIST (CS) HAD LOOKED AT THIS CLAMP RESTRAINT AND OBSERVED THAT THE FIBER WAS NOT TOUCHED BY THE CLAMP, JUST ENCIRCLED. AFTER THE BREAK WAS DISCOVERED, IT WAS NOTED THAT THE FIBER HAD MIGRATED INTO A SMALL V-SHAPE, FORMED BY THE CLAMP NOT BEING FULLY CLOSED. THE CS FEELS THAT THE FIBER HAD BEEN PULLED AGAINST, CAUSING IT TO BECOME TRAPPED IN THAT V, OR HAD BEEN INADVERTENTLY CLAMPED THEN RELEASED. ULTIMATELY, 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 14309847 ↗
• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A 65CM NEVERTOUCH FRS .018 PROCEDURE KIT. IT WAS REPORTED THAT THE "TIP BROKE OFF" DURING THE PROCEDURE. THE LASER CATHETER WAS REMOVED AND THEN NOTICED BROKEN TIP ON THE STERILE FIELD. THE TIP HAD REMAINED INSIDE THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648316 ↗
• MalfunctionDec 10, 2019Fracture; Fracture

  AS REPORTED: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS KINKED/FRACTURED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT AS THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9446222 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

  AS REPORTED: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER HAD A SHARP ANGULATION (BENT/FRACTURED) THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT AS THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376000 ↗
• MalfunctionApr 2, 2019Fracture; Fracture

  DURING AN EVLT PROCEDURE, WHEN THE TREATING PHYSICIAN PULLED THE LASER FIBER BACK THROUGH THE TRE-SHEATH, THE TIP OF THE FIBER FRACTURED OFF THE FIBER SHAFT AND REMAINED LODGED IN THE TRE-SHEATH. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THERE WAS NO HARM TO THE PATIENT AS THE TIP REMAINED INSIDE OF THE TRE-SHEATH. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474749 ↗
• InjuryJan 30, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD BILATERAL SHORT SAPHENOUS VEIN INCOMPETENCE AND THE PLAN WAS TO PERFORM BILATERAL EVLT OF HER SHORT SAPHENOUS VEINS. THE RIGHT SHORT SAPHENOUS VEIN (31 CM) WAS TREATED FIRST WHICH WAS UNEVENTFUL. THE LEFT SHORT SAPHENOUS VEIN WAS THEN CANNULATED AND THE CATHETER WAS APPROPRIATELY POSITIONED (28 CM LENGTH TO BE TREATED). THE LASER FIBRE WAS THEN INTRODUCED AND LOCKED INTO THE CATHETER. TUMESCENCE WAS GIVEN AND THEN THE LASER WAS ACTIVATED BUT AS THE CATHETER WAS PULLED OUT IT BECAME OBVIOUS THAT THE CATHETER WAS INCOMPLETE WITH 20 CM LENGTH FROM THE TIP REMAINING IN THE PATIENT'S VEIN. THE LASER FIBRE WAS WITH THE PART OF THE CATHETER THAT CAME OUT OF THE PATIENT. WE CONFIRMED THE PRESENCE OF THE REMAINING PART OF THE CATHETER IN THE PATIENT'S SHORT SAPHENOUS VEIN, PERFORMED A CUT DOWN INTO THE VEIN AND SURGICALLY REMOVED THE 20 CM LENGTH OF THE CATHETER. THE HARM THAT OCCURRED WAS THE SURGICAL CUT DOWN TO RECOVER THE CATHETER AND ALSO THAT THE SHORT SAPHENOUS VEIN WASN'T ADEQUATELY TREATED NECESSITATING ANOTHER TREATMENT IN THE FUTURE WHICH WE ARE PLANNING TO UNDERTAKE LATER ON. ON INSPECTION OF THE KIT IT WAS APPARENT THAT THE CAUSE OF THE PROBLEM WAS THE LOCKING S

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8288999 ↗
• MalfunctionJul 2, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: AT THE START OF AN EVLT PROCEDURE, AFTER THE LASER FIBER HAD BEEN CONNECTED TO THE LASER UNIT, THE FIBER REGISTERED AS "INVALID FIBER" ON THE UNIT'S DISPLAY. WHEN IT WAS DISCONNECTED AND EXAMINED BY THE USER, IT APPEARED TO BE CRACKED/FRACTURED NEAR THE HANDLE/GRIPPER. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH A NEW OF HTE SAME DEVICE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS EVENT AS THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656093 ↗
• MalfunctionMay 16, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED TO ANGIODYNAMICS ON APRIL 17, 2018: UPON WITHDRAWING THE LASER FIBER DURING AN EVLT PROCEDURE, IT WAS NOTED THE FIBER TIP HAD MELTED THE SHEATH. THE CUSTOMER SAID THE LUER LOCK DID NOT COME LOOSE AND THE LASER WAS HUBBED TO THE CATHETER. NO PIECE OF THE SHEATH HAD MELTED OFF. THERE WAS NO PATIENT IMPACT TO THE PATIENT AS THIS OCCURRED OUTSIDE OF THE PATIENT. IT WAS INDICATED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518023 ↗
• MalfunctionApr 10, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: A PATIENT PRESENTED FOR AN ENDOVENOUS LASER TREATMENT PROCEDURE. BEFORE THE DOCTOR PUT THE LASER IN THE CATHETER, HE NOTICED A BREAK AND RED LIGHT APPEARING THROUGH THE MIDDLE. THE DEFECT WAS NOTED PRIOR TO PLACEMENT INTO THE PATIENT. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7411786 ↗
• MalfunctionNov 29, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING AN EVLT PROCEDURE, THE PHYSICIAN TREATED THE PATIENT'S RIGHT GSV WITH NO REPORT OF DEVICE MALFUNCTION OR PATIENT COMPLICATIONS. THE LASER FIBER WAS WITHDRAWN IN ORDER TO TREAT THE PATIENT'S AAGSV. THE FIBER WAS INSERTED INTO THE PATIENT AND THE PHYSICIAN TIGHTENED THE LUER LOCK AS PER NORMAL PROCEDURE. VIA ULTRASOUND, IT WAS NOTED THE TIP OF THE CATHETER WAS NOT EXTENDING FROM THE TIP OF THE SHEATH AS PER NORMAL. THE PHYSICIAN PROCEEDED TO CONTINUE WITH THE PROCEDURE, AND FIRED THE LASER FIBER. OUTSIDE OF THE PATIENT'S BODY, THE SHEATH WAS NOTED TO BE "SMOKING" AND APPEARED TO BE MELTED. THE PHYSICIAN REMOVED THE ENTIRE DEVICE FROM THE PATIENT. NO ENERGY HAD BEEN APPLIED TO THE PATIENT'S AAGSV. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7067997 ↗
• MalfunctionSep 21, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON AUGUST 30, 2017: DURING AN EVLT PROCEDURE, IT WAS NOTED THE FIBER STOP DETACHED FROM THE LASER FIBER SHAFT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN FOR EVALUATION BY THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882539 ↗
• MalfunctionJan 11, 2017Uncoiled; Uncoiled

  AS REPORTED ON (B)(6) 2016, DURING AN EVLT PROCEDURE , THE TREATING PHYSICIAN HAD ALREADY ACCESSED THE GSV VEIN AND WAS ATTEMPTING TO THREAD THE GUIDEWIRE THROUGH THE VEIN. WHILE WITHDRAWING THE GUIDEWIRE DUE TO DIFFICULTY ADVANCING, IT UNCOILED AS THE PHYSICIAN PULLED THE WIRE OUT FROM THE NEEDLE. THE GUIDEWIRE WAS REMOVED WITHOUT ANY FRAGMENTS LEFT INSIDE OF THE PATIENT. IT WAS SET ASIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW OF THE SAME DEVICE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6242051 ↗
• MalfunctionAug 10, 2016Failure to Deliver Energy; Fracture; Failure to Fire; Failure to Deliver Energy; Fracture; Failure to Fire

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. AT THE START OF THE PROCEDURE, IT WAS NOTED THE LASER FIBER APPEARED TO HAVE A CRACK NEAR THE CONNECTOR HUB. THE AIMING BEAM GLOWED BRIEFLY, BUT THEN DISAPPEARED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THIS EVENT. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5866400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112600, K162914, K171921, K231945. One submission often covers many models, so check the product and lot details in each record.

• Z-2444-2019 · Jun 27, 2019 · Terminated
  AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012