VenaCure EVLT EVLT/55-OPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI H787EVLT55OPS0), received between May 17, 2016 and Mar 31, 2023 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fracture” (25 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Fracture; Fracture

  AN END USER EXPERIENCED AN ISSUE WHEN USING A FIBER FROM A EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM KIT. WHEN THEY OPENED THE PACKAGE, IT WAS NOTICED THE FIBER WAS DEFECTIVE (FRACTURED). A NEW OF THE SAME KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED. 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 16654894 ↗
• MalfunctionMar 14, 2023Fracture; Fracture

  AN END USER EXPERIENCED AN ISSUE WHEN USING A FIBER FROM AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM KIT. WHILE "THREADING THE FIBER" TO TREAT A PATIENT WITH THE OPS FIBER, THE FIBER FRACTURED. THE FIBER WAS NOT IN THE PATIENT LEG AT THE TIME OF THE FIBER FRACTURE. THE DEVICE WAS REPLACED WITH A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 16538009 ↗
• MalfunctionOct 19, 2022Fracture; Fracture

  A PHYSICIAN REPORTED AN ISSUE WITH A FIBER FROM AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM. DURING A PROCEDURE, A SECTION OF THE FIBER, THAT WAS LOCATED OUTSIDE OF THE PATIENT, SNAPPED WHILE EMITTING LASER ENERGY. THE FRACTURE WAS CLOSER TO THE HUB THAN THE TIP OF THE FIBER. THE FIBER WAS REMOVED AND A NEW OPS LASER FIBER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633232 ↗
• MalfunctionJul 28, 2022Fracture; Melted; Fracture; Melted

  AN END USER REPORTED AN ISSUE WITH AN EVLT KIT, WITH SPOTLIGHT OPS SHEATH 55CM. THE USER REPORTED THAT THE MARKINGS ON THE FIBER WERE PRINTED WRONG, AND REPORTEDLY, TOO CLOSE TO THE FIBER TIP, RESULTING IN THE TIP NOT COMING OUT OF THE SHEATH WHEN LOCKING IN THE FIBER AT THE BLACK MARKINGS. DURING THE PROCEDURE, THE SHEATH BURNED/MELTED WHILE INSIDE THE PATIENT. THE FIBER AND SHEATH WERE REMOVED WITH NO ISSUES, AND WHEN EXAMINED , IT APPEARED THE FIBER WAS BENT/KINKED AT THE SAME LOCATION OF THE SHEATH BURN/MELT. THE DEVICES WERE REPLACED WITH NEW OF THE SAME AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. POST PROCEDURE, THE PATIENT HAD AN ULTRASOUND, AT WHICH TIME NO FRAGMENTS WERE NOTES. A SECOND ULTRASOUND WAS PERFORMED THE NEXT DAY, AND AGAIN NO FRAGMENTS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120902 ↗
• MalfunctionOct 19, 2021Fracture; Fracture

  A PHYSICIAN REPORTED AN ISSUE WITH AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM. WHILE UNPACKING THE FIBER, IT WAS NOTED THAT IT APPEARED TO BE BENT AT A 90 DEGREE ANGLE. WHEN THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE DEVICE, IT BROKE IMMEDIATELY. THE PATIENT WAS ON THE TABLE WHEN THIS OCCURRED; HOWEVER, THERE WAS NO SIGNIFICANT DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657982 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM PG. IT WAS REPORTED THAT THE FIBER WAS "FAULTY" AND "BROKEN." WHEN REMOVING FROM THE PACKAGING, IT WAS NOTED THE TIP WAS PARTIALLY BROKEN BUT NOT FULLY DETACHED. 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. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299940 ↗
• MalfunctionJun 9, 2021Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EVLT FIBER. DURING PREPARATION, THE FIBER FRACTURED WHEN THE PACKAGE WAS OPENED. ANOTHER SAME DEVICE WAS OPENED FOR THE FOLLOWING PROCEDURE AND 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 11967907 ↗
• MalfunctionMar 7, 2021Fracture; Fracture

  A VASCULAR SURGEON REPORTED AN ISSUE WITH A EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM. DURING PROCEDURE CLOSURE, WHEN WITHDRAWING THE FIBER FROM THE PATIENT, AFTER TREATING A 30CM GSV, IT WAS NOTED THAT THE FIBER WAS BROKEN AT THE 2CM DISTAL MARK. THE FIBER WAS FULLY FRACTURED, BUT STILL ATTACHED TO THE REST OF THE FIBER. IT IS FRACTURED AROUND THE PART THAT IS OUTSIDE THE SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 11429674 ↗
• MalfunctionMar 9, 2020Fracture; Fracture

  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 Patient Involvement

  MAUDE report 9805824 ↗
• InjuryJan 21, 2020Melted; Melted

  AS REPORTED: A PATIENT OF UNKNOWN GENDER AND AGE PRESENTED FOR AN EVLT PROCEDURE. DURING THE PROCEDURE, THE LAST 4CM OF THE SHEATH MELTED INSIDE OF THE PATIENT. THE PATIENT WAS SENT TO THE HOSPITAL, WHERE IT WHERE IT WAS DETERMINED BY THE TREATING PHYSICIAN TO NOT REMOVE THE SHEATH FRAGMENT. IT WAS DETERMINED THE VEIN WAS CLOSED, AND DUE TO THE LOCATION OF THE FRAGMENT, IT WOULD NOT MIGRATE. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9611621 ↗
• MalfunctionJan 13, 2020Fracture; Fracture

  AS REPORTED : DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS 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 9582290 ↗
• MalfunctionNov 5, 2019Fracture; Fracture

  DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS CRACKED/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 NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278162 ↗
• MalfunctionOct 11, 2019Fracture; Fracture

  AS REPORTED : DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS TESTED, THE FIBER APPEARED TO BE BENT AND ENERGY WAS COMING OUT OF THE SIDE OF THE LASER FIBER SHAFT. 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. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179470 ↗
• MalfunctionOct 10, 2019Fracture; Fracture

  AS REPORTED: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS TESTED, THE FIBER APPEARED TO BE BENT AND ENERGY WAS COMING OUT OF THE SIDE OF THE LASER FIBER SHAFT. 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. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9174540 ↗
• MalfunctionAug 6, 2019Fracture; Fracture

  A MALE PATIENT OF UNKNOWN AGE PRESENTED FOR AN EVLT PROCEDURE USING A 55OPS FIBER KIT. THE TREATING PHYSICIAN REPORTED THE WIRE (CHEATER?) BROKE OFF INTO THE SHEATH DURING USE. THE DEVICE WAS REMOVED AS A UNIT, SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THIS EVENT AS THE FRAGMENT WAS RETAINED INSIDE OF THE SHEATH. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866384 ↗
• MalfunctionApr 25, 2019Fracture; Fracture

  DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS 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. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8548915 ↗
• MalfunctionApr 2, 2019Fracture; Fracture

  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. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474752 ↗
• InjuryJan 29, 2019Crack; Crack

  IT WAS REPORTED THAT DURING AN EVLT PROCEDURE, THE LASER FIBER FRACTURED INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8286805 ↗
• MalfunctionDec 5, 2018Thermal Decomposition of Device; Fracture; Thermal Decomposition of Device; Fracture

  POST PROCEDURE, END OF EVLT OPS FIBER APPEARED TO BE BURNT. WHEN VIEWED UNDER MICROSCOPE THAT THE SURFACE OF THE OPS HAS TOTALLY BEEN BURNED, INDICATING THE FIBER HAD FRACTURED. THERE WAS NO REPORTED PATIENT HARM OR INJURY DUE TO THE EVENT. 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 8134935 ↗
• MalfunctionNov 2, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS CRACKED/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 NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033237 ↗
• MalfunctionSep 25, 2018Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING AN EVLT PROCEDURE, IT WAS NOTED THE FIBER APPEARED TO BE CHARRED. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7907017 ↗
• MalfunctionJul 31, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018, THE COMPLAINT WAS ORIGINALLY REPORTED AS A DEFECTIVE FIBER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. AS THERE WAS NO INDICATION OF AN ADVERSE EVENT, THE COMPLAINT WAS ASSESSED AS NOT REPORTABLE. HOWEVER, BASED ON THE EXAMINATION OF THE RETURNED LASER FIBER SAMPLE PERFORMED ON (B)(6) 2018, IT WAS NOTED THE FIBER WAS FRACTURED. BASED ON THE DEVICE EVALUATION, THE COMPLAINT WAS REASSESSED AS A REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7734946 ↗
• MalfunctionMay 11, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE TIP OF THE FIBER WAS 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 Patient Involvement

  MAUDE report 7506227 ↗
• MalfunctionMay 11, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE TIP OF THE FIBER WAS 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 Patient Involvement

  MAUDE report 7506213 ↗
• InjuryNov 7, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: PHYSICIAN MELTED PORTION OF THE SHEATH INSIDE PATIENT'S RIGHT GSV DURING PULLBACK. PATIENT HAD TO BE SENT TO SURGERY FOR REMOVAL OF THE SHEATH FROM VEIN. RVT IN THE ROOM STATES THAT FIBER AND SHEATH NOT LOCKED TOGETHER AT HUB WHEN PHYSICIAN PULLED BACK, AND THE PHYSICIAN STATED THAT IT WOULD HELP IF SHE HAD LOCKED IT AFTER REALIZING THAT THE FIBER HAD MOVED BACK INTO THE SHEATH. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE SHEATH FRAGMENT FROM THE VEN. IT WAS REPORTED THE PATIENT IS DOING WELL. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7007190 ↗

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.