VenaCure EVLT EVLT/25-OPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI H787EVLT25OPS0), received between Apr 13, 2016 and Apr 3, 2024 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Fracture; Fracture

  AN ULTRASOUND TECHNOLOGIST REPORTED THE FOLLOWING ISSUE WITH AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 25CM: "WHILE DR. (B)(6) WAS PERFORMING AN SSV EVLT, THE 25 CM EVLT LASER KIT THAT WAS OPENED FOR THE PROCEDURE COULD NOT BE USED DUE TO A LASER FIBER THAT FRACTURED COMPLETELY IN HALF RIGHT AFTER DR. (B)(6) GOT IT CORRECTLY POSITIONED IN THE SSV. THE LASER FIBER WAS INITIALLY LOCKED INTO PLACE WITHIN THE CATHETER, BUT BEFORE WE STARTED TO INJECT THE TUMESCENCE, THE LASER FIBER APPEARED TO POP OUT OF THE CATHETER. DR. (B)(6) COMMENTED THAT THIS WAS WEIRD AS HE THOUGHT THAT IT WAS LOCKED INTO PLACE. WHEN HE WENT TO RE-INSERT THE LASER FIBER, HE NOTICED THAT HE COULDN'T PASS THE LASER FIBER THROUGH THE CATHETER ANYMORE. AFTER TRYING FOR A FEW MINUTES, HE USED A SCALPEL TO CUT THE LOCK END OF THE CATHETER OFF TO SEE IF HE COULD FIGURE OUT WHAT WAS HAPPENING. IT WAS AFTER HE CUT THE CATHETER THAT DR. (B)(6) REALIZED THAT THE LASER FIBER HAD CRACKED COMPLETELY OFF INSIDE THE CATHETER. WE REMOVED THE BROKEN PIECE AND PUT THE BROKEN FIBER BACK INTO THE ORIGINAL PACKAGING BEFORE OPENING A NEW EVLT KIT TO FINISH THE LASER ABLATION PROCEDURE." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038796 ↗
• MalfunctionNov 4, 2022Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EVLT KIT, WITH SPOTLIGHT OPS SHEATH 25CM. DURING PREPARATION, THE FIBER WAS REMOVED FROM THE PACKAGING AND THE TIP WAS DISCOVERED TO BE BENT/CRACKED. THERE WAS NO VISIBLE DAMAGE TO THE INTERNAL OR EXTERNAL 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 15735774 ↗
• InjuryDec 27, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 25CM. DURING A GSV PROCEDURE, THE FIBER BROKE WHILE INSIDE OF THE PATIENT. THE PATIENT REQUIRED SURGERY TO REMOVE THE FRAGMENT. APART FROM SURGERY, IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13087342 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 25CM. WHILE UNPACKING THE DEVICE FOR A PROCEDURE, IT WAS NOTED THAT THE TIP APPEARED TO BE DAMAGED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE EVENT 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 12299936 ↗
• MalfunctionDec 10, 2020Fracture; Fracture

  AN END USER REPORTED AN ISSUE WHEN OPENING AN EVLT 25OPS FIBER FOR AN EVLT PROCEDURE. WHEN THE STERILE PACKAGE WAS OPENED, IT WAS NOTED BY THE PHYSICIAN THAT THE 25 CM OPS FIBER WAS KINKED AND BROKEN. THE FIBER WAS SET ASIDE AND A NEW FIBER PACK WAS OPENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW FIBER WITH NO HARM OR INJURY TO THE PATIENT. 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 10984139 ↗
• MalfunctionNov 12, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EVLT FIBER. PRIOR TO PLACING THE FIBER, THE TREATING PHYSICIAN NOTED THE FIBER WAS FRACTURED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THIS EVENT. 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 10828814 ↗
• 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 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 9805804 ↗
• MalfunctionFeb 20, 2019Crack; Crack

  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 8355260 ↗
• MalfunctionApr 10, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON MARCH 28, 2018: AT THE START OF AN ENDOVENOUS LASER TREATMENT PROCEDURE, IT WAS NOTED THE LASER FIBER WAS BENT/FRACTURED NEAR THE TIP. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY AS THE DEVICE HAD NOT COME INTO CONTACT WITH 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 7411773 ↗
• MalfunctionJan 11, 2017Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  AS REPORTED (B)(6) 2017, A (B)(6) YEAR OLD, FEMALE PATIENT PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. 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 Known Impact Or Consequence To Patient

  MAUDE report 6242024 ↗
• MalfunctionJan 11, 2017Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  AS REPORTED JANUARY 04, 2017, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING THE PROCEDURE, THE FIBER WAS FRACTURED INSIDE OF THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS 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: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6241958 ↗
• MalfunctionNov 18, 2016Crack; Fracture; Crack; Fracture

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. 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 EVALUATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6112095 ↗
• MalfunctionAug 23, 2016Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. 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 REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 5897107 ↗
• MalfunctionAug 23, 2016Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. 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 REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 5897105 ↗
• MalfunctionApr 13, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. 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 Information

  MAUDE report 5573779 ↗
• MalfunctionApr 13, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. 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 NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Information

  MAUDE report 5573439 ↗

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.