VenaCure EVLT EVLT/80-OPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI H787EVLT80OPS0), received between May 18, 2016 and Aug 23, 2022 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Crack” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Fracture; Fracture

  A PHYSICIAN REPORTED AN ISSUE WITH AN EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM. IT WAS REPORTED THAT WHEN OPENING THE EVLT KIT FOR A PROCEDURE, THE FIBER WAS PARTIALLY FRACTURED IN THE PACKAGE. 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 15278759 ↗
• MalfunctionDec 1, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EVLT KIT. DURING PREPARATION, IT WAS NOTED THAT THE FIBER WAS BROKEN, UPON OPENING. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT, BY THE END USER. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 10927134 ↗
• InjuryNov 3, 2020Fracture; Melted; Fracture; Melted

  A VEIN CLINIC COORDINATOR REPORTED AN ISSUE WITH AN EVLT KIT, WITH SPOTLIGHT OPS SHEATH 80CM PG. DURING A PROCEDURE, THE END USER WAS CONCERNED THAT THE SHEATH WAS NOT COMPLETELY TWIST-LOCKING ONTO THE FIBER. THE FIBER ENDING UP BURNING THROUGH THE SHEATH. PHOTOS PROVIDED OF THE SHEATH SHOW THAT A PIECE OF THE COMPONENT IS NO LONGER INTACT. THE DOCTOR IS UNSURE IF ANY PIECE OF THE DEVICE WAS LEFT IN THE PATIENT. THE PATIENT WAS SENT HOME AND A FOLLOW UP WILL BE CONDUCTED IN THE NEAR FUTURE. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10777215 ↗
• InjuryNov 26, 2019Fracture; Fracture

  TIP OF SHEATH AND FIBER WERE BURNED APPROXIMATELY 2 CM FROM THE TIP AND ARE INSIDE THE SSV OF THE LEFT LEG 2 CM FROM THE DEEP SYSTEM. THEY NOTICED AFTER TREATING THE SSV, 17 CM, AND INSPECTED THE TIP. THE BLACK MARKERS TILL 2 CM WERE MISSING, AND THE FIBER DIDN'T COME OUT OF THE SHEATH. ULTRASOUND CONFIRMED THE MISSING PART INSIDE THE PATIENT. 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 9377382 ↗
• MalfunctionJun 26, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING PREPARATION FOR THE EVLT 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 Patient Involvement

  MAUDE report 7638946 ↗
• MalfunctionJun 5, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON MAY 16, 2018: 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 7569825 ↗
• MalfunctionJun 5, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON MAY 16, 2018: 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 7569820 ↗
• InjuryNov 7, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING THE EVLT PROCEDURE, IT WAS NOTED THE FIBER HAD FRACTURED INSIDE OF THE PATIENT. THE FRACTURED FIBER WAS REMOVED AND THE DEVICE WAS SET ASIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OF THE SAME DEVICE. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY TO 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: Device Embedded In Tissue or Plaque

  MAUDE report 7007199 ↗
• MalfunctionNov 7, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON OCTOBER 31, 2017: DURING AN EVLT PROCEDURE, AS THE TREATING PHYSICIAN WAS FIRING THE LASER FIBER, HE FELT HEAT ON THE PATIENT'S LEG. HE IMMEDIATELY STOPPED FIRING AND WITHDREW THE FIBER. NO PIECE OF THE FIBER FRAGMENTED OFF INSIDE OF THE PATIENT. IT WAS NOTED THE FIBER HAD A CRACK IN THE SHAFT. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Burn(s)

  MAUDE report 7007193 ↗
• InjuryFeb 15, 2017Crack; Crack

  AS REPORTED (B)(6) 2016 A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED UNDER ULTRASOUND, THE FIBER HAD FRACTURED INSIDE OF THE SHEATH, CAUSING THE SHEATH TO FRACTURE OFF INSIDE OF THE PATIENT WITH THE FRAGMENT OF LASER FIBER INSIDE OF IT. VIA A CUT DOWN, THE FRAGMENTS WERE SUCCESSFULLY REMOVED. THE DEFECTIVE DEVICE WAS SET ASIDE AND A NEW OF TE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT 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: Device Embedded In Tissue or Plaque

  MAUDE report 6332310 ↗
• MalfunctionSep 21, 2016Crack; Fracture; Device Damaged Prior to Use; Crack; Fracture; Device Damaged Prior to Use

  AS REPORTED (B)(6) 2016, A (B)(6), MALE 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. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5966063 ↗
• MalfunctionMay 18, 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. 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 5664411 ↗

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.