VenaCure EVLT 11403012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787114030120), received between Apr 26, 2016 and Jan 28, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT 1 OF 2: A NURSE REPORTED A PATIENT ISSUE THAT OCCURRED DURING TWO SEPARATE EVLT PROCEDURES. THE PATIENT EXPERIENCED WHAT IS BELIEVED TO BE AN ALLERGIC REACTION DURING THE LAST 2 SESSIONS, RESULTING IN SWOLLEN LIPS AND TIGHTENING OF THE THROAT. TREATMENT WAS PAUSED UNTIL THE PATIENT IMPROVED AND THEN RESUMED ONCE THE PATIENT'S REACTION SUBSIDED. IT WAS REPORTED IT TOOK APPROXIMATELY 15 TO 20 MINUTES FOR THE REACTIONS TO SUBSIDE. THE TREATMENTS WERE THEN COMPLETED SUCCESSFULLY WITH NO FURTHER ALLERGIC REACTIONS. IN BOTH EVENTS, THE PATIENT WAS NOT TREATED WITH ANY MEDICATION OR INTERVENTION FOR THE ALLERGIC REACTION. THE PATIENT WILL BE SEEING AN ALLERGIST. IT WAS REPORTED THE PATIENT DOES HAVE AN ALLERGY TO AN UNDISCLOSED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13385462 ↗
• MalfunctionNov 21, 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 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 9355750 ↗
• MalfunctionOct 10, 2017Bent; Bent

  AS REPORTED TO ANGIODYNAMICS ON (B)(4) 2017: WHEN PREPPING FOR AN ENDOVENOUS LASER PROCEDURE, WHEN OPENING THE STERILE PACKAGING, IT WAS NOTED THE LASER FIBER WAS BENT IN HALF AND NOT USABLE. THE DEVICE WAS SET ASIDE AND ANEW OF THE SAME 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 Patient Involvement

  MAUDE report 6935054 ↗
• InjuryApr 26, 2016Thermal Decomposition of Device; Insufficient Device Problem Information; Thermal Decomposition of Device; Insufficient Device Problem Information

  AS REPORTED (B)(6) 2016, A FEMALE PATIENT OF UNKNOWN AGE PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF COMPLICATIONS OR DEVICE MALFUNCTION. WHEN FINISHING THE PROCEDURE, THE TREATING PHYSICIAN WITHDREW THE FIBER, AT WHICH POINT, THE FIBER FRACTURED. A PIECE OF THE FIBER REMAINED INSIDE OF THE PATIENT. THE PHYSICIAN SUCCESSFULLY REMOVED THE FRACTURED PIECE FROM THE PATIENT. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. 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 5609253 ↗

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