VenaCure EVLT 11403005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787114030050), received between Feb 3, 2017 and Mar 9, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionMar 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN EVLT PROCEDURE USING A NEVERTOUCH FIBER. THE TREATING PHYSICIAN SUCCESSFULLY TREATED THE PATIENT'S FIRST LEG, AND WITHDREW THE FIBER IN ORDER TO TREAT THE SECOND LEG. WHILE CLEANING THE LASER FIBER PRIOR TO INSERTION INTO THE SECOND LEG, THE GOLD TIP OF THE FIBER DETACHED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805818 ↗
• MalfunctionOct 30, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON OCTOBER 05, 2017: DURING AN EVLT PROCEDURE, THE TREATING PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE ON THE PATIENT'S FIRST LEG. THE FIBER WAS PLACED IN THE PATIENT'S SECOND LEG WITH NO REPORT OF COMPLICATIONS. WHEN WITHDRAWING THE LASER FIBER FROM THE SECOND LEG, IT WAS NOTED THE FIBER STOP HAD DETACHED FROM THE FIBER SHAFT. IT WAS REPORTED THE FIBER EXTENDED FROM THE SHEATH APPROXIMATELY 9 CM WHEN WITHDRAWN. DUE TO THIS, THE DOCTOR IS UNSURE AS TO WHETHER OR NOT THE PATIENT'S VEIN HAD BEEN ABLATED FOR THE FINAL 6- 9 CENTIMETERS. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS INDICATED 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 6986732 ↗
• InjuryOct 2, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING THE PROCEDURE, WHEN THE TREATING PHYSICIAN ATTEMPTED TO FIRE THE LASER WITH THE FIBER INSERTED INTO THE PATIENT, THE FIBER FRACTURED DISTAL TO THE INSERTION SITE, THE PHYSICIAN WAS ABLE TO GRASP THE FIBER FRAGMENT AND PULL IT OUT OF THE PATIENT. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT SUFFER ANY SERIOUS HARM OR INJURY DUE TO THIS 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 6907238 ↗
• MalfunctionFeb 3, 2017Unsealed Device Packaging; Device Packaging Compromised; Unsealed Device Packaging; Device Packaging Compromised

  AS REPORTED (B)(6) 2017, WHEN THE REPORTING MEDICAL FACILITY RECEIVED THE PRODUCT, ONE OF THE PACKAGES WITHIN THE SHIPMENT HAD A TEAR IN THE PACKAGING, COMPROMISING THE STERILITY OF THE PRODUCT CONTAINED WITHIN. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6299636 ↗

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