VenaCure EVLT 11403003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787114030030), received between Feb 13, 2017 and Oct 14, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED THE FOLLOWING ISSUE WITH A NEVER TOUCH 45CM KIT W/GRIPPER AND RFID T: "AFTER PROCEDURE DONE ON PATIENT, DR. (B)(6) LOOKED AT THE BLUE DILATOR AS HE ALWAYS DOES AS HE PUTS IT DOWN AND NOTICED THAT THE END PIECE WAS MISSING. HE TOLD RUSSELL OUR ULTRA SOUND TECH TO LOOK AND SEE IF HE COULD SEE ANYTHING, THERE WAS A PIECE OF THE BLUE DILATOR IN PATIENTS RIGHT UPPER LEG. DR. (B)(6) INSTRUCTED PATIENT WHAT WAS HAPPENING. DR. (B)(6) USED 3CC OF 2% LIDOCAINE, 11 BLADE SCALPEL AND MADE AN INCISION INTO PATIENTS RIGHT UPPER LEG. DR. (B)(6) HAD TO USE HEMOSTATS TO GRAB THE VEIN AND THE BLUE DILATOR WAS LOCATED. DR. (B)(6) PULLED FRAGMENT OUT OF THE VEIN AND HE PUT IN TWO STITCHES, THE LEG WAS CLEANED AND ANTIBIOTIC CREAM APPLIED WITH STERI STRIPS AND 4 X 4 DRESSING. ANTIBIOTIC CALLED IN FOR PATIENT." AN ANGIODYNAMICS CLINICAL SUPPORT MANAGER CONTACTED THE END USER FOR ADDITIONAL INFORMATION. THE FOLLOWING STEP-BY-STEP PROCEDURE DETAILS WERE OBTAINED: 1. VEIN WAS ACCESSED AND VENOTOMY PERFORMED BEFORE THE 21GA NEEDLE WAS REMOVED. 2. SHEATH/DILATOR INSERTED OVER THE WIRE AND INTO THE TARGET VEIN (US TECH DID NOT BELIEVE A SECOND VENOTOMY WAS DONE) 3. PHYSICIAN HAD DIFFICULT

  Patient problems: Foreign Body In Patient

  MAUDE report 20439589 ↗
• MalfunctionMar 7, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: WHEN OPENING THE STERILE PACKAGING DURING PREP FOR AN EVLT PROCEDURE, IT WAS NOTED THE LASER FIBER WAS BENT INSIDE OF THE PACKAGE. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6384311 ↗
• MalfunctionFeb 13, 2017Crack; Fracture; Device Damaged Prior to Use; Crack; Fracture; Device Damaged Prior to Use

  AS REPORTED (B)(6) 2017:WHEN PREPPING FOR AN EVLT PROCEDURE, WHEN OPENING THE STERILE PACKAGING, IT WAS NOTED THE LASER FIBER WAS BENT. 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. 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; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6325247 ↗

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