VenaCure EVLT 51403002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787514030020), received between Aug 17, 2017 and Jun 18, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

16 other recalls cover devices cleared under the same FDA submission (K102796, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2019Fracture; Fracture

  DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS FRACTURED. THE TIP REMAINED INSIDE OF THE SHEATH. 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 Consequences Or Impact To Patient

  MAUDE report 8708338 ↗
• MalfunctionJun 18, 2019Fracture; Fracture

  DURING PREPARATION FOR THE 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 Consequences Or Impact To Patient

  MAUDE report 8708328 ↗
• InjuryMay 29, 2019Fracture; Fracture

  A LEFT LEG GREAT SAPHENOUS EVLT WAS BEING PERFORMED ACCORDING TO NORMAL PROTOCOL. UPON COMPLETION OF THE PROCEDURE, THE TREATING PHYSICIAN REALIZED THE FIBER TIP WAS NOT ATTACHED TO THE FIBER. THE TIP REMAINED INSIDE THE INSERTION SITE. A HEMOSTAT WAS NEEDED TO REMOVE THE TIP FROM THE PATIENTS LEG. 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: Device Embedded In Tissue or Plaque

  MAUDE report 8649216 ↗
• MalfunctionOct 2, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON SEPTEMBER 06, 2017: DURING AN ENDOVENOUS LASER PROCEDURE, THE LASER FIBER FRACTURED WHEN ATTEMPTING TO INSERT INTO THE PATIENT. THE FIBER HAD NOT PENETRATED THE PATIENT AT THE TIME OF THE FRACTURE. 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 AS THE FIBER HAD NOT BEEN INSERTED AT THE TIME OF THE FRACTURE. 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 6908372 ↗
• MalfunctionSep 21, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON AUGUST 30, 2017: AT THE CLOSE OF AN EVLT PROCEDURE, IT WAS NOTED THE FIBER STOP ON THE FIBER SHAFT HAD DETACHED, CAUSING THE FIBER TO SHIFT. IT WAS REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED PRIOR TO THE FIBER STOP DETACHING. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882514 ↗
• MalfunctionAug 17, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON JULY 31, 2017: AT THE CLOSE OF AN EVLT PROCEDURE, IT WAS NOTED THE FIBER STOP ON THE FIBER SHAFT HAD DETACHED, CAUSING THE FIBER TO SHIFT. IT WAS REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED PRIOR TO THE FIBER STOP DETACHING. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6801046 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102796, K162914, K171921, K231945. One submission often covers many models, so check the product and lot details in each record.

• Z-1406-2013 · Apr 30, 2013 · Terminated
  AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Ca
• Z-0413-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE -- AngioDynamics, Inc.
• Z-0407-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit w/19Ga Needle, Catalog No./REF 11403006, STERILE -- AngioDynamics, I
• Z-0403-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE -- AngioDynamics, Inc.
• Z-0408-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403012, STERILE -- AngioDyn
• Z-0405-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE -- AngioDynamics, Inc. 603 Queen
• Z-0402-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, STERILE -- AngioDynamics, Inc.
• Z-0410-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog No./REF 51402007, STERILE -- AngioDynamics, Inc. 603 Queensbury, N
• Z-0406-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NT FRS 45cm Kit w/19Ga Needle, Catalog No./REF 11403005, STERILE -- AngioDynamics, I
• Z-0414-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 65cm Clear Non-Echo Needle, Catalog No./REF 51403005, STERILE -- AngioDynamics, Inc. 603 Qu
• Z-0409-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE -- AngioDyn
• Z-0412-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm Clear Needle, Catalog No./REF 51403001, STERILE -- AngioDynamics, Inc. 6
• Z-0411-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog No./REF 51402008, STERILE -- AngioDynamics, Inc. 603 Queensbury, N
• Z-0400-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE -- AngioDynamics, Inc. 603 Queensb
• Z-0401-2012 · Nov 10, 2011 · Terminated
  VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE -- AngioDynamics, Inc. 603 Queensb

…and 1 more.