VenaCure EVLT 11403004Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H787114030040), received between Dec 19, 2018 and Apr 12, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  FIBER 2 OF 4. AN END USER REPORTED AN ISSUE WITH FOUR VC EVLT NEVERTOUCH-FRS 90CM KITS (ALL THE SAME LOT NUMBER). DURING A PROCEDURE, IT WAS NOTED THAT THE LASER EXTENDED 10-15CM PAST THE END OF THE CATHETER, WHEN HUBBED. THE FIBERLOK HAD DETACHED FROM THE FIBER SHAFT AND ALLOWED IT TO SLIDE FREELY ALONG THE FIBER SHAFT. THIS WAS NOTED WHEN USING ULTRASOUND TO DOUBLE CHECK THE SPOT OF THE FIBER TIP BEFORE ACTIVATING THE FIBER. THE FIBER HAD ALREADY BEEN PLACED INSIDE THE PATIENT. THE TREATING PHYSICIAN DETERMINED TO COMPLETE THE PROCEDURE WITH THE DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 11648312 ↗
• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  FIBER 4 OF 4. AN END USER REPORTED AN ISSUE WITH FOUR VC EVLT NEVERTOUCH-FRS 90CM KITS (ALL THE SAME LOT NUMBER). DURING A PROCEDURE, IT WAS NOTED THAT THE LASER EXTENDED 10-15CM PAST THE END OF THE CATHETER, WHEN HUBBED. THE FIBERLOK HAD DETACHED FROM THE FIBER SHAFT AND ALLOWED IT TO SLIDE FREELY ALONG THE FIBER SHAFT. THIS WAS NOTED WHEN USING ULTRASOUND TO DOUBLE CHECK THE SPOT OF THE FIBER TIP BEFORE ACTIVATING THE FIBER. THE FIBER HAD ALREADY BEEN PLACED INSIDE THE PATIENT. THE TREATING PHYSICIAN DETERMINED TO COMPLETE THE PROCEDURE WITH THE DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 11648309 ↗
• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  FIBER 3 OF 4. AN END USER REPORTED AN ISSUE WITH FOUR VC EVLT NEVERTOUCH-FRS 90CM KITS (ALL THE SAME LOT NUMBER). DURING A PROCEDURE, IT WAS NOTED THAT THE LASER EXTENDED 10-15CM PAST THE END OF THE CATHETER, WHEN HUBBED. THE FIBERLOK HAD DETACHED FROM THE FIBER SHAFT AND ALLOWED IT TO SLIDE FREELY ALONG THE FIBER SHAFT. THIS WAS NOTED WHEN USING ULTRASOUND TO DOUBLE CHECK THE SPOT OF THE FIBER TIP BEFORE ACTIVATING THE FIBER. THE FIBER HAD ALREADY BEEN PLACED INSIDE THE PATIENT. THE TREATING PHYSICIAN DETERMINED TO COMPLETE THE PROCEDURE WITH THE DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 11648308 ↗
• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  FIBER 1 OF 4. AN END USER REPORTED AN ISSUE WITH FOUR VC EVLT NEVERTOUCH-FRS 90CM KITS (ALL THE SAME LOT NUMBER). DURING A PROCEDURE, IT WAS NOTED THAT THE LASER EXTENDED 10-15CM PAST THE END OF THE CATHETER, WHEN HUBBED. THE FIBERLOK HAD DETACHED FROM THE FIBER SHAFT AND ALLOWED IT TO SLIDE FREELY ALONG THE FIBER SHAFT. THIS WAS NOTED WHEN USING ULTRASOUND TO DOUBLE CHECK THE SPOT OF THE FIBER TIP BEFORE ACTIVATING THE FIBER. THE FIBER HAD ALREADY BEEN PLACED INSIDE THE PATIENT. THE TREATING PHYSICIAN DETERMINED TO COMPLETE THE PROCEDURE WITH THE DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 11648306 ↗
• MalfunctionJan 22, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  AS REPORTED: A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN EVLT PROCEDURE USING THE NEVER TOUCH SYSTEM. DURING THE PROCEDURE, THE FIBER STOP DETACHED, ALLOWING THE LASER FIBER TO ADVANCE FURTHER INTO THE PATIENT THAN ANTICIPATED. IT WAS REPORTED THE FIBER HAD BEEN FIRED PRIOR TO NOTICING THE LOOSE FIBER STOP, BUT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE LOOSE FIBER STOP. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 9617319 ↗
• MalfunctionApr 5, 2019Fracture; Fracture

  DURING AN EVLT PROCEDURE, THE PATIENT'S FIRST VEIN WAS SUCCESSFULLY TREATED. WHILE THE PHYSICIAN WAS CLEANING THE FIBER IN ORDER TO TREAT THE PATIENT'S SECOND VEIN, THE TIP OF THE LASER FIBER FRACTURED OFF. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. THE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486458 ↗
• MalfunctionDec 19, 2018Fracture; Fracture

  DURING AN EVLT PROCEDURE, WHEN THE LASER FIBER WAS FIRED, IT DID NOT APPEAR TO BE ANY STEAM BUBBLES. THE DEVICE WAS WITHDRAWN AND IT WAS NOTED THE FIBER APPEARED TO BE CRACKED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO 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

  MAUDE report 8181219 ↗

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