VenaCure EVLT 11403006Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H787114030060), received between Jun 8, 2016 and Oct 25, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2021Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  DEVICE 2 OF 2: A PHYSICIAN REPORTED THAT 2 OF THE 9 NEVERTOUCH FRS 65CM KITS RECEIVED AT THE ACCOUNT, CONTAINED BENT FIBERS. THIS WAS DISCOVERED, DURING PROCEDURE PREPARATION, WHEN THE FIBERS WERE TAKEN OUT OF THE BOX AND WERE INSPECTED. THE CUSTOMER HAD TO OPEN AN ADDITIONAL KIT TO COMPLETE THE FOLLOWING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS THE DEVICE WAS NOT USED FOR PATIENT TREATMENT. IT WAS REPORTED THERE WAS NO SHIPPING DAMAGE TO THE OUTER SHIPPER BOX OR KIT PACKAGING. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688062 ↗
• MalfunctionOct 25, 2021Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  DEVICE 1 OF 2: A PHYSICIAN REPORTED THAT 2 OF THE 9 NEVERTOUCH FRS 65CM KITS RECEIVED AT THE ACCOUNT, CONTAINED BENT FIBERS. THIS WAS DISCOVERED, DURING PROCEDURE PREPARATION, WHEN THE FIBERS WERE TAKEN OUT OF THE BOX AND WERE INSPECTED. THE CUSTOMER HAD TO OPEN AN ADDITIONAL KIT TO COMPLETE THE FOLLOWING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS THE DEVICE WAS NOT USED FOR PATIENT TREATMENT. IT WAS REPORTED THERE WAS NO SHIPPING DAMAGE TO THE OUTER SHIPPER BOX OR KIT PACKAGING. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688061 ↗
• MalfunctionAug 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NEVERTOUCH FIBER, EVENT #3. AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EVLT FIBER 65CM KIT. THE GOLD JACKET WAS CAUGHT IN THE END OF THE TRE-SHEATH AND CAME OFF WHEN THE FIBRE WAS PULLED OUT OF THE PATIENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. IT WAS REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF PATIENT COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10388108 ↗
• MalfunctionAug 10, 2020Loss of or Failure to Bond; Continuous Firing; Crack; Material Discolored; Failure to Deliver Energy; Fracture; Material Frayed; Melted; Migration or Expulsion of Device; Material Opacification; Unsealed Device Packaging; Device Remains Activated; Difficult to Remove; Stretched; Material Perforation; Device Damaged Prior to Use; Failure to Deliver; Tear, Rip or Hole in Device Packaging; Dull, Blunt; Failure to Advance; Failure to Fire; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping; Difficult to Open or Remove Packaging Material; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Migration; Loss of or Failure to Bond; Continuous Firing; Crack; Material Discolored; Failure to Deliver Energy; Fracture; Material Frayed; Melted; Migration or Expulsion of Device; Material Opacification; Unsealed Device Packaging; Device Remains Activated; Difficult to Remove; Stretched; Material Perforation; Device Damaged Prior to Use; Failure to Deliver; Tear, Rip or Hole in Device Packaging; Dull, Blunt; Failure to Advance; Failure to Fire; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Markings/Labelling Problem; Device Misassembled During Manufacturing /Shipping; Difficult to Open or Remove Packaging Material; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Migration

  NEVERTOUCH FIBER, EVENT #1. AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EVLT FIBER 65CM KIT. THE GOLD JACKET WAS CAUGHT IN THE END OF THE TRE-SHEATH AND CAME OFF WHEN THE FIBRE WAS PULLED OUT OF THE PATIENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. IT WAS REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF PATIENT COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10388045 ↗
• MalfunctionAug 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NEVERTOUCH FIBER, EVENT #2. AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EVLT FIBER 65CM KIT. THE GOLD JACKET WAS CAUGHT IN THE END OF THE TRE-SHEATH AND CAME OFF WHEN THE FIBRE WAS PULLED OUT OF THE PATIENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. IT WAS REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF PATIENT COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387991 ↗
• InjuryMay 11, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: AFTER DOING A SUCCESSFUL EVLT PROCEDURE,WHEN THE PA TRIED TO REMOVE THE LASER OUT OF THE SHEATH, THE TIP OF THE FIBER DETACHED AND REMAINED INSIDE OF THE SHEATH. THERE WAS NO PATIENT IMPACT 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 7506215 ↗
• MalfunctionAug 3, 2016Fracture; Fracture

  RECEIVED NOTIFICATION FROM (B)(6) ON JULY 05, 2016 VIA USPS, (B)(4). AS REPORTED ,A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE OF THE LEFT LEG. DURING THE PROCEDURE, THE TREATING PHYSICIAN USED ULTRASOUND TO GUIDE THE TIP OF THE LASER FIBER. WHILE DOING SO, IT WAS NOTED THE LASER FIBER WAS NOT EMITTING STEAM BUBBLES. THE PHYSICIAN WITHDREW THE LASER FIBER WHICH APPEARED TO BE BLACKENED AND FRACTURED. A PIECE OF THE LASER FIBER REMAINED INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED VIA CUTDOWN. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE 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 5842831 ↗
• MalfunctionJun 8, 2016Uncoiled; Insufficient Device Problem Information; Uncoiled; Insufficient Device Problem Information

  AS REPORTED (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING THE PROCEDURE, WHILE PULLING THE GUIDEWIRE BACK THROUGH THE NEEDLE, THE GUIDEWIRE WAS DAMAGED. NO PIECE OF THE GUIDEWIRE REMAINED INSIDE OF THE PATIENT. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OF THE SAME DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 5706140 ↗

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