VenaCure EVLT 11403002Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI H787114030020), received between Aug 3, 2016 and Jun 23, 2025 — classified as 12 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EVLT LASER FIBER. IT WAS REPORTED THE PROCEDURE WAS PERFORMED ON (B)(6). 1 WEEK POST PROCEDURE , IT WAS FOUND ON A FOLLOW UP ULTRASOUND THAT A PORTION OF THE FIBER HAD DETACHED AND WAS RETAINED INSIDE THE PATIENT. THE RETAINED FRAGMENT WAS RETRIEVED TWO DAYS LATER VIA A SMALL CUT DOWN ON THE GREAT SAPHENOUS VEIN AT THE KNEE AND THEN PULLED OUT THE FRAGMENT USING CLAMPS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22308174 ↗
• InjuryAug 22, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED A CUSTOMER COMPLAINT AGAINST A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID T. DURING A PROCEDURE, WHEN THE SURGEON REMOVED THE LASER FIBER FROM THE PATIENT'S VEIN, THE TIP WAS NO LONGER ATTACHED. THE SONOGRAPHER PERFORMED AN ULTRASOUND OF THE DISTAL THIGH GREAT SAPHENOUS VEIN AND IDENTIFIED THE LASER TIP STILL LOCATED WITHIN THE VESSEL. ULTIMATELY, THE VASCULAR SURGEON PERFORMED A SURGICAL INCISION TO REMOVE THE TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 20038188 ↗
• MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN DISTRIBUTOR REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID T. DURING A PROCEDURE, THE GOLD TIP DETACHED FROM THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT IS UNKNOWN WHEN THE TIP DETACHED. IT WAS REPORTED THAT THE "NURSE NOTICED THE METAL END OF THE FIBER WAS ON THE STERILE TROLLEY AND THE LASER FIBER HAD A BARE END."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047942 ↗
• MalfunctionMar 24, 2024Thermal Decomposition of Device; Detachment of Device or Device Component; Thermal Decomposition of Device; Detachment of Device or Device Component

  AN END USER REPORTED THE FOLLOWING ISSUE WITH A NEVER TOUCH 65CM KIT W/GRIPPER AND RFID T: CUSTOMER (B)(6) CONTACTED TM (B)(6) AROUND 10AM TO REPORT THAT DR (B)(6) WAS DOING AN EVLT CASE ON 3/8 AND EXPERIENCED A LOSS OF THE TRE SHEATH TIP (2-3CM'S) UPON COMPLETION OF THE PROCEDURE. I CONTACTED THE ACCOUNT AT 10:45AM AND SPOKE WITH (B)(6) (RN). (B)(6) REPORTED THE PATIENT WAS AN APPROXIMATELY 65 Y/O MALE UNDERGOING EVLT OF A SSV WITH THIGH EXTENSION. DOCTOR (B)(6) NOTED THE MISSING SHEATH TIP AT THE END OF THE PROCEDURE. (B)(6) REPORTS THAT THE LASER FIBER HUB MAY HAVE NOT BEEN SECURED TO THE TRE SHEATH HUB PRIOR TO INITIATING TREATMENT. PER (B)(6), PATIENT WAS NOT REPORTED TO HAVE SUFFERED INJURY. PATIENT WAS SEEN YESTERDAY FOR ULTRASOUND FOLLOW-UP. SHEATH FRAGMENT NOTED TO BE PRESENT IN THE VEIN. CUSTOMER HAS BEEN INFORMED THAT THE FRAGMENT SHOULD BE REMOVED; HOWEVER, THE PATIENT VOICED SOME RESISTANCE. AT THIS TIME, THE FRAGMENT REMAINS IN SITU BUT AN ULTRASOUND HAS BEEN SCHEDULED FOR A FUTURE DATE. DESPITE THE FRAGMENT, THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966553 ↗
• MalfunctionMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A FIBER FROM A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID TAG KIT. THE PHYSICIAN TREATED THE FIRST VEIN SUCCESSFULLY WITH THE LASER FIBER AND REMOVED THE FIBER FROM THE SHEATH, IN PREPARATION TO TREAT THE SECOND VEIN. WHILE REMOVING THE LASER FIBER FROM THE SHEATH, THE 'GOLD JACKET TIP' CAME OFF INSIDE THE SHEATH. THIS OCCURRED OUTSIDE OF THE PATIENT AND THE PATIENT WAS UNAFFECTED. THE PHYSICIAN USED A NEW LASER FIBER TO SUCCESSFULLY TREAT THE SECOND VEIN SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903600 ↗
• MalfunctionMar 11, 2024Fracture; Fracture

  AN END USER REPORTED THAT THE ACCOUNT HAS RECEIVED 3 BROKEN NEVERTOUCH FRS 65CM PROCEDURE KITS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, BY THE END USER, AS THE ISSUE WAS DISCOVERED WHILE UNPACKING THE DEVICES. NO FURTHER DETAILS WERE ABLE TO BE PROVIDED. DEVICE 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882773 ↗
• MalfunctionMar 11, 2024Fracture; Fracture

  AN END USER REPORTED THAT THE ACCOUNT HAS RECEIVED 3 BROKEN NEVERTOUCH FRS 65CM PROCEDURE KITS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, BY THE END USER, AS THE ISSUE WAS DISCOVERED WHILE UNPACKING THE DEVICES. NO FURTHER DETAILS WERE ABLE TO BE PROVIDED. DEVICE 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882739 ↗
• MalfunctionMar 11, 2024Fracture; Fracture

  AN END USER REPORTED THAT THE ACCOUNT HAS RECEIVED 3 BROKEN NEVERTOUCH FRS 65CM PROCEDURE KITS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, BY THE END USER, AS THE ISSUE WAS DISCOVERED WHILE UNPACKING THE DEVICES. NO FURTHER DETAILS WERE ABLE TO BE PROVIDED. DEVICE 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881701 ↗
• MalfunctionJan 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A FIBER FROM A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID TAG KIT. THE PHYSICIAN TREATED THE FIRST VEIN SUCCESSFULLY WITH THE LASER FIBER. ALL COMPONENTS WERE REMOVED AND SET BACK ON THE STERILE FIELD IN PREPARATION FOR TREATMENT OF A SECOND VEIN. WHILE REMOVING THE LASER FIBER FROM THE SHEATH, THE 'GOLD JACKET TIP' CAME OFF INSIDE THE SHEATH. THIS OCCURRED OUTSIDE OF THE PATIENT AND THE PATIENT WAS UNAFFECTED. THE PHYSICIAN USED A NEW LASER FIBER TO SUCCESSFULLY TREAT THE SECOND VEIN SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444411 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT W/ GRIPPER AND RFID T. DURING A PROCEDURE, THE FIBER WOULD WORK AND THEN SHUT OFF. THIS CYCLE WAS PERFORMED TWICE; HOWEVER, ANOTHER SAME DEVICE WAS ULTIMATELY USED TO COMPLETE THE PROCEDURE. FIVE DAYS FOLLOWING THE PROCEDURE, PATIENT REPORTED FEELING COLDNESS, NUMBNESS AND A "BUZZ" IN HER LEG. THE NURSE BELIEVES THIS MAY BE NERVE DAMAGE AND WILL TAKE SOME TIME TO RESOLVE; HOWEVER, THE PATIENT DOES NOT REQUIRE ANY TYPE OF MEDICAL INTERVENTION FOR THESE SYMPTOMS.

  Patient problems: Numbness; Undesired Nerve Stimulation

  MAUDE report 18290650 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

  A PHYSICIAN REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT. WHILE UNPACKING THE DEVICE, IT WAS NOTED THAT THE LASER FIBER LOOKED BENT/ KINKED. UPON FURTHER INSPECTION, THE FIBER SNAPPED INTO TWO PIECES. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THERE WAS NO DAMAGED NOTED TO THE INTERNAL OR EXTERNAL PACKAGING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994499 ↗
• MalfunctionOct 10, 2023Thermal Decomposition of Device; Melted; Smoking; Thermal Decomposition of Device; Melted; Smoking

  AN END USER REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT. APPROXIMATELY 8-10 SECONDS INTO THE LASING PROCEDURE, WITH THE GENERATOR SET AT 6 WATTS / 42J, THE SHEATH BEGAN MELTING AT THE POINT WHERE IT CONNECTS TO THE LASER FIBER. VISIBLE SMOKE AND A BURNING SMELL WERE NOTED: HOWEVER, THERE WERE NO ERROR MESSAGES DISPLAYED ON THE GENERATOR. THE PATIENT AND DEVICE OPERATOR DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905774 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT, WITH GRIPPER AND RFID. DURING A PROCEDURE, THE FIRST SEGMENT WAS SUCCESSFULLY COMPLETED AND THE FIBER WAS COMPLETELY REMOVED FROM THE PATIENT. WHEN THE PHYSICIAN WENT TO CLEAN THE TIP OF THE FIBER, IT BECAME DETACHED FROM THE SHAFT. THE SECOND SEGMENT WAS TREATED WITH A NEW FIBER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765985 ↗
• MalfunctionJul 20, 2023Fracture; Fracture

  A USER FACILITY'S PHYSICIAN REPORTED THAT DURING EVLT PROCEDURE PREPARATION USING A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID TAG, THE EVLT FIBER WAS CONNECTED TO THE VASCULAR SOLUTIONS VARILASE UNIT AND PLACED DOWN ON TOP OF A FOLDED GOWN ON THE PROCEDURE TABLE. IT WAS REPORTED THAT UPON CONNECTING THE FIBER TO THE POWER SOURCE, THE TIP FRACTURED OFF AND BURNED THE FOLDED GOWN. THE PHYSICIAN REPORTED THAT NO ENERGY HAD BEEN APPLIED THROUGH THE FIBER, NOR HAD A TEST FIRE BEEN PERFORMED PRIOR TO THIS OCCURRING. THE PHYSICIAN DECIDED TO CONTINUE USING THE SAME FIBER AND INSERTED IT INTO THE PATIENT WITHOUT THE TIP. THE PROCEDURE WAS COMPLETED WITH NO VEIN CLOSURE. THE PATIENT DID NOT EXPERIENCE ANY HARM, ADVERSE EVENTS, OR REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364252 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  END USER REPORTED THAT THE TIP OF 65CM NEVERTOUCH EVLT FIBER BROKE OFF IN THE CATHETER/SHEATH AFTER BEING USED FOR PATIENT TREATMENT. THIS OCCURRED OUTSIDE OF THE PATIENT AS THE PROCEDURE HAD BEEN COMPLETED. THERE WAS NO DAMAGE VISUALLY OBSERVED TO THE PACKAGING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071826 ↗
• InjuryApr 3, 2023Melted; Melted

  DURING AN EVLT PROCEDURE, USING A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID T PROCEDURE KIT, THE SHEATH BURNED OFF INSIDE THE PATIENT AND WAS RETAINED IN THE PATIENT'S VEIN. PHYSICIAN HAD TO PERFORM A MINOR VEIN CUT DOWN TO RETRIEVE THE RETAINED PORTION OF THE SHEATH AFTER LOCATING VIA ULTRASOUND. THE PHYSICIAN THOUGHT THAT IT WAS POSSIBLE THE FIBER MAY NOT HAVE BEEN CONNECTED TO THE TRE-SHEATH DURING LASER TREATMENT OR PERHAPS A BREAK IN FIBER THAT CAUSED THE INCIDENT. THE PROCEDURE WAS NOT COMPLETED BECAUSE THE LASER FIBER WAS WITHDRAWN INTO THE SHEATH, PREVENTING LASER EXPOSURE TO THE VEIN WALL. IT WAS THOUGHT THAT ANY TREATMENT OF CLINICAL SIGNIFICANCE WAS COMPLETED. IT WAS REPORTED THE PATIENT WAS STABLE POST EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16662514 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER EXPERIENCED AN ISSUE WHEN USING A LASER FIBER FROM A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID KIT. THE PROVIDER WAS WAS TREATING A GREATER SAPHENOUS VEIN ON A LARGE PATIENT. THE PLAN WAS TO ALSO TREAT THE SMALL SAPHENOUS VEIN. AFTER TREATING THE GSV, A MODERATE AMOUNT OF BURNT BLOOD PRODUCT WAS LEFT ON THE COPPER TIP OF THE FIBER. THE PROVIDER TOOK A PIECE OF GAUZE TO CLEAN THE TIP OF THE FIBER, AND WHEN CLEANING THE WIRE, THE TIP DETACHED. HE THEN OPENED A NEW LASER TO TREAT THE SSV. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538020 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER EXPERIENCED AN ISSUE WHEN USING A LASER FIBER FROM A NEVERTOUCH 65CM KIT W/GRIPPER AND RFID KIT. DURING AN EVLT PROCEDURE, IT WAS REPORTED THE TIP OF THE LASER DETACHED. A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537997 ↗
• MalfunctionJan 31, 2023Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  AFTER OPENING THE NEVERTOUCH LASER FIBER KIT, THEY PROCEEDED TO REMOVE THE WHITE PEEL-AWAY SPACER MOUNTED ON THE FIBER THAT LETS THE USER KNOW WHEN THE LASER FIBER TIP IS EQUAL TO THE SHEATH TIP. THE PHYSICIAN USED A SCALPEL TO HELP REMOVE THE PIECE (SPACER), INSERTED FIBER INTO THE PATIENT, AND AFTER THEY ACTIVATED THE LASER, THEY NOTED RED LIGHT EMANATING CLOSE TO WHERE THE LASER FIBER CONNECTED TO THE TRE-SHEATH. THEY STOPPED TREATMENT, OPENED ANOTHER FIBER KIT AND REPLACED THE LASER FIBER AND COMPLETED THE CASE. THE INITIAL SHEATH WAS LEFT IN PLACE SO THE NEW (SECOND) FIBER COULD BE INTRODUCED. THE END USER DID NOT NOTICE ANY DESCRIBABLE DAMAGE TO THE PRODUCT (FIBER), WITH EXCEPTION, THE FIBER TURNED RED UP BY THE SHEATH HUB AND IT NEVER DID THAT BEFORE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273416 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE PRACTITIONER REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT. DURING A LEFT LEG GSV EVLT PROCEDURE, THE PATIENT, ACCORDING TO THE DOCTOR, HAD A SUSPECTED ALLERGIC REACTION TO THE TUMESCENT MIXTURE. THE PATIENT'S FACE BECAME FLUSH AND REPORTED A TINGLING IN HER FACE, AS WELL AS A TIGHTNESS IN HER JAW AND MID TO LOWER BACK. AT THIS TIME, THE NT FIBER AND SHEATH HAD ALREADY BEEN PLACED IN THE VEIN. THE REACTION OCCURRED WITHIN 10 SECONDS OF ADMINISTERING THE TUMESCENT.THE PHYSICIAN IMMEDIATELY STOPPED THE TUMESCENT INFILTRATION AND BEGAN TO MONITOR VITAL SIGNS. THE PATIENT'S VITAL SIGNS DID NOT RETURN TO NORMAL; THEREFORE, THE PHYSICIAN ASKED FOR THEIR SUPPORT TEAM TO COME IN. THE PATIENT WAS TREATED WITH LIDOCAINE AT THE ACCESS SITE. AFTER SEVERAL MINUTES, VITALS RETURNED TO NORMAL AND THE PATIENT WAS SENT TO AN EXAM ROOM WHERE STAFF MONITORED HER FOR SEVERAL MORE MINUTES WHERE THE PATIENT WAS ADMINISTERED BENADRYL. AFTER FEELING UNWELL AGAIN, THE MEDICAL TEAM TOOK THE PATIENT TO THE EMERGENCY ROOM. UPON FOLLOW UP WITH THE NURSE PRACTITIONER, THE ANGIODYNAMICS TERRITORY MANAGER LEARNT THAT THE PATIENT WAS "GOING HOME FROM THE EMERGENCY ROOM" AND HER VITALS ARE "BACK TO BASELINE"

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16232592 ↗
• MalfunctionNov 14, 2022Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KITS W/GRIPPER AND RFID T. WHILE UNPACKING, IT WAS FOUND THAT 2 KITS HAD A "CREASE" IN THE LASER FIBER AND SHEATH. THIS CREASE HAD CAUSE THE FIBR TO FRACTURE AND THE TRE-SHEATH WAS BENT. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790302 ↗
• MalfunctionNov 14, 2022Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KITS W/GRIPPER AND RFID T. WHILE UNPACKING, IT WAS FOUND THAT 2 KITS HAD A "CREASE" IN THE LASER FIBER AND SHEATH. THIS CREASE HAD CAUSE THE FIBR TO FRACTURE AND THE TRE-SHEATH WAS BENT. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790271 ↗
• MalfunctionMay 26, 2022Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A 65CM NEVERTOUCH KIT. IT WAS REPORTED THAT THE LASER FIBER WAS PLUGGED INTO THE UNIT AND THE RED OPTICAL LASER ILLUMINATED THE FIBER, SEVERAL CENTIMETERS DOWN THE SHAFT, INDICATING A FRACTURE. ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517826 ↗
• MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A SONOGRAPHER REPORTED AN ISSUE WITH A NEVERTOUCH 65CM KIT. DURING A PROCEDURE, THE FIBER WAS USED FOR A TWO SITE ABLATION. AFTER THE FIRST ABLATION WAS COMPLETED, THE LASER WAS REMOVED TO BE GENTLY WIPED BEFORE REINSERTING. WHILE WIPING THE TIP, IT DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517708 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN EVLT PROCEDURE, THE GOLD TIP OF THE NEVERTOUCH LASER FIBER CAME LOOSE AND DETACHED FROM THE FIBER WHEN THE PHYSICIAN WAS WIPING OFF BEFORE REINSERTING INTO THE PATIENT. THIS OCCURRED OUTSIDE OF THE PATIENT; THEREFORE, THERE WAS NO HARM EXPERIENCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309870 ↗

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