VenaCure EVLT 11403001Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI H787114030010), received between Apr 26, 2016 and Sep 2, 2025 — classified as 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Fracture; Fracture

  EVENT DESCRIPTION CORRECTION: AN FDA MEDSUN PROGRAM REPORT WAS RECEIVED VIA EMAIL WHICH REPORTED THAT AN END-USER FACILITY EXPERIENCED AN ISSUE WITH A "NEVERTOUCH 45CM KIT W/GRIPPER AND RFID T' DEVICE. DURING A PATIENT'S RIGHT ACCESSORY SAPHENOUS VEIN ENDOVENOUS LASER ABLATION (EVLA) PROCEDURE, THE FIBER FRACTURED INSIDE OF THE PATIENT. THE DEVICE FRAGMENT WAS REMOVED VIA A CUT-DOWN/SNARE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE FRACTURED FIBER BURNED A HOLE THROUGH THE STERILE DRAPES ON THE STERILE FIELD AFTER IT HAD BEEN REMOVED FROM THE PATIENT. THE END-USER REPORTED THAT ALL SAFETY MEASURES WERE BEING FOLLOWING PER PROTOCOL PRIOR TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22942935 ↗
• MalfunctionAug 13, 2025Fracture; Use of Device Problem

  FROM STAFF: LASER FIBER BEING USED IN ABLATION CASE WAS FRACTURED AND BURNED A HOLE THROUGH THE STERILE DRAPES ON THE FIELD. PRIOR TO ALL SAFETY MEASURES WERE BEING FOLLOWED PER PROTOCOL. THE EVENT HAPPENED DUE TO A FAULTY PRODUCT AND COULD NOT HAVE BEEN PREDICTED DUE TO THE NATURE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792212 ↗
• MalfunctionAug 4, 2025Fracture; Flare or Flash; Fracture; Flare or Flash

  AN END USER REPORTED AN ISSUE WITH AN EVLT FIBER AND A VENACURE 1470 LASER UNIT . IT WAS REPORTED THE LASER UNIT BURNED THE FIBER OFF AT THE GRIPPER SECTION (FRS GRIPPER HAD CAUGHT FIRE). THE FIBER WAS INSIDE THE PATIENT AT THE TIME, AND WAS SUBSEQUENTLY REMOVED. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. THEY REQUESTED TO HAVE THE UNIT RETURNED FOR EVALUATION AND PM/CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701062 ↗
• MalfunctionFeb 28, 2024Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NEVERTOUCH 65CM FIBER KIT. WHEN PREPARING FOR AN EVLT PROCEDURE, THE FIBER WAS OBSERVED TO BE BENT WHEN IT WAS REMOVED FROM THE PACKAGING. A NEW OF THE SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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 18800715 ↗
• MalfunctionJul 17, 2023Fracture; Fracture

  DURING PREPARATION , AND PRIOR TO PLACING THE NEVERTOUCH 45CM FIBER INTO THE PATIENT, IT WAS NOTED THAT THERE WAS A HOLE/CRACK IN THE LASER CATHETER WHERE THE RED LIGHT SHONE THROUGH. THE FIBER WAS PLACED ASIDE AND A NEW OF THE SAME KIT WAS OPENED TO COMPLETE THE PROCEDURE. 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 17334296 ↗
• MalfunctionFeb 17, 2022Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A NEVERTOUCH 45CM KIT. WHILE OPENING THE KIT FOR A PROCEDURE, THE DOCTOR NOTED THAT THE LASER FIBER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER KIT. 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 13549904 ↗
• MalfunctionFeb 1, 2021Fracture; Fracture

  A SENIOR SAFETY SPECIALIST REPORTED A USER FACILITY MEDWATCH FOR AN ISSUE WITH A NEVERTOUCH 45CM KIT. THE REFERENCE NUMBER ON THE FORM WAS NOTED AS (B)(4). THE FOLLOWING WAS REPORTED: "WHILE USING A VENACURE 1470 LASER, THE DISPOSABLE LASER SHEATH BROKE. THIS MAY HAVE POSSIBLY BROKE WHEN THE LASER COULD HAVE BEEN FIRED WHILE IT WAS STILL IN THE SHEATH. THE SURGEON MADE AN UNPLANNED INCISION TO RETRIEVE THE DISTAL TIP (10CM) OF THE LASER SHEATH. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11259508 ↗
• MalfunctionJan 17, 2021Fracture; Fracture

  1ST FIBER: AN ANGIODYNAMICS TM REPORTED AN END USER EXPERIENCED AN ISSUE WITH A NEVERTOUCH LASER FIBER. THE CUSTOMER REPORTED THAT THEY RECEIVED TWO LASER KITS THAT WHERE DEFECTIVE /DAMAGE ONE WAS KINKED VERY SEVERELY AND THE OTHER WAS CUT. BOTH KITS WERE OPENED FOR THE SAME PATIENT/PROCEDURE. IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182947 ↗
• MalfunctionJan 17, 2021Fracture; Fracture

  2ND FIBER: AN ANGIODYNAMICS TM REPORTED AN END USER EXPERIENCED AN ISSUE WITH A NEVERTOUCH LASER FIBER. THE CUSTOMER REPORTED THAT THEY RECEIVED TWO LASER KITS THAT WHERE DEFECTIVE /DAMAGE ONE WAS KINKED VERY SEVERELY AND THE OTHER WAS CUT. BOTH KITS WERE OPENED FOR THE SAME PATIENT/PROCEDURE. IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182946 ↗
• InjurySep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A CATHETER. DURING A PROCEDURE, WHEN THE CATHETER WAS REMOVED, THERE WAS A CONCERN THAT THE LASER HAD SLIPPED BACK INTO THE CATHETER AS THE CATHETER TIP WAS NO LONG VISIBLE/ PRESENT. AT THIS TIME, THE PHYSICIAN FELT THAT THERE WAS NO RISK OF EMBOLIZATION. THE FOREIGN BODY WAS DISCUSSED WITH THE PATIENT AND A FOLLOW UP APPOINTMENT WAS MADE. DURING THE FOLLOW UP APPOINTMENT ON (B)(6) 2020, A SCAN WAS CONDUCTED OF THE PATIENT'S RIGHT LEG AND THE FOREIGN BODY WAS VISUALIZED. THE DOCTOR OPENED THE PATIENT'S LEG AND REMOVED THE CATHETER TIP ON (B)(6) 2020. THE PATIENT HAS BEEN REPORTED AS "STABLE." IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10572872 ↗
• MalfunctionFeb 21, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED: CUSTOMER REPORTED THAT THE STERILE PACKAGING SEAL WAS BROKEN AND THEREFORE COULDN'T BE USED. 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. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 9740976 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: CLOT REPORTED UPON PLACEMENT OF GUIDEWIRE AND SHEATH. LASER FIBER WAS NOT INSERTED YET. CUSTOMER PULLED OUT WIRE AND SHEATH TO TERMINATE PROCEDURE AND PULLED OUT 6 INCH OF CLOT. THIS HAS HAPPENED 3 TIMES IN A ROW (LATE DECEMBER, COMPLAINTS WERE FILED). DR. (B)(6) SAID HE CONFIRMED THERE WAS NO CLOT IN THE SEGMENT PRIOR TO GAINING ACCESS TO VEIN. HE DID MENTION ONE OF THE PATIENT'S TESTED POSITIVE FOR FACTOR 5. ON 1/29, (ANGIODYNAMICS' REPORTING REPRESENTATIVE) WENT TO THEIR NEXT VEIN CLINIC DAY TO CONFERENCE IN CLINICAL SPECIALISTS, DR. (B)(6), AND DR. (B)(6). WE DISCOVERED PRACTICE WAS FLUSHING WITH THE TUMESCENT SOLUTION INSTEAD OF SALINE. DR. (B)(6) AND DR. (B)(6) SHARED THEIR PROFESSIONAL OPINION. DR. (B)(6) AND DR. (B)(6) TREATED TWO DIFFERENT PATIENTS THAT THE PRACTICE AND NO PROBLEMS CAME ABOUT. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Thrombus

  MAUDE report 9700653 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED : A SMALL CLOT ADVANCED OUTSIDE OF THE SHEATH WHEN ADVANCING FIBER. THEY FLUSHED THE SHEATH AND DILATOR AND GUIDEWIRE. CLOT MIGRATED INTO DEEP SYSTEM. THERE WAS CLOT ON THE FIBER ONCE THEY PULLED FIBER OUT OF BODY. PHYSICIAN PRESCRIBED XALRETO AND WILL CONTINUE TO FOLLOW UP WITH PATIENT. THEY SAVED THE FIBER. (PATIENT 1). A SIMILAR INCIDENCE HAPPENED TO ANOTHER PATIENT THE FOLLOWING MORNING WITH DR. (B)(6) (PATIENT 2, REFERENCE 1319211-2020-00002). PATIENT WAS REPORTED AS BEING STABLE POST PROCEDURE. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Thrombus

  MAUDE report 9582007 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED : A SMALL CLOT ADVANCED OUTSIDE OF THE SHEATH WHEN ADVANCING FIBER. THEY FLUSHED THE SHEATH AND DILATOR AND GUIDEWIRE. CLOT MIGRATED INTO DEEP SYSTEM. THERE WAS CLOT ON THE FIBER ONCE THEY PULLED FIBER OUT OF BODY. PHYSICIAN PRESCRIBED XALRETO AND WILL CONTINUE TO FOLLOW UP WITH PATIENT. THEY SAVED THE FIBER. (PATIENT 1) A SIMILAR INCIDENCE HAPPENED TO ANOTHER PATIENT THE FOLLOWING MORNING WITH DR. (B)(6) (PATIENT 2, REFERENCE 1319211-2020-00002). PATIENT WAS REPORTED AS BEING STABLE POST PROCEDURE. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Thrombus

  MAUDE report 9581372 ↗
• MalfunctionDec 10, 2019Fracture; Fracture

  AS REPORTED : DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS 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. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9446223 ↗
• MalfunctionNov 13, 2019Fracture; Fracture

  DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS BENT/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. 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 9315196 ↗
• MalfunctionOct 11, 2019Fracture; Fracture

  A SAMPLE WAS RECEIVED ON AUGUST 12 2019. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO IDENTIFY THE COMPLAINT RECORD FOR THE RETURNED SAMPLE. THE RETURN LABEL ON THE PACKAGE CONTAINED A PHONE NUMBER, WHICH WAS CALLED. SEVERAL MESSAGES WERE LEFT, BUT NO RESPONSE WAS RECEIVED. THIS COMPLAINT FILE WAS OPENED TO DOCUMENT THE RETURNED DEVICE USING THE ACCOUNT NAME ON THE RETURN LABEL. THE DEVICE WAS OPENED FOR EVALUATION ON (B)(6), AT WHICH TIME IT WAS NOTED THE FIBER WAS FRACTURED. AS IT CANNOT BE DETERMINED OF THE FRACTURE OCCURRED AT THE USER FACILITY OR DURING SHIPPING TO ANGIODYNAMICS FOR EVALUATION OF AN UNKNOWN ISSUE, THIS PR HAS BEEN DEEMED REPORTABLE AS A PRECAUTION. THE AWARE DATE FOR THIS DEVICE WILL BE BASED ON (B)(6) 2019 AS THIS IS THE DATE THE FRACTURE WAS NOTED. SAMPLE EVALUATION DESCRIPTION: THE FIBER IS BENT/FRACTURED MEASURED AT 84CM FROM TIP END AND THE LASER SHOWS THE SAMPLE WAS FIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179287 ↗
• MalfunctionSep 12, 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 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. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9009744 ↗
• MalfunctionSep 25, 2018Unraveled Material; Unraveled Material

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING AN EVLT PROCEDURE, WHEN INSERTING THE GUIDEWIRE INTO THE CATHETER, THE GUIDEWIRE UNRAVELED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT HARMED OR INJURED 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 7907016 ↗
• MalfunctionJun 26, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON MAY 31, 2018: NEARING END OF AN EVLT TREATMENT PROCEDURE, THE USER REPORTED THEY STARTED TO SMELL A BURNING ODOR. AS THE TREATING PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT, THE TIP OF THE CATHETER APPEARED TO BE BURNT. THE FIBER WAS LOCKED INTO PLACE WITH THE CATHETER. AS THE CATHETER WAS UNLOCKED AND THE FIBER WAS REMOVED, THE TIP OF THE CATHETER BROKE OFF. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THIS EVENT AS THE DEVICE HAD BEEN REMOVED AT THE TIME OF 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 7638941 ↗
• MalfunctionJun 5, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED TO ANGIODYNAMICS ON MAY 08. 2018: THE TREATING PHYSICIAN WITHDREW THE FIBER AND THE SHEATH FROM THE PATIENT AS ONE UNIT. WHEN DISASSEMBLING IN ORDER TO FLUSH AND CLEAN IT, THE TIP OF THE FIBER APPEARED TO BE STUCK INSIDE OF THE SHEATH. IT WAS NOTED THE TIP HAD MELTED TO THE INSIDE OF THE SHEATH. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHA NEW OF THE SAME DEVICE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS 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 7569888 ↗
• MalfunctionMar 13, 2018Continuous Firing; Continuous Firing

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: IT WAS REPORTED THAT THEN THE FIBER HAD BEEN WITHDRAWN FROM THE PATIENT, THE FIBER CONTINUED TO FIRE EVEN AFTER THE FOOT PEDAL WAS DISENGAGED. THE TREATING PHYSICIAN TAPPED THE FOOT PEDAL TO ENSURE THE SWITCH WAS NOT STUCK. THE FIBER CONTINUED TO FIRE FOR APPROXIMATELY 4 SECONDS BEFORE THE LASER UNIT DISPLAYED "FIBER INVALID." THE FIBER WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM AS THE EVENT OCCURRED OUTSIDE OF THE PATIENT. 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 7334820 ↗
• MalfunctionMar 1, 2018Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018, DURING THE EVLT PROCEDURE, THE FIBER AND SHEATH WERE WITHDRAWN FROM THE PATIENT AS ONE UNIT. WHEN THE PHYSICIAN WAS PREPARING TO TREAT THE PATIENT'S SECOND VEIN, IT WAS NOTED THE GOLD TIP OF THE LASER FIBER HAD DETACHED INSIDE OF THE SHEATH. AS THE TIP WAS INSIDE OF THE SHEATH, THE PATIENT SUFFERED NO ADVERSE EFFECTS 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 7305636 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON NOVEMBER 29, 2017: IT WAS REPORTED THAT AN 80+ YEAR OLD FEMALE WAS SCHEDULED FOR A VEIN ABLATION PROCEDURE. DURING THE ABLATION, 1.5L OF TUMESCENT ANESTHESIA WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF DEVICE MALFUNCTION OR PATIENT COMPLICATION. AFTER THE ABLATION, THE PATIENT WAS NON-RESPONSIVE AND HAD TO PHYSICALLY BE AWAKENED. AFTER BEING AWAKENED, THE PATIENT SHOWED SIGNS THAT WERE CONCERNING TO THE STAFF (SLUGGISH, VOMITING, DRY HEAVING, CONFUSION). STAFF MONITORED PATIENT FOR SEVERAL HOURS AND THEN PATIENT WENT BY AMBULANCE TO THE ER. IT WAS REPORTED THE DISPOSABLE DEVICE USED DURING THE PROCEDURE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: Patient Problem/Medical Problem; Reaction

  MAUDE report 7133262 ↗
• MalfunctionDec 20, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING AN EVLT PROCEDURE, IT WAS NOTED THE FIBER STOP ON THE FIBER SHAFT WAS SLIDING FREELY. THIS WAS NOTICED PRIOR TO INSERTION OF THE PATIENT'S SSV. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS 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 7133261 ↗

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