Vasoview VV6 Pro VH-2400Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00607567700239), received between Dec 17, 2020 and Apr 6, 2026 — classified as 3 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (16 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 19, 2023Class IIOpen, Classified

   Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.

   Z-0210-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Failure to Deliver Energy

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795846 ↗
• MalfunctionMar 6, 2026Break

  THE HOSPITAL REPORTED THAT DURING ENDOSCOPIC VEIN DISSECTION USING THE VASOVIEW 6 PRO, THE BISECTOR TOGGLE BROKE OFF AFTER SEVERAL MINUTES OF USE. THE EVENT OCCURRED WITHOUT ANY FORCED MOVEMENT, DROP, OR IMPACT. THE BISECTOR TOGGLE SUBSEQUENTLY DISENGAGED AND FELL OUT OF THE BISECTOR CARRIAGE WITHOUT THE APPLICATION OF FORCE. A NEW DEVICE WAS OPENED TO FINISH THE CASE. THERE WAS A 10 MINUTE DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536134 ↗
• MalfunctionJan 21, 2026Failure to Cut

  THE HOSPITAL REPORTED THAT CUTTER BLADE OF VASOVIEW 6 PRO WAS MALFUNCTIONING. SECOND DEVICE WAS USED TO FINISH CASE. THERE WAS NO PATIENT HARM. NO PROCEDURE DELAY. NO PARTS WERE LEFT BEHIND IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128534 ↗
• MalfunctionDec 29, 2025Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING THE PROCEDURE, THE BIPOLAR COAGULATION FUNCTION OF THE VASOVIEW 6 PRO WAS NOT OPERATIONAL. THE BIPOLAR BURNER DID NOT FUNCTION DESPITE REPLACEMENT OF THE CONNECTION CABLE. AFTER THE CABLE WAS REPLACED AND ITS FUNCTIONALITY WAS VERIFIED AWAY FROM THE PATIENT, IT WAS NECESSARY TO OPEN A NEW KIT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908439 ↗
• MalfunctionDec 11, 2025Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780911 ↗
• MalfunctionSep 2, 2025Failure to Cut; Failure to Cut

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938544 ↗
• MalfunctionAug 14, 2025Failure to Cut; Insufficient Device Problem Information; Failure to Cut; Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT DURING PROCEDURE USING VASOVIEW 6 PRO, "THE PIECE THAT GRABS THE VEIN WOULDN'T ENGAGE." THEY COULD NOT SEE IT EITHER. THERE WAS NO DELAY, A NEW DEVICE WAS OPENED. NO CONSEQUENCE FROM THE EVENT. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806365 ↗
• InjuryJun 20, 2025Self-Activation or Keying; Self-Activation or Keying

  THE HOSPITAL REPORTED THAT THE PATIENT HAD A SMALL EXTERNAL BURN ON SKIN FROM THE VASOVIEW 6 PRO THAT OCCURRED WHICH SEALING A BRANCH DURING CASE. THE DEVICE STAYED ACTIVATED WHILE ENDOSCOPICALLY HARVESTING VEIN. DEVICE WAS TURNED OFF AND SEPARATED WITH OTHER VEIN INSTRUMENTS ON THE BACK TABLE AT THE END OF VEIN HARVESTING FOR BYPASS. THE PROCEDURE WAS COMPLETED PRIOR TO BURN DISCOVERY. BURN WAS DISCOVERED AT THE END OF THE PROCEDURE WHEN IOBAN WAS REMOVED. THE PATIENT EXPERIENCED A FIRST-DEGREE BURN. THERE WAS NO PROCEDURAL DELAY. PATIENT IS IN CRITICAL BUT STABLE CONDITION. ISSUE DISCOVERED AFTER CASE WAS FINISHED AND CASE TRASHED HAD ALREADY BEEN TAKEN OUT.

  Patient problems: Burn(s)

  MAUDE report 22298358 ↗
• MalfunctionMay 21, 2025Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO BIPOLAR COAGULATION WAS DEFECTIVE. WHEN USING THE COAGULATION ROD OF THE VASOVIEW 6 PRO FOR THE FIRST TIME, THEY ALWAYS TEST IT ON A PIECE OF FAT TO CHECK WHETHER THE BIPOLAR CLAMP WORKS OR NOT. THIS DID NOT WORK. THEN THEY ASKED FOR ANOTHER BIPOLAR CABLE TO SEE IF THIS WAS THE CAUSE. BUT IT STILL DID NOT WORK. THEN THEY ASKED THE CIRCULATING NURSE TO PULL THE PLUG OF THE BIPOLAR CABLE AND TURN IT AROUND, BUT IT STILL DID NOT WORK. THEN THEY DECIDED IN CONSULTATION WITH THE SURGEONS TO GIVE ANOTHER VASOVIEW 6 PRO. THE BIPOLAR DID WORK ON THE NEW ONE. THE PATIENT DID NOT SUFFER ANY DAMAGE OR INJURIES, BUT THERE IS VALUABLE TIME WAS LOST BECAUSE OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063411 ↗
• MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909808 ↗
• MalfunctionMar 21, 2025Break; Break

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO C-RING WAS DETACHED FROM ONE OF THE ARMS. THEY OPENED A NEW DEVICE. THERE WAS A 5 MINUTE DELAY. NO HARM TO THE PATIENT. NO PARTS LEFT BEHIND .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21666805 ↗
• MalfunctionMar 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT DURING A SAPHENOUS ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW 6 PRO WOULD NOT DELIVER ENERGY TO CAUTERIZE BRANCH. HE WAS 75% DONE PROCEDURE. DEVICE WAS WORKING PROPERLY UNTIL IT STOPPED WORKING. HE REMOVED DEVICE AND VISUALLY INSPECTED THE CUTTING TOOL. HE NOTED DAMAGE TO THE TOOL. THE TOOL WAS SPLIT AT THE TIP. NO POWER SUPPLY ISSUE. THERE IS NO EXTENSION CORD OR ADAPTER USED WITH THIS PRODUCT. HE STOPPED USING THE KIT AND OPENED AN ADDITIONAL KIT TO COMPLETE THE CASE. THERE WAS NOT ANY HARM TO PATIENT OR STAFF. THERE WAS NOT ANY PIECE OF THE KIT RETAINED IN THE PATIENT. HE DID NOT HAVE TO MODIFY PROCEDURE TO COMPLETE THE CASE. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620294 ↗
• MalfunctionJan 17, 2025Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT THE CAUTERY WOULDN'T WORK ON DEVICE. TRADED OUT CORDS AND TROUBLESHOOTED. NEW DEVICE FUNCTIONED. SLIGHT DELAY IN CASE DUE TO TROUBLESHOOTING AND REPLACEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185111 ↗
• MalfunctionDec 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO2 (VH-4000) DEVICE NOT WORKING, TRIED TWO DIFFERENT CORDS AND STILL DIDN'T WORK; DEVICE WOULD NOT TURN ON WHEN ACTIVATED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PROCEDURAL DELAY. NO PATIENT HARM/EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028232 ↗
• MalfunctionDec 13, 2024Break; Break

  THE HOSPITAL REPORTED THAT WHILE TESTING THE DEVICE VASOVIEW 6 PRO, BEFORE GOING INTO THE PATIENT, THE ENTIRE "C" RING ASSEMBLY BECAME DETACHED FROM THE HARVESTING CANNULA. THEY ATTEMPTED TO RE-INSERT THE "C" RING ASSEMBLY BACK INTO THE HARVESTING CANNULA WITH NO SUCCESS. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WERE NO KNOWN PATIENT HARM/EFFECTS. NO PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931815 ↗
• MalfunctionDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL REPORTED PRODUCT FAILURE FOR VASOVIEW 6 PRO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902814 ↗
• MalfunctionDec 6, 2024Improper Flow or Infusion; Improper Flow or Infusion

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO CO2 PORT WAS NOT WORKING PROPERLY. GAS SUPPLY (CO2) CONNECTION SEEMS CLOSED. AS A RESULT, NO CO2 CAME THROUGH THE PLUG. AFTER MUCH SEARCHING WHERE THE PROBLEM WAS, IT TURNED OUT TO BE THE SOLUTION AFTER TAKING A NEW PLUG (FROM A LOOSELY PACKED ACCESSORY PACK). NO HARM TO THE PATIENT. THERE WAS A DELAY OF ABOUT 10 MINUTES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871324 ↗
• MalfunctionNov 26, 2024Break; Break

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, VASOVIEW 6 PRO -C-RING BECAME DETACHED FROM THE HARVESTING CANNULA DURING USE. NO PIECES BROKE OFF IN PTS LEG. A NEW KIT WAS OPENED TO COMPLETED THE PROCEDURE. THERE WAS A DELAY TO OPEN NEW KIT. NO INJURY TO PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780825 ↗
• MalfunctionSep 24, 2024Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW 6 PRO KNIFE DID NOT CUT PROPERLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5-MINUTE DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291760 ↗
• MalfunctionSep 6, 2024Mechanical Problem; Mechanical Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157161 ↗
• MalfunctionAug 6, 2024Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO ONE OF THE WIRE TIPS WAS BENT. THIS PREVENTED THEM FROM CUTTING AND CAUTERIZING PROPERLY. THEY PULLED ANOTHER ONE OFF THE SHELF AND COMPLETED THE CASE SUCCESSFULLY. PATIENT WAS NOT HARMED NOR WAS THERE ANY TIME ADDED TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919452 ↗
• MalfunctionJul 15, 2024Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  THE HOSPITAL REPORTED VASOVIEW 6 PRO COAGULATION THAT DID NOT WORK.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741594 ↗
• MalfunctionJul 5, 2024Contamination; Contamination

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO BLACK HAIR WAS SEALED IN THE STERILE PACKAGING, BUT BECAUSE THE PACKAGING WAS REFLECTIVE, IT WAS NOT IMMEDIATELY NOTICEABLE (YOU HAVE TO LOOK VERY CLOSELY TO SEE IT!). VASOVIEW WAS USED NORMALLY/STANDARDLY FOR THE PROCEDURE. PER PHOTO PROVIDED BY THE COMPLAINANT, IT IS OBSERVED THERE IS A PIECE OF HAIR ON THE PLASTIC TRAY.

  Patient problems: Insufficient Information

  MAUDE report 19680885 ↗
• MalfunctionJun 14, 2024Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO KNIFE DOES NOT CUT SUFFICIENT. THE JAWS FAILED TO CUT/TRANSECT TISSUE. OPENED SECOND DEVICE. NO DELAY. NO HARM FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538581 ↗
• MalfunctionJun 13, 2024Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO COAGULATION DIDN'T WORK. TRIED ANOTHER CABLE BUT NO EFFECT. THEY TOOK A NEW VASOVIEW ON THE TABLE AND THE COAGULATION WORKED. THERE WAS SOME DELAY IN THE PROCEDURE DUE TO HAVING TO LOOK FOR THE PROBLEM. THE PATIENT SUFFERED NO HARM FROM THIS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529149 ↗