Vasoview Hemopro 3 Endoscopic Vessel Harvesting System VH-6000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607567701274), received between Aug 22, 2025 and Sep 30, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. Aug 6, 2025Class IIOpen, Classified

   Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.

   Z-2636-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952877 ↗
• MalfunctionSep 23, 2026Self-Activation or Keying; Smoking

  The hospital reported that VasoView Hemopro 3 was done being used but still plugged in. It started smoking and was burning like left alone. They noticed the jaws of the hemopro 3 was burning when it was in neutral position inside the leg. She took it out immediately and circulating RN unplugged the cord and plugged it back in. As soon as the device was plugged in, the jaw was burning on its own. At this point, we decided the device was not safe to use and opened a new vasoview kit. There was nothing between the jaws that could be associated with the smoking of the tool, such as leftover gauze, fatty tissue, char, or blood. The troubleshooting steps taken were to unplug and replug the tool and then open and use a new kit. The smoke was coming from the jaws. The jaw was observed to be burning. No damage was noticed. The activation toggle was in the neutral state when the smoking and burning of the tool was noticed. The toggle was positioned inside the harvester while the tool was being held by the PA. The harvesting tool was placed in its original box and put away for the representative to pick up. There was no patient harm. An audible beep from the power supply was heard when the sm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867403 ↗
• MalfunctionSep 18, 2026Smoking

  The hospital reported that during an endoscopic vein harvesting procedure using the VasoView Hemopro 3, After completing the radial artery harvest, they unplugged and moved the Hemopro 3 kit to begin the vein harvest. They plugged the Hemopro 3 plug into the power unit. After a minute or so, the Hemopro 3 started to produce a lot of smoke. (The tips were closed and within the sheath when it began producing smoke.) The sheath is the white handle of the kit where the Hemopro3 is inserted down the shaft. The Hemopro 3 was unplugged and taken off the field. They used the same device for both the radial artery and vein harvest. they were keeping the jaws clean after moving from the radial artery to the vein harvest. the defective device was inspected prior to use. The smoke was not noticed while cauterizing the branches. Two different power supplies were used, one for the vein harvest and one for the radial artery harvest. the power supply was tested by Biomed. When smoking with no one touching it there was no sound. power supply light was on. cable LED not sure. A device pre-test (activating the device on wet gauze) was not performed prior to use on the patient. there was no resistance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817602 ↗
• MalfunctionSep 14, 2026Electrical /Electronic Property Problem

  Patient problems: Insufficient Information

  MAUDE report 50764205 ↗
• MalfunctionSep 3, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591706 ↗
• MalfunctionAug 10, 2026Intermittent Continuity

  Patient problems: Insufficient Information

  MAUDE report 50191839 ↗
• MalfunctionAug 6, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160298 ↗
• MalfunctionJul 31, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50102012 ↗
• MalfunctionAug 27, 2025Failure to Cut; Failure to Cut

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909830 ↗
• MalfunctionAug 27, 2025Burst Container or Vessel; Burst Container or Vessel

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909828 ↗
• MalfunctionAug 27, 2025Optical Obstruction; Optical Obstruction

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909825 ↗
• MalfunctionAug 22, 2025Self-Activation or Keying; Self-Activation or Keying

  THE HOSPITAL REPORTED THAT THE HEMOPRO 3 ACTIVATION TOGGLE WAS ACTIVATED UNINTENTIONALLY DURING A LEFT RADIAL ARTERY HARVEST. THE HEMOPRO 3 TOOL HANDLE WAS NOT BEING HELD AND SUPPORTED BY THE HARVESTER ALLOWING THE HEMOPRO 3 HANDLE TO DROOP DOWN AND REST ON THE CAMERA HEAD. THE ORIENTATION OF THE HANDLE WAS SUCH THAT THE ACTIVATION TOGGLE ABUTTED THE CAMERA HEAD. THIS CONTACT CAUSED THE ACTIVATION TOGGLE TO BE MOVE TO THE BACK/ACTIVATION POSITION ACTIVATING THE JAWS. THIS ACTIVATION WAS QUICKLY NOTICED BY THE HARVESTER FROM THE AUDIBLE TONE FROM POWER SUPPLY. THE HARVESTER IMMEDIATELY LIFTED THE HEMOPRO 3 HANDLE OFF OF THE CAMERA HEAD AND VERIFIED THE TOGGLE WAS IN THE CENTER/NEUTRAL POSITION WHICH STOPPED ACTIVATION. THERE WAS NO EVIDENCE OF DAMAGE OR INJURY TO THE TUNNEL OR CONDUIT. THE RADIAL ARTERY HARVEST PROCEEDED TO CONCLUSION WITHOUT DIFFICULTY AND NO EVIDENCE OF DAMAGE TO THE RADIAL ARTERY ONCE REMOVED. THE SAME KIT WAS SUBSEQUENTLY USED TO HARVEST 2 LENGTHS OF VEIN FROM THE LEFT LEG AFTER THE RADIAL WAS HARVESTED. THE VEIN HARVEST CONCLUDED WITHOUT REPEAT INCIDENCE OF UNINTENDED ACTIVATION. THERE WERE NO PROCEDURAL DELAY IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877466 ↗