Vasoview 7XB VH-3200Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00607567700369), received between Nov 11, 2020 and Nov 14, 2023 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K041981); 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2023No Apparent Adverse Event; No Apparent Adverse Event

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132749 ↗
• MalfunctionOct 20, 2023Electrical /Electronic Property Problem; Failure to Deliver Energy; Electrical /Electronic Property Problem; Failure to Deliver Energy

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978053 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17779900 ↗
• MalfunctionSep 5, 2023No Display/Image; No Display/Image

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686779 ↗
• MalfunctionJul 14, 2023Fitting Problem; Fitting Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324937 ↗
• MalfunctionJul 5, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE HOSPITAL REPORTED THAT THE VASOVIEW 7 XB BISECTOR (US), ACCESS PORT FOR CO2 WAS BLOCKED. IT WAS DISCOVERED WHEN HOOKING UP TO THE CO2. NO SIGN OF PHYSICAL DAMAGE OR DEGRADATION ON THE CO2 ACCESS PORT WAS REPORTED. THEY TOOK THE HAND PIECE, AND FOUND OUT IS ALSO HAD CO2 TUBING. THE DEVICE WAS NOT RE-STERILIZED PRIOR TO THIS INCIDENT. A NEW DEVICE WAS USED. NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255807 ↗
• MalfunctionJul 3, 2023Infusion or Flow Problem; Infusion or Flow Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248506 ↗
• MalfunctionFeb 20, 2023Failure to Deliver Energy; Device Remains Activated; Failure to Deliver Energy; Device Remains Activated

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402219 ↗
• MalfunctionOct 20, 2022Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW 7 XB BISECTOR FOR THE VEIN AND THE KNIFE WOULD NOT FULLY EXTEND MAKING IT IMPOSSIBLE TO GET AROUND BRANCHES OR USE IT WITHOUT DAMAGING THE VEIN. THEY INSPECTED IT AND CLEANED IT, BUT IT APPEARED THE KNIFE WAS BENT AND OFF ITS TRACK. THEY OPENED A NEW KIT FOR THE BISECTOR AND THAT ONE WORKED CORRECTLY. NO HARM OR RISK OF HARM TO THE PATIENT. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639984 ↗
• MalfunctionAug 30, 2022Electrical /Electronic Property Problem; Melted; Electrical /Electronic Property Problem; Melted

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR STOPPED WORKING AND THE PLASTIC AT THE JAWS WAS MELTED. NOTHING FELL INTO THE LEG. PATIENT WAS NOT INJURED. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325321 ↗
• MalfunctionJul 20, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR, THEY WERE TAKING VEIN ON FRIDAY AND TOWARDS THE END OF HARVESTING THEY WERE CUTTING SOME FASCIAL TISSUE TO OPEN UP THE TUNNEL AND THE BLADE GOT STUCK ON ONE OF THE PRONGS AND THEY WERE UNABLE TO GET THE KNIFE IN OR OUT. THERE WAS NO DAMAGE TO THE VEIN. NO DELAY. NO PARTS FELL OFF. DEVICE RETRIEVED TODAY. USED ANOTHER DEVICE TO COMPLETE CASE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071033 ↗
• MalfunctionMay 20, 2022Failure to Deliver Energy; Failure to Deliver Energy

  RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE,VASOVIEW 7 XB MALFUNCTIONED (CAUTERY NOT WORKING). VEIN WAS GOOD AND NO EXCESS BLEEDING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459714 ↗
• MalfunctionMar 16, 2022Inflation Problem; Inflation Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE VASOVIEW 7 XB BISECTOR, THERE WAS A PROBLEM MAINTAINING INSUFFLATION PORT WITH BTT. UNCLEAR AS TO WHAT THE ISSUE WAS.

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

  MAUDE report 13790471 ↗
• MalfunctionMar 9, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW 7 XB BISECTOR ENERGY NEVER WORKED OUT OF THE BOX. THEY REPLACED THE CORD WITH NO CHANGE, REPLACED THE BOVIE MACHINE EQUIPMENT WITH NO CHANGE. THEY THEN REPLACED THE EVH KIT AND IT WORKED FLAWLESSLY. THERE WAS NO PATIENT INJURY OR VEIN INJURY AS THE CAUTERY WAS NEVER IGNITED AS IT DIDNT WORK FROM THE BEGINNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716763 ↗
• MalfunctionFeb 14, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR BLUE BUTTON OF BISECTOR DEVICE WAS SLIDING IN A FAULTY MANNER. IT ACTUALLY WOULD NOT MOVE ON THE BISECTOR SO THEY COULD NOT OPEN OR CLOSE THE BISECTOR JAWS. A NEW VH-3200 WAS OPENED TO FINISH THE PROCEDURE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524613 ↗
• MalfunctionOct 27, 2021Mechanical Problem; Mechanical Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705693 ↗
• MalfunctionOct 22, 2021Fitting Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR (US), BROKEN/FAULTY DEVICE. NO INJURY. THEY STATED AT THE BEGINNING OF THE CASE THEY WERE SETTING UP THE EQUIPMENT AND TRIED TO PLACE THE SCOPE IN THE HARVESTING CANNULA AND IT WOULD NOT ADVANCE. WHEN THE CANNULA WAS INSPECTED, THERE WAS A PIECE OF PLASTIC OBSTRUCTING THE INSIDE OF THE CANNULA. THE DEVICE WAS REMOVED FROM THE CASE AND NOT USED. PATIENT WAS IN THE OR; HOWEVER, THE DEVICE WAS NOT USED ON THE PATIENT. THEY PULLED OUT A NEW VASOVIEW KIT AND COMPLETED THE PROCEDURE AS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681027 ↗
• MalfunctionSep 2, 2021Particulates; Particulates

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416785 ↗
• MalfunctionJul 8, 2021No Flow; No Flow

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (US) CO2 PORT DID NOT WORK. THE PORT WAS NOT ALLOWING CO2 TO FLOW THROUGH THE CANNULA. A SEPARATE 7XB KIT WAS OPENED WORKED PERFECT. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135119 ↗
• MalfunctionJul 7, 2021Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131729 ↗
• MalfunctionJun 9, 2021Electrical /Electronic Property Problem; Failure to Deliver Energy; Electrical /Electronic Property Problem; Failure to Deliver Energy

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968801 ↗
• MalfunctionApr 12, 2021Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR (US), JAWS ON THE DEVICE WERE NOT CAUTERIZING THE VESSEL WHEN THE HARVESTER WAS TRYING TO ACTIVATE THE DEVICE CAUTERY. THE SURGICAL TEAM IN THE ROOM TRIED TO SWITCH OUT THE CONNECTION FROM THE BIPOLAR UNIT BACK TO THE VASOVIEW DEVICE BUT THIS DID NOT RESOLVE THE ISSUE. NEXT, THEY TRIED TO SWITCH OUT THE FOOT PEDAL FOR A DIFFERENT ONE WHICH ALSO DID NOT RESOLVE THE ISSUE. THEY ENDED UP SWITCHING TO ANOTHER SEPARATE 7XB SCOPE AND THIS ONE WAS CAUTERIZING AS DESIGNED. THERE WAS NO HARM DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648666 ↗
• InjuryFeb 25, 2021No Flow; No Flow

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR INSUFFLATION WAS NOT WORKING. THEY SWAPPED THE PORT OUT AND STILL COULD NOT GET IT TO WORK. THEY ENDED UP DOING A OPEN VEIN HARVEST. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11377853 ↗
• MalfunctionFeb 4, 2021Poor Quality Image; Poor Quality Image

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR (US), THE C-RING WAS IN THE FIELD OF VIEW. THEY ALWAYS KEEP THE C-RING EXTENDED AND HAVE UTILIZED THE CANNULA ROTATION TECHNIQUE PREVIOUSLY BUT IT'S UNCLEAR IF IT WAS USED IN THIS SITUATION. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11279257 ↗
• MalfunctionJan 27, 2021Particulates; Particulates

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11236205 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041981. One submission often covers many models, so check the product and lot details in each record.

• Z-3270-2011 · Dec 17, 2009 · Terminated
  VASOVIEW 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting syst
• Z-3271-2011 · Dec 17, 2009 · Terminated
  VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting