Vasoview 7 XB, OUS VH-3200-WRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00607567700437), received between Sep 30, 2020 and Apr 23, 2025 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS) BIPOLAR LIGATING FORCEPS WAS UNABLE TO CAUTERIZE AND TO TRANSECT THE VEIN BRANCHES UPON INSERTION. USER SWAPPED OUT WITH A NEW SET OF VV7XB BISECTOR AND PROCEED WITH ENDOSCOPIC VEIN HARVESTING. UNEVENTFUL THEREAFTER. THERE WAS NO DELAY. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893140 ↗
• MalfunctionSep 25, 2024Fitting Problem; Fitting Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301395 ↗
• MalfunctionAug 5, 2024Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS) WAS UNABLE TO CAUTERIZE AND TO TRANSECT THE VEIN BRANCHES UPON INSERTION. IT FAILED TO CUT/TRANSECT TISSUE WHEN IT IS ALREADY CONNECTED TO THE POWER SUPPLY BOX. THEY SWAPPED OUT WITH A NEW SET OF VV7XB BISECTOR AND PROCEED WITH ENDOSCOPIC VEIN HARVESTING. UNEVENTFUL THEREAFTER. NO DELAY. NO HARM. PER VIDEO PROVIDED BY THE COMPLAINANT, THE VV7 WAS OBSERVED TO BE IN THE PATIENT'S TUNNEL, AND THE VESSEL COULD NOT BE TRANSECTED. PHOTOS WERE ALSO PROVIDED OF THE VV7. THE BLADE OF THE VV7 WAS OBSERVED TO BE ADVANCED, AND NO EVIDENCE OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906387 ↗
• MalfunctionApr 30, 2024Improper Flow or Infusion; Improper Flow or Infusion

  HOSPITAL REPORTED VASOVIEW 7 XB BISECTOR (OUS) GAS FLOW ISSUE WHEREBY THE GAS WAS NOT ABLE TO FLOW. THEY TROUBLESHOOT BY CHANGING ANOTHER INSUFFLATOR MACHINE BUT STILL NO FLOW. SUBSEQUENTLY, CHANGE ANOTHER SET AND SURGERY WENT SMOOTHLY.

  Patient problems: Insufficient Information

  MAUDE report 19213410 ↗
• MalfunctionApr 18, 2024Improper Flow or Infusion; Improper Flow or Infusion

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS) GAS FLOW HAD AN ISSUE WHEREBY THE GAS WAS NOT ABLE TO FLOW THROUGH THE CANNULA. THEY TROUBLESHOOTED BY CHANGING ANOTHER INSUFFLATOR MACHINE BUT STILL NO FLOW. SUBSEQUENTLY, CHANGE ANOTHER SET AND SURGERY WENT SMOOTHLY. THERE WAS A DELAY. NO HARM.

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

  MAUDE report 19139519 ↗
• MalfunctionDec 8, 2023Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS) KNOB IS SLANTED AND RENDER THE SAPHENOUS VEIN BRANCH CAUTERIZATION INEFFICIENT. PER THE VIDEO PROVIDED BY THE COMPLAINANT, THE BLUE TOGGLE WAS NOT STRAIGHT WHEN ADVANCING AND RETRACTING. IT WAS STILL ABLE TO CUT, HOWEVER, THE CUTTING WAS INTERMITTENT, ON AND OFF. NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO CHANGE TO A NEW SET OF VV7XB. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290579 ↗
• MalfunctionAug 7, 2023Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS) DID NOT MAKE THE CUT. IT WAS USED IN CONNECTIVE TISSUE. DID NOT DO ANYTHING. THERE WAS NO ENERGY IN THE JAWS. IT DID NOT ACTIVATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE (NEW). NO DELAY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470131 ↗
• MalfunctionApr 21, 2023Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR TIP OF THE BISECTOR IS OUT OF ALIGNMENT. THEY HAD CLOSED THE TIP BEFORE INSERTING INTO THE HARVESTER. ANOTHER VV7 BISECTOR WAS USED TO COMPLETE THE HARVESTING. THERE WAS SLIGHT DELAY TO DO THE CHANGE OUT TO A NEW BISECTOR. THERE WAS NO PATIENT EFFECTS OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788543 ↗
• MalfunctionApr 5, 2023Break; Break

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC SAPHENOUS VEIN HARVESTING PROCEDURE, THE HANDLE OF THE BISECTOR OPENED UP BY ITSELF AND A PORTION OF THE HANDLE DROPPED ON THE FLOOR. ANOTHER VV7 BISECTOR WAS USED AND PROCEDURE COMPLETED WITH NO COMPLICATION. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686187 ↗
• MalfunctionDec 7, 2022Failure to Cut; Failure to Cut

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933194 ↗
• InjuryOct 18, 2022Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem; Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR, THE VEIN GOT DAMAGED AND THROUGH THIS OPENING CO2 MIGHT HAVE ENTERED INTO THE VENOUS SYSTEM RESULTED IN INCREASED ETCO2 LEVEL. TEN MINUTES AFTER THE EVH INCISION, THE END TIDAL CO2 (ETCO2) BEGAN TO RISE PROGRESSIVELY AND PEAKED AT 88 MMOL/L. IMMEDIATE RESPONSE INCLUDED CHECKING THE VENTILATION AND SUCTIONING THE PATIENT. AN ARTERIAL BLOOD GAS (ABG) DEMONSTRATED SEVERE RESPIRATORY ACIDOSIS WITHOUT IMPAIRMENT OF OXYGENATION (PH 7.13; PACO2 87.9; PAO2 201 (FIO21); SINGLE BREATH COUNTING (SBC) 29.2 MMOL/L). IMMEDIATELY AFTER THE CESSATION OF CO2 INSUFFLATION, THERE WAS A REMARKABLE IMPROVEMENT IN THE ETCO2 THE TEMPERATURE OF THE PATIENT REMAINED NORMAL. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEPICTED NO EVIDENCE OF AIR IN THE RIGHT ATRIUM (RA) OR IN THE INFERIOR VENA CAVA. SIMILARLY, THERE WAS NO EVIDENCE OF REBREATHING OR HYPERMETABOLIC STATE SUCH AS MALIGNANT HYPERTHERMIA. A REPEAT ARTERIAL BLOOD GAS AFTER 30 MINUTES EXHIBITED A SIMILAR PICTURE. HAND VENTILATION DID NOT RESULT IN ANY SIGNIFICANT CHANGE IN THE PACO2 LEVELS. THE HEART RATE INCREASED BY 12 BEATS/MIN. BODY TEMPERATURE, HEART

  Patient problems: Insufficient Information; Respiratory Acidosis

  MAUDE report 15621453 ↗
• MalfunctionAug 31, 2022Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR FORCEPS WAS BENT. THERE WAS DIFFICULTY TO ADVANCE THE FORCEPS OUT. THE HARVESTER DECIDED TO CHANGE TO A NEW SET AND PROCEEDED WITH THE EVH PROCEDURE. THERE WAS NO HARM AS FAULTY DEVICE WAS DISCOVERED PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332354 ↗
• MalfunctionAug 31, 2022Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW 7 XB BISECTOR JAW WAS TWISTED AND PARTIALLY SECURED. WHEN INSERTING THE TOOL INTO THE HARVESTING CANNULA, THE SURGEON TRIED TO USE THE TOOL TO GRASP THE VEIN AND DISCOVERED IT WAS BENT. NO RESISTANCE WAS NOTED WHILE INSERTING THE HARVESTING TOOL INTO THE CANNULA BUT WHILE OPENING THE JAW AND TRYING TO GRASP THE VEIN, THE SURGEON WAS UNABLE TO DO SO. THERE WAS A DELAY WAITING TO OPEN A NEW DEVICE. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327378 ↗
• MalfunctionJun 14, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR (OUS), THE BIPOLAR LIGATING FORCEPS WERE WIDER THAN NORMAL AND CANNOT HOLD THE VESSEL TIGHTLY. THEY OPENED ANOTHER UNIT OF VV7 AND FINISHED THE SURGERY. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685138 ↗
• MalfunctionMar 4, 2022Crack; Crack

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR (OUS), THE SHORT PORT BLUNT TIP TROCAR (BTT) WAS DISCOVERED TO BE CRACKED WHEN OPENED THE VV7. THEY OPENED ANOTHER UNIT OF VV7 AND FINISHED THE SURGERY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673689 ↗
• MalfunctionSep 10, 2021Improper Flow or Infusion; Improper Flow or Infusion

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455304 ↗
• MalfunctionJun 22, 2021Sparking; Sparking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046956 ↗
• MalfunctionDec 17, 2020Fitting Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR (OUS), NOT ABLE TO FIX THE VASOVIEW 7CANNULA INSIDE THE ENDOSCOPE. ONLY ONE LENGTH VEIN IS REQUIRED PA MANAGED TO TOOK ONE LENGTH VEIN WITH SAME VASOVIEW 7. CANNULA DIFFICULT TO INSERT, SCOPE DID NOT RETRACT. CABG-OUTCOME-SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11027659 ↗
• InjuryDec 10, 2020Particulates; Particulates

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR (OUS). THE USER DISCOVERED 1 WHITE FRAGMENT BY LOOKING AT THE CAMERA DISPLAY. THE WHITE FRAGMENT WAS FOUND INSIDE PATIENT'S LEG, AND THEY USED TOOLS TO REMOVE (DETAILS NOT SURE). NO ADDITIONAL INTERVENTIONS ARE REQUIRED AND PATIENT'S CONDITION WAS GOOD. THEY TOOK OUT THE FRAGMENTS AND FINISHED THE PROCEDURE USING THE SAME VV7. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10982864 ↗
• InjurySep 30, 2020Break; Particulates; Peeled/Delaminated; Break; Particulates; Peeled/Delaminated

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW 7 XB BISECTOR(OUS),THE USER DISCOVERED 2 PIECES OF FRAGMENT BY LOOKING AT THE CAMERA DISPLAY. THEY SUSPECTED THAT INNER PARTS OF THE HARVESTING CANNULA BROKE DOWN AND WENT INTO THE TUNNEL. ONE PIECE OF THE FRAGMENT WAS THREW AWAY, ANOTHER ONE WAS KEPT AND REPORTED. THEY TOOK OUT THE FRAGMENTS AND FINISHED THE PROCEDURE USING THE SAME VV7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610902 ↗

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-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
• 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