Vasoview EVH Accsessory Pack VH-2004Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00607567700376), received between Feb 25, 2021 and Nov 13, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (7 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Defective Component; Defective Component

  PRIOR TO START OF PROCEDURE, THE PURPLE DISSECTION TIP WAS REMOVED FROM KIT AND IT WAS NOTICED THAT THE TIP WAS NOT SMOOTH AND APPEARED TO HAVE RIDGES. PICTURE WAS PROVIDED BY HOSPITAL. THE TIP WAS NOT USED FOR PROCEDURE, A NEW ACCESSORY KIT WAS OPENED. TIP WAS DISCARDED BY ACCOUNT. PATIENT INFORMATION N/A AS IT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543677 ↗
• InjuryJan 31, 2025Peeled/Delaminated; Environmental Particulates; Peeled/Delaminated; Environmental Particulates

  N/A.

  Patient problems: Foreign Body In Patient

  MAUDE report 21285279 ↗
• MalfunctionJan 13, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, CO2 WOULD NOT FLOW THROUGH THE BTT OF THE VV 6 ACCESSORY PACK (VH-2004). PATIENT WAS NOT INJURED. NO TIME WAS ADDED TO THE CASE. A NEW (BTT) WAS USED TO COMPLETE THE PROCEDURE AND THE SAME VV6 WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143117 ↗
• MalfunctionJan 9, 2025Improper Flow or Infusion; Improper Flow or Infusion

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118527 ↗
• MalfunctionOct 28, 2024Improper Flow or Infusion; Improper Flow or Infusion

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VV 6 ACCESSORY PACK INSUFFLATOR WOULD NOT HOLD PRESSURE INSIDE THE PATIENT AND THE VEINS COULD NOT BE VISUALIZED. OPEN VEIN HARVESTING WAS DONE.

  Patient problems: Insufficient Information

  MAUDE report 20543474 ↗
• MalfunctionOct 7, 2024

  THE VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM'S INSUFFLATOR WOULD NOT HOLD PRESSURE INSIDE THE PATIENT AND THE VEINS COULD NOT BE VISUALIZED. OPEN VEIN HARVESTING WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383054 ↗
• MalfunctionSep 30, 2024Contamination /Decontamination Problem; Environmental Particulates; Contamination /Decontamination Problem; Environmental Particulates

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334337 ↗
• MalfunctionApr 8, 2024Improper Flow or Infusion; Improper Flow or Infusion

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061066 ↗
• MalfunctionApr 8, 2024Improper Flow or Infusion; Improper Flow or Infusion

  RELATED TO (B)(6). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VV 6 ACCESSORY PACK BTT EXCHANGED FOR A NEW ONE VIA ACCESSORY KIT, CO2 STILL NOT FLOWING. CO2 TUBING EXCHANGED FOR NEW. STILL NO FLOW. ANOTHER BTT OPENED VIA ACCESSORY KIT. AFTER PROCEDURE THEY TRIED TO TROUBLE SHOOT AND WAS NOT ABLE TO DUPLICATE THE ISSUE. PROCEDURE COMPLETED WITH ORIGINAL HP2 DEVICE AND THE LAST OPENED BTT. MINIMAL PROCEDURE DELAY DUE TO TROUBLESHOOTING ISSUE. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059675 ↗
• InjuryApr 3, 2024Improper Flow or Infusion; Improper Flow or Infusion

  N/A

  Patient problems: Insufficient Information

  MAUDE report 19037575 ↗
• MalfunctionMar 6, 2024Improper Flow or Infusion; Improper Flow or Infusion

  RELATED TO: (B)(4). THE HOSPITAL REPORTED THAT DURING ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 READ "OCCLUSION" WHEN IT WAS PLUGGED INTO CO2 INSUFFLATION. HARVESTER TRIED NEW INSUFFLATION TUBING WITH NO SUCCESS. WITH NO INSUFFLATION, SURGICAL ASSISTANT COULD NOT CONTINUE WITH LAPAROSCOPIC APPROACH AFTER MULTIPLE ATTEMPTS WITH TWO DIFFERENT HARVESTERS. NEW TOWER WITH INSUFFLATION WAS ATTEMPTED WITH NO SUCCESS EITHER.

  Patient problems: Insufficient Information

  MAUDE report 18844816 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VV 6 ACCESSORY PACK BALLOON ON THE BTT POPPED. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. ONLY DELAY WAS TO OPEN A NEW KIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183177 ↗
• MalfunctionNov 16, 2021Material Rupture; Material Rupture

  RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VV 6 ACCESSORY PACK, THE BALLOON ON THE BTT ON THE VASOVIEW 3500 KIT SPONTANEOUSLY BURST. NO INJURY OR HARM TO THE PATIENT. THE CASE WAS COMPLETED WITH AN ADDITIONAL BTT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820762 ↗
• MalfunctionNov 16, 2021Material Rupture; Material Rupture

  RELATED TO TW (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819447 ↗
• InjuryFeb 25, 2021No Flow; No Flow

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING PORT FROM VV 6 ACCESSORY PACK. INSUFFLATION WAS NOT WORKING. THEY SWAPPED THE PORT OUT AND STILL COULD NOT GET IT TO WORK. THIS IS THE SECOND PORT THAT THEY COULD NOT GET CO2 INSUFFLATION TO FLOW THROUGH THE PORT. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11378340 ↗