HemoPro 2 Adaptor C-VH-4020Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00607567700918), received between Aug 23, 2020 and Sep 14, 2026 — classified as 3 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (38 reports).

10 other recalls cover devices cleared under the same FDA submission (K101274); 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Failure to Deliver Energy

  The hospital reported prior to use that there is an issue with the HemoPro2 Adaptor. The device does not supply enough power for cauterization. No risk to patients. The HemoPro2 Adaptor between the pliers and the power supply had a loose connection. This caused the caulking pliers to lose power. The cable was replaced by the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753781 ↗
• MalfunctionApr 29, 2026Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT HEMOPRO2 ADAPTOR WAS NOT WORKING - NO POWER/ENERGY. CHANGED TO ANOTHER HEMOPRO2 ADAPTOR TO COMPLETE CASE. HAPPENED DURING CASE IN SURGERY. NO PATIENT EFFECTS OR DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034763 ↗
• MalfunctionMar 24, 2026Failure to Deliver Energy

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673101 ↗
• MalfunctionMar 17, 2026Failure to Deliver Energy

  RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING THE PROCEDURE, THE POWER STOPPED WORKING IN THE HEMOPRO 2 ADAPTOR. THERE WAS NO HARM. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618569 ↗
• MalfunctionFeb 25, 2026Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT T.W. POWER SUPPLY QUIT WORKING DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441638 ↗
• MalfunctionJan 29, 2026Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, HEMOPRO2 ADAPTOR WAS BROKEN AND NOT WORKING. USED SAME ONE TO COMPLETE CASE. NO HARM, OR DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207967 ↗
• MalfunctionJan 8, 2026Failure to Deliver Energy

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001690 ↗
• MalfunctionJan 8, 2026Connection Problem

  THE HOSPITAL REPORTED THAT THE HEMOPRO2 ADAPTOR DOES NOT ALWAYS REMAIN CONNECTED TO THE HEMOPRO POWER SUPPLY AND, IN SOME CASES, REQUIRES TAPING TO ENSURE CONSISTENT ENERGY DELIVERY TO THE VASOVIEW HEMOPRO 2. THE ISSUE HAPPENED DURING THE PROCEDURE. THERE WAS A DELAY.

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

  MAUDE report 24001688 ↗
• MalfunctionNov 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622416 ↗
• MalfunctionOct 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, HEMOPRO2 ADAPTOR WAS NOT WORKING CORRECTLY. RANDOMLY START AND STOP WORKING. SWITCHED BOTH AND FINISHED CASE. THE TROUBLESHOOTING STEPS TAKEN WERE TURNED POWER SUPPLY ON/OFF, UNPLUGGED THE RE-PLUGGED CABLES. FINISHED CASE WITH NO HARM OR ISSUES WITH PATIENT. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437738 ↗
• InjurySep 2, 2025Connection Problem; Connection Problem

  THE HOSPITAL REPORTED THAT DURING A SURGERY, A DEVICE FAILED INTRAOPERATIVELY. IT WAS PART OF THE "ENDOSCOPIC VEIN HARVESTING" HEMOPRO2 ADAPTOR FROM GETTINGE. THE VASOVIEW HEMOPRO2. THE DEVICE, ALONG WITH CONSUMABLES, IS SUITABLE FOR HARVESTING VESSELS MINIMALLY INVASIVELY/ENDOSCOPICALLY FOR CARDIAC BYPASS SURGERY. AFTER THE PROCEDURE BEGAN, IT TURNED OUT THAT A POWER GENERATOR FOR THE DIATHERMY WAS MALFUNCTIONING. AFTER TROUBLESHOOTING, BOTH THE CONSUMABLES AND OUR INSTRUMENT TRAY WERE RULED OUT AS THE CAUSE. THE SOURCE OF THE PROBLEM TURNED OUT TO BE A PERMANENT CABLE CONNECTION FOR THE DIATHERMY, WHICH HAD APPARENTLY BEEN HASTILY GLUED ON THE DEVICE SIDE WITH A HOT GLUE GUN. THIS RESULTED IN A LOOSE CONNECTION AND THUS THE DEVICE'S FAILURE. COAGULATION NOT POSSIBLE BECAUSE THE CABLE IS DEFECTIVE. THERE WAS NO PRE-TEST DONE WITH THE DEVICE. PER PHOTOS PROVIDED BY THE COMPLAINANT, IT IS OBSERVED THE ADAPTOR IS DETACHED. OPEN SAPHENOUS VEIN HARVEST FROM THE UPPER RIGHT THIGH THE PATIENT SUFFERED INJURIES BECAUSE THE ACCESS ROUTE HAD TO BE WIDENED, NECESSITATING AN ADDITIONAL LONG SKIN INCISION. THERE WAS NO BLOOD TRANSFUSION, BUT THE VEIN IN THE THIGH HAD TO BE HARVESTED USING OPEN

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

  MAUDE report 22943854 ↗
• MalfunctionJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 22644495 ↗
• MalfunctionMay 16, 2025Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO2 ADAPTOR DID NOT WORK/NO POWER GENERATED. CHANGED TO ANOTHER HP2 ADAPTER TO COMPLETE CASE. NO PATIENT EFFECTS OR DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040868 ↗
• MalfunctionMay 5, 2025Break; Break

  THE HOSPITAL REPORTED THAT AFTER PROCEDURE. HEMOPRO2 ADAPTOR CORD RIPPED. THEY WENT TO REMOVE EVH HP2 EXTENSION CORD FROM THE ADAPTOR CORD AND HAD SOME DIFFICULTY. WHEN FINALLY GOT IT, THE END OF THE ADAPTOR CORD RIPPED AS WELL. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961739 ↗
• MalfunctionMar 21, 2025Failure to Deliver Energy; Failure to Deliver Energy

  RELATED TO: (B)(4). THE HOSPITAL REPORTED THAT DURING TROUBLESHOOTING OF LACK OF ENERGY DELIVERY, HEMOPRO2 ADAPTOR, WAS THOUGHT TO NOT WORK AND A REPLACEMENT WAS USED WITHOUT RESOLUTION. THE ORIGINAL VH-4020 WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENCE. THERE WAS A DELAY. NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665578 ↗
• MalfunctionFeb 24, 2025Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 ADAPTOR, IT WAS NOTED THERE WAS NO AUDIBLE TONE WHEN ATTEMPTING TO CUT/SEAL VIA BISECTOR ACTIVATION, IN ADDITION TO AN ABSENCE OF HEAT DELIVERY DESPITE ATTEMPTS TO ACTIVATE THE HARVESTER. THE MECHANISM WAS NOT DELIVERING ENERGY; THUS, THE TEAM ENACTED THESE TROUBLESHOOTING STEPS: THE POWER CORD (VH-4030) WAS FIRST REPLACED, AND AN ATTEMPT WAS MADE WITH THE SAME POWER SUPPLY, ADAPTER, AND HARVESTER (ISSUE REMAINED). THEN, A NEW POWER SUPPLY (VH-3010) ALONG WITH THE SECOND POWER CORD WAS USED WITH THE ORIGINAL ADAPTER AND EVH KIT (ISSUE REMAINED). NEXT, A THIRD POWER CORD WAS PAIRED WITH THE SECOND POWER SUPPLY, SAME ADAPTER AND EVH KIT (ISSUE REMAINED). LASTLY, THE TEAM TRIED A THIRD POWER SUPPLY, THE THIRD POWER CORD, A NEW EVH KIT, AND A NEW ADAPTER (VH-4020, FIRST TIME THE ADAPTER WAS CHANGED OUT, AND IT SOLVED THE PROBLEM). THERE WAS NO PATIENT HARM. SLIGHT PROCEDURAL DELAY, APPROXIMATELY 5-10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445661 ↗
• MalfunctionJan 13, 2025Intermittent Continuity; Loose or Intermittent Connection; Intermittent Continuity; Loose or Intermittent Connection

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, HEMOPRO2 ADAPTOR WAS INTERMITTENTLY WORKING. SINCE THERE HAD ALREADY BEEN A CASE WHERE THE ADAPTER WAS THE CULPRIT, THE CIRCULATOR TRIED TO HOLD THE EXTENSION CABLE INTO THE ADAPTER AND THE DEVICE WORKED WITHOUT ISSUES. THE CASE WAS COMPLETED WITH THE CIRCULATOR HOLDING THE ADAPTER/EXTENSION CABLE IN PLACE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138593 ↗
• MalfunctionJan 13, 2025Intermittent Continuity; Loose or Intermittent Connection; Intermittent Continuity; Loose or Intermittent Connection

  THE HOSPITAL REPORTED WHILE HARVESTING RADIAL ARTERY, THE HEMOPRO2 ADAPTOR (VH-4020) ONLY WORKED INTERMITTENTLY, AND THE EXTENSION CABLE WAS SWITCHED OUT. THIS DID NOT CHANGE THE SITUATION AND THE TEAM REALIZED THAT IT WAS THE ADAPTER. WHEN THE EXTENSION CABLE AND THE ADAPTER WERE HELD TOGETHER, IT WOULD WORK, AND SO THE CASE WAS COMPLETED WITH THE CIRCULATOR HOLDING THE TWO TOGETHER UNTIL THE CASE WAS COMPLETE. NO PT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138159 ↗
• MalfunctionDec 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, HEMOPRO2 ADAPTOR MALFUNCTIONED. THEY DETERMINED THE CAUSE TO BE THE VH-4020 AND ONCE THEY SWITCHED THE ADAPTER CABLE, IT WORKED WITHOUT ANY ISSUE. THERE WAS NO DELAY TO THE CASE OTHER THAN DETERMINING THE CAUSE AND REPLACING THE VH-4020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025999 ↗
• MalfunctionNov 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT THE HEMOPRO2 ADAPTOR IS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 20778940 ↗
• MalfunctionOct 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL REPORTED ISSUE WITH HEMOPRO2 ADAPTOR.

  Patient problems: Insufficient Information

  MAUDE report 20568164 ↗
• MalfunctionOct 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL REPORTED ISSUE WITH HEMOPRO2 ADAPTOR.

  Patient problems: Insufficient Information

  MAUDE report 20567999 ↗
• MalfunctionSep 27, 2024Connection Problem; Connection Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320669 ↗
• MalfunctionAug 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, HEMOPRO2 ADAPTOR SEEMED TO NOT TRANSMIT ENERGY TO THE JAWS WHEN ATTEMPTING TO SEAL FIRST BRANCH. ALTHOUGH THE POWER SUPPLY WAS PLUGGED IN AND THE POWER INDICATOR LIGHT WAS GLOWING, THERE WAS NO BEEPING AND NO INDICATION OF BURNING/SEALING BY THE JAWS. THE EXTENSION CABLE WAS PLUGGED INTO BOTH THE ADAPTOR AND THE HPII TECHNOLOGY. THE POWER SUPPLY WAS TURNED OFF AND ON, AND THE CABLES DETACHED AND RE-ATTACHED WITH NO CHANGE. RIGHT BEFORE THE POWER SUPPLY AND ADAPTOR WERE TO BE CHANGED OUT, THE DEVICE SUDDENLY STARTED WORKING. AFTER A FEW BURNS, IT DID NOT WORK AGAIN. THE ADAPTOR AND POWER SUPPLY WERE CHANGED OUT AT THAT POINT. AFTER THE PROCEDURE, HARVESTERS ATTEMPTED TO RECREATE THE PROBLEM TO ISOLATE THE ISSUE, BUT THE DEVICE WORKED CONTINUOUSLY WITH THE ORIGINAL POWER SUPPLY AND ADAPTOR COMBINATION. HARVESTER SUSPECTS THE ADAPTOR WAS TO BLAME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995891 ↗
• MalfunctionAug 14, 2024Failure to Deliver Energy; Failure to Deliver Energy

  THE HOSPITAL REPORTED THAT HEMOPRO2 ADAPTOR WAS NOT WORKING. AFTER DISCUSSIONS WITH THE CUSTOMER, IT WAS AGREED THE ISSUE WAS CAUSED BY USER ERROR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101274. One submission often covers many models, so check the product and lot details in each record.

• Z-2741-2026 · Jun 2, 2026 · Open, Classified
  The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under
• Z-1622-2025 · Mar 20, 2025 · Open, Classified
  The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which
• Z-1577-2025 · Mar 10, 2025 · Open, Classified
  Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
• Z-0712-2025 · Dec 9, 2024 · Open, Classified
  Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvestin
• Z-0711-2025 · Dec 9, 2024 · Open, Classified
  VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
• Z-2338-2024 · May 31, 2024 · Open, Classified
  The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which
• Z-2175-2024 · May 17, 2024 · Open, Classified
  The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model N
• Z-1336-2023 · Mar 6, 2023 · Open, Classified
  VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
• Z-0995-2023 · Dec 22, 2022 · Open, Classified
  Hemopro 2 with Vasoshield, Model VH-4001
• Z-0466-2014 · Oct 30, 2013 · Terminated
  Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing acce