Hemopro 2 w/Vasoshield VH-4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00607567700451), received between Jul 29, 2020 and Mar 11, 2026 — classified as 9 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (25 reports).

4 FDA recall records name this device's identifier, 4 still open.

6 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.

Recalls naming this device

1. Mar 20, 2025Class IIOpen, Classified

   There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.

   Z-1622-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 9, 2024Class IOpen, Classified

   Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

   Z-0712-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. May 31, 2024Class IIOpen, Classified

   There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.

   Z-2338-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 17, 2024Class IIOpen, Classified

   Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.

   Z-2175-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Infusion or Flow Problem

  THE HOSPITAL REPORTED THAT DURING HARVESTING OF THE SAPHENOUS VEIN THERE WAS USED THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD). AFTER BRANCH DISSECTION WAS COMPLETED, BRANCH LIGATION WAS ATTEMPTED. HOWEVER, WHEN THE CO2 LINE WAS ATTACHED TO THE DISTAL INSUFFLATION SITE, THE CO2 MACHINE READ "OCCLUDED". THE LINE WAS REMOVED AND REATTACHED AND THE SAME ISSUE OCCURRED. DUE TO THIS DEFECT, THE DEVICE WAS REMOVED FROM THE SURGICAL FIELD AND NEW KIT WAS OPENED. THE NEW DEVICE WAS ATTACHED TO THE CO2 LINE AND THERE WAS NO ISSUE WITH THE FLOW OF CO2. THE REMAINDER OF THE CASE WAS FINISHED WITH NO OTHER COMPLICATIONS. NO INJURIES OCCURRED DUE TO THE DEFECT. THE ONLY SURGICAL DELAY WAS THE TIME NEED TO OPEN A NEW KIT WHICH WAS LESS THAN 3 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566159 ↗
• InjuryDec 29, 2025Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT THE HARVESTER WAS USING THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) TO HARVEST THE SAPHENOUS VEIN. AFTER THE DISSECTION PROCESS WAS COMPLETED, THE HARVESTER STARTED TO PERFORM BRANCH LIGATION USING THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD). AFTER CUTTING ALMOST ALL OF THE BRANCHES, THE HARVESTER ATTEMPTED TO CUT A LARGER BRANCH BEFORE GETTING READY TO REMOVE THE VEIN FROM THE LEG. AFTER USING TECHNIQUES TO SEAL THE LARGER BRANCH, THE HARVESTER MADE SEVERAL ATTEMPTS TO CUT THE BRANCH. HOWEVER, AFTER SEVERAL ATTEMPTS, THE DEVICE WOULD NOT CUT THROUGH THE BRANCH EVEN THOUGH THE DEVICE WOULD ACTIVATE AND SEEMED LIKE ENERGY WAS BEING APPLIED TO THE BRANCH. THEREFORE, THE HARVESTER MADE A SMALL INCISION OVER THE BRANCH, PLACED SURGICAL CLIPS, AND CUT THE LARGER BRANCH WITH A SCISSORS. NO INJURY OCCURRED DUE TO THE DEFECT. THERE WAS ONLY A VERY SMALL AMOUNT OF BLEEDING DUE TO THIS (LESS THAN 5 TO 10 ML). NO TRANSFUSION WAS NEEDED. THE ONLY SURGICAL DELAY WAS THE TIME NEEDED TO CUT THE BRANCH WHICH WAS ABOUT 3 MINUTES. THE DEFECTIVE DEVICE WAS SAVED SO IT COULD BE RETURNED FOR EVALUATION AND THE APPROPRIATE GETINGE REPRESENTATIVE WAS NOTIFIED ABOUT THE COMPLAINT. THE HARVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908429 ↗
• MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT THE C-RING FROM THE VASOVIEW HEMOPRO 2 (WITH VASOSHIELD) WAS BENT OR BROKEN. THE OPENING WITHIN THE C-RING WAS SIGNIFICANTLY WIDER THAN NORMAL. THE ENTIRE SAPHENOUS VEIN HARVEST WAS COMPLETED, AND THE HARVESTER SUBSEQUENTLY REMOVED THE HARVESTING CANNULA. NO INJURY OCCURRED AS A RESULT OF THE DEFECT, AND THE CASE WAS COMPLETED WITHOUT ANY COMPLICATIONS. NO PARTS OF THE C-RING BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874022 ↗
• MalfunctionDec 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT AT THE BEGINNING OF THE PROCEDURE THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) WAS NOT WORKING. THE EXTENSION CABLE AND PIGTAIL WERE SWITCHED, HOWEVER, THE DEVICE WAS STILL NOT WORKING. POWER SETTING ON THE HEMOPRO POWER SUPPLY WAS 3. NO BEEPING SOUND WAS HEARD WHEN THE TOGGLE WAS PULLED BACK TO ACTIVATE THE DEVICE. ANOTHER DEVICE WAS OPENED AND IT WORKED WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED. THERE WAS 10 MINUTES DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776550 ↗
• MalfunctionOct 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT VASOVIEW HEMOPRO 2 (W/VASOSHIELD) WAS NOT CAUTERIZING WELL DURING THE LIGATION PHASE OF THE PROCEDURE. PRE-CAUTERY TEST WAS PERFORMED AND THAT IS WHEN IT WAS DETERMINED THAT THE HEMOPRO 2 WAND DID NOT WORK. BEEPING SOUND WAS HEARD BUT NO STEAM WAS PRODUCED. THEY TRIED ON SOME SOFT TISSUE IN THE TUNNEL TO CONFIRM LACK OF ENERGY DELIVERY BEFORE TROUBLESHOOTING BEGAN. POWER SETTING WAS AT 3 PER THE IFU. TROUBLESHOOT DID TAKE TIME TO SWAP OUT THE CABLES AND OPEN THE 2ND VH-4001 BUT THE PROCEDURE WAS NOT DELAYED AS THE VEIN WAS PROCURED IN TIME. THEY TRIED REPLACING THE CORDS WITHOUT SUCCESS. VH-4001 WAS THEN REPLACED WITH A NEW KIT USING THE ORIGINAL CABLES WHICH SEEMS TO RESOLVE THE ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328110 ↗
• MalfunctionOct 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278395 ↗
• MalfunctionSep 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982379 ↗
• InjurySep 2, 2025No Flow; No Flow

  THE HOSPITAL REPORTED THAT DURING PROCEDURE USING VH-4001 VASOVIEW HEMOPRO 2 WITH VASOSHIELD, ¿THE CANNULA KEEPS SAYING ¿OCCLUSION.¿¿ GETINGE REP CHRIS CARSON WHO SPOKE WITH CUSTOMER, GAVE THEM SOME TESTS TO RUN. THEY MOVED ON FROM OUR DEVICE AND OPENED UP THE PATIENT'S LEG. THE NURSE WHO REPORTED THE COMPLAINT STATED, "I ASSUME PT IS DOING GOOD, BECAUSE I HAVEN'T HEARD OTHERWISE". INSUFFLATOR USED WAS STRYKER PNEUMOCLEAR C02 CONDITIONING INSUFFLATOR. DISPOSABLE TUBING WAS STRYKER PNEUMOCLEAR HIGH-FLOW TUBE SET. NO SMOKE EVACUATION WAS USED. THE SETTING THAT SELECTED WAS VESSEL HARVEST THE PRESSURE WAS 12 AND FLOW WAS 4 AND NO SETTINGS WERE CHANGED. THE TROUBLESHOOTING STEPS TAKEN WERE, 1ST ASSIST WENT TO PUT THE PORT IN THE LEG AND TRIED TO INSUFFLATE. 1ST THEY TRIED RESETTING THE INSUFFLATOR. 2ND THE 1ST ASSIST REMOVED THE BLUE SEAL FROM THE TUBE CONNECTED TO THE CANNULA. 3RD THEY OPENED A NEW DISPOSABLE INSUFFLATOR TUBING SET. 4TH THEY OPENED A NEW DISPOSABLE VESSEL HARVESTING SYSTEM ACCESSORY PACK. 5TH THE FIRST ASSIST REMOVED THE BLUE SEAL FROM THE TUBE CONNECTED TO THE CANNULA AGAIN. NONE OF THESE LISTED CORRECTED THE ISSUE. AFTER THAT THEY DECIDED TO OPEN THE LEG. TUBING WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932126 ↗
• MalfunctionJun 30, 2025Intermittent Continuity; Intermittent Continuity

  THE HOSPITAL REPORTED THEY WERE USING THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) TO HARVEST THE SAPHENOUS VEIN. AFTER THE DISSECTION PROCESS WAS COMPLETED, THE HARVESTER STARTED TO PERFORM BRANCH LIGATION. AFTER CUTTING SEVERAL BRANCHES, THE DEVICE STOPPED WORKING. EVEN THOUGHT THE DEVICE WAS NOT USED LONG AND WAS NOT ACTIVATED FOR AN EXTENDED PERIOD, THE HARVESTER ASSUMED THAT THE DEVICE HAD OVERHEATED. THEREFORE, THE HARVESTER WAITED AT LEAST 45 SECONDS BEFORE USING THE DEVICE AGAIN. HOWEVER, FROM THIS TIME ON THE DEVICE WOULD INTERMITTENTLY WORK WITH NO OBVIOUS REASON FOR THE DEVICE FAILING TO ACTIVATE. IN OTHER WORDS, THE DEVICE WOULD NOT ALWAYS ACTIVATE WHEN THE TOGGLE WAS PULLED. THE CASE WAS FINISHED USING THE SAME DEVICE WITH NO ADVERSE OUTCOMES TO THE PATIENT. DUE TO THE INTERMITTENT ACTIVATION, THERE WAS A SLIGHT SURGICAL DELAY OF ABOUT 3 TO 5 MINUTES TO COMPLETE THE HARVEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359153 ↗
• MalfunctionJun 11, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE HOSPITAL REPORTED THAT THEY WERE USING VASOVIEW HEMOPRO 2 (W/VASOSHIELD) TO BEGIN THE SAPHENOUS VEIN HARVEST BUT QUICKLY REALIZED INSUFFLATION WAS AN ISSUE. DESPITE SEVERAL TROUBLESHOOTING TECHNIQUES THE TEAM COULD NOT CREATE ANY CO2 FLOW; A THREE-WAY STOPCOCK, SEVERAL CHECKS OF THE TOWER, AND VARIOUS ATTEMPTS AT DISTAL AND PROXIMAL INSUFFLATION. ONCE A NEW KIT WAS OPENED IT SOLVED THE PROBLEM. NO COMPONENTS WERE LEFT INSIDE THE PATIENT, THERE WAS NO PATIENT HARM, AND IT RESULTED IN A MILD CASE DELAY OF APPROXIMATELY 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191172 ↗
• MalfunctionApr 25, 2025Melted; Melted

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, ONE SIDE OF THE VASOVIEW HEMOPRO 2 WITH VASOSHIELD JAWS SILICONE MELTED OFF. USER CLAIMS THAT IT HAPPENED EARLY ON IN THE CASE ABOUT 5 MINUTES INTO THE PROCEDURE WHEN THEY STARTED CUTTING/SEALING BRANCHES. POWER SUPPLY SETTING AT 3. THEY OPENED ANOTHER KIT TO FINISH THE CASE WITH NO OTHER ISSUES. THERE WAS NO PATIENT HARM. PER PHOTO PROVIDED BY THE COMPLAINANT, IT IS OBSERVED THAT THE SILICONE WAS MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914824 ↗
• MalfunctionMar 20, 2025Melted; Material Twisted/Bent; Melted; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING RADIAL ENDOSCOPIC VESSEL HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (W/VASOSHIELD), THEY CLARIFIED THAT IT WAS A DETACHED HEATING WIRE THAT OCCURRED. THEY RESUMED THE PROCEDURE WITH THE SAME DEVICE WITHOUT ANY PROBLEM OR HARM FOR THE PATIENT. POWER SOURCE SETTING AT 3. NO DELAYS OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21659486 ↗
• MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT PRIOR TO STARTING THE CASE AND USE OF THE DEVICE, WHEN THEY OPENED THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) , 1 SIDE OF THE METAL WAS SEPARATED FROM THE JAWS. THEY OPENED ANOTHER KIT AND COMPLETED THE CASE WITH NO OTHER ISSUES. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606965 ↗
• MalfunctionMar 13, 2025Electrical /Electronic Property Problem; Material Twisted/Bent; Electrical /Electronic Property Problem; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING A SAPHENOUS ENDOSCOPIC VESSEL HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (W/VASOSHIELD) (VH-4001). AFTER THE DISSECTION PROCESS WAS COMPLETED, THE HARVESTER ATTEMPTED TO PERFORM BRANCH LIGATION. HOWEVER, AFTER ATTEMPTING TO HARVEST 2 SMALL BRANCHES, THE DEVICE WOULD NO LONGER ACTIVATE WHEN THE TOGGLE WAS PULLED. IN OTHER WORDS, THE DEVICE WOULD NOT LIGATE BRANCHES. THE HARVESTER DID NOT FEEL THAT THE DEVICE WAS OVERHEATED BECAUSE IT WAS ONLY USED TO BRIEFLY LIGATE 2 SMALL BRANCHES. THEREFORE, NEW CABLES AND A NEW GENERATOR WAS USED. UNFORTUNATELY, THE DEVICE AGAIN FAILED TO ACTIVATE. THE DEVICE WAS THEN DEEMED UNSAFE FOR USE AND WAS REMOVED FROM THE SURGICAL FIELD. A NEW KIT WAS OPENED UP. THIS KIT WORKED AS EXPECTED AND THE CASE WAS FINISHED WITH NO OTHER ISSUES. NO INJURIES OCCURRED DUE TO THE DEFECT. BOTH GENERATORS USED WERE SET A 3. THE ONLY SURGICAL DELAY WAS THE TIME NEEDED TO OPEN UP A NEW KIT AND TO SWITCH OUT THE CABLES AND GENERATORS, WHICH WAS ABOUT 3 TO 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599567 ↗
• MalfunctionFeb 18, 2025Inflation Problem; Inflation Problem

  THE HOSPITAL REPORTED THAT DURING A SAPHENOUS ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE HARVESTER WAS USING THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) (VH-4001). DURING THE DISSECTION PROCESS THE HARVESTER NOTICED THAT TUNNEL BEING CREATED IN THE LEG WOULD NOT HOLD ANY CO2 PRESSURE. AN ATTEMPT WAS MADE TO ADJUST THE CO2 SETTINGS AND THERE WAS STILL NO CO2 PRESSURE BEING MAINTAINED. AFTER PULLING THE ENDOSCOPE OUT OF THE LEG, THE HARVESTER NOTICE THAT THERE WAS A TEAR IN THE RUBBER ON THE BTT PORT. THEREFORE, THE DECISION WAS MADE TO OPEN UP AN ACCESSORY KIT (VH 2004) TO GET A NEW BTT PORT. AFTER THIS WAS DONE, THE NEW BTT PORT ALLOWED FOR THE CO2 PRESSURE TO HOLD AND THE CASE WAS FINISHED WITH NO OTHER COMPLICATIONS. NO INJURIES OCCURRED DUE TO THE DEFECT. THE ONLY SURGICAL DELAY WAS THE TIME NEEDED TO OPEN AN ACCESSORY KIT WHICH WAS ABOUT 3 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407165 ↗
• MalfunctionFeb 13, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING A SAPHENOUS ENDOSCOPIC VESSEL HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (W/VASOSHIELD) (VH 4001), AFTER COMPLETING THE DISSECTION PROCESS, THE HARVESTER STARTED TO USE THE HEMOPRO 2 DEVICE TO PERFORM BRANCH LIGATION. HOWEVER, AFTER LIGATING SEVERAL BRANCHES THE HARVESTER NOTICED THAT THE METAL IN THE JAWS OF THE HARVESTING TOOL HAD PULLED AWAY FROM THE OUTER COATING OF THE JAWS. THIS CREATED A "FORK-LIKE" APPEARANCE. DUE TO THIS DEFECT, THE DEVICE WAS DEEMED UNSAFE FOR USE AND WAS IMMEDIATELY REMOVED FROM THE SURGICAL FIELD. A NEW HEMOPRO 2 KIT WAS OPENED UP AND THE REMAINDER OF THE CASE WAS FINISHED WITH NO OTHER COMPLICATIONS. THE ONLY PROCEDURAL DELAY WAS THE TIME NEEDED TO OPEN A NEW HEMOPRO 2 KIT WHICH WAS ABOUT 3 TO 5 MINUTES. NO INJURIES OCCURRED DUE TO THE DEFECT AND THE GENERATOR WAS CORRECTLY SET AT A SETTING OF 3. PER THE PHOTO, IT SHOWS THAT THE METAL IN THE JAWS OF THE DEVICE HAD PULLED AWAY FROM THE OUTER COATING OF THE JAWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378919 ↗
• InjuryJan 24, 2025No Flow; No Flow

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (W/VASOSHIELD) , MORE THAN HALFWAY THROUGH HARVESTING RADIAL ARTERY ENDOSCOPICALLY, THE USER LOST THEIR TUNNEL. THE CO2 WAS AT THE BTT PORT AT THIS TIME. THEY SWITCHED INSUFFLATION TO DISTAL AND STILL COULD NOT GET A TUNNEL. PATIENT WAS VERY MUSCULAR AND THEY BELIEVED THAT MAY HAVE BEEN THE PROBLEM. THEY CONSIDERED SWITCHING OUT THE TUBING BUT THEY DID NOT DO THAT. SINCE THEY COULD NOT VISUALIZE THE LAST FEW CENTIMETERS OF THE RADIAL ARTERY ENDOSCOPICALLY, THEY ENDED UP OPENING THE ARM TO GET THE LAST SEGMENT. THERE WAS A DELAY. PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229832 ↗
• MalfunctionJan 6, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PREPARATION, C-RING ARMS WERE BENT UPON OPENING THE PACKAGING OF VH-4001 (IMAGE INCLUDED). NO PATIENT IN THE ROOM. ANOTHER VH-4001 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO DELAY TO THE PROCEDURE. A PHOTO WAS PROVIDED BY THE COMPLAINANT. THE C-RING IS OBSERVED TO BE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079826 ↗
• MalfunctionNov 26, 2024Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT AT THE BEGINNING OF THE CASE THE USER NOTICED THAT ONE SIDE OF THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) JAWS HAD SEPARATED. THE DEVICE WAS HANDED TO HER ALREADY PUT TOGETHER SO SHE WAS NOT SURE WHETHER IT WAS LOADED PROPERLY OR NOT. THEY OPENED ANOTHER TO FINISH THE CASE WITH NO ISSUES. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778495 ↗
• MalfunctionNov 25, 2024Intermittent Continuity; Intermittent Continuity

  THE HOSPITAL REPORTED THAT THEY WERE USING THE VASOVIEW HEMOPRO 2 (W/VASOSHIELD) TO HARVEST THE SAPHENOUS VEIN. AFTER THE DISSECTION PROCESS WAS COMPLETED, THEY STARTED TO PERFORM BRANCH DISSECTION. AFTER CUTTING SEVERAL BRANCHES THEY NOTICED THAT THE DEVICE STOPPED WORKING. THEY ASSUMED THAT THE SAFETY MECHANISM FOR OVERHEATING WAS ACTIVATED AND DECIDED TO GIVE THE DEVICE THE APPROPRIATE TIME TO COOL DOWN. AFTER WAITING FOR ABOUT A MINUTE, THE DEVICE WAS ATTEMPTED TO BE USED AGAIN BUT DID NOT ACTIVATE WHEN TRYING TO CUT A BRANCH. THE CORDS AND GENERATOR WERE CHECKED AND NO ISSUES WERE FOUND WITH THIS. THE GENERATOR WAS SET AT 3. DUE TO THIS ISSUE, THE DEVICE WAS DEEMED UNSAFE FOR USE AND WAS REMOVED FROM THE SURGICAL FIELD. A NEW KIT WAS OPENED AND THE REMAINDER OF THE CASE WAS FINISHED WITHOUT ANY FURTHER COMPLICATIONS. NO INJURIES OCCURRED DUE TO THE DEFECT. THE ONLY SURGICAL DELAY WAS THE TIME NEEDED TO OPEN UP A NEW KIT, WHICH WAS ABOUT 3 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774832 ↗
• MalfunctionNov 14, 2024Intermittent Continuity; Intermittent Continuity

  THE HOSPITAL REPORTED THAT DURING SAPHENOUS ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 (W/VASOSHIELD) WOULD STOP WORKING IN THE MIDDLE OF THE LIGATION PROCESS. THERE WAS NO OBVIOUS REASON FOR THE OVERHEATING SAFETY MECHANISM TO BE ACTIVATED. THE GENERATOR AND ALL POWER CORDS WERE REPLACED. UNFORTUNATELY, THE SAME PROBLEM CONTINUED. THE POWER WAS SET TO 3. THEREFORE, THE DEVICE WAS DEEMED UNSAFE FOR USE AND WAS REMOVED FROM THE SURGICAL FIELD. A NEW DEVICE WAS OPENED AND THE REMAINDER OF THE CASE WAS FINISHED WITH NO OTHER ISSUES. THE ONLY SURGICAL DELAY WAS THE TIME NEEDED TO OPEN UP A NEW KIT WHICH WAS ABOUT 3 MINUTES. NO INJURIES OCCURRED DUE TO THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688985 ↗
• MalfunctionNov 6, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE OF THE SAPHENOUS VEIN, VASOVIEW HEMOPRO 2 (W/VASOSHIELD) HAD A HAIR INSIDE THE STERILE PLASTIC CONTAINER BEFORE THE KIT WAS OPENED. IT WAS DEEMED UNSTERILE AND UNSAFE TO USE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER COMPLICATIONS. THERE WAS A DELAY OF 2-3 MINUTES TO OPEN THE NEW DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616784 ↗
• MalfunctionOct 2, 2024Intermittent Continuity; Intermittent Continuity

  RELATED TO (B)(4) THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 (W/VASOSHIELD) EXPERIENCED INTERMITTENT CUT AND SEAL. THEY SWITCHED OUT THE PIGTAIL AND EXTENSION AND WAS GETTING THE SAME RESULT. THEY OPENED ANOTHER KIT AND WERE ABLE TO COMPLETE THE CASE. DELAY FOR THE TIME IT TOOK TO SWITCH OUT THE CORDS. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352859 ↗
• InjuryOct 2, 2024Failure to Cut; Failure to Cut

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352589 ↗
• MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 (W/VASOSHIELD) WAS SEPARATED OF THE METAL PIECE FROM THE JAWS. THEY SAID IT WAS PROBABLY USER ERROR BECAUSE WHEN THEY WERE HANDED THE DEVICE, IT WAS ALREADY PUT TOGETHER BY A NEW TECH THAT WAS THERE WHO DIDN'T KNOW THAT YOU HAD TO HAVE THE JAWS UP DURING INSERTION AND PREFERABLY THE SCOPE IN THE HARVESTING CANNULA AS WELL. THEY OPENED ANOTHER KIT TO COMPLETE THE CASE WITH NO OTHER ISSUES. 2-3 MINUTE DELAY TO OPEN UP ANOTHER KIT AND PROCEED WITH CASE. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334355 ↗

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-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-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-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