Vasoview Hemopro VH-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00607567700345), received between Jan 26, 2018 and Jun 28, 2024 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

3 FDA recall records name this device's identifier, 3 still open.

4 other recalls cover devices cleared under the same FDA submission (K052274); 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. 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-2337-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2176-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 6, 2023Class IIOpen, Classified

   Some batches of product were not sterilized to their minimum sterilization specification.

   Z-1337-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Mechanical Problem; Fitting Problem; Mechanical Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 BISECTOR WAS NOT COMING OUT OF THE DEVICE IN THE USUAL FASHION AND PART OF THE DEVICE WHICH IS SUPPOSED TO RETRACT BACK INTO THE DEVICE ALL THE WAY WAS NOT DOING SO.

  Patient problems: Insufficient Information

  MAUDE report 19633464 ↗
• MalfunctionApr 5, 2023Self-Activation or Keying; Self-Activation or Keying

  THE HOSPITAL REPORTED THAT WHEN THEY OPENED THE VASOVIEW HEMPORO (OUS) VH-3000 PACKAGE, THE PRODUCT TO THE POWER, AND THE TIP OF THE SCISSORS BURNED ITSELF WITHOUT TOUCHING THE SWITCH ON. THE DOCTOR CONSIDER IF IT WAS AN ELECTRICAL SHORT CIRCUIT, AND THEY CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686191 ↗
• MalfunctionFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HOSPITAL WANTED TO SHARE SOME INSIGHT ABOUT A LESS FREQUENT COMPLICATION OF EVH, VASOVIEW HEMOPRO VH-3000 WHICH IS CO2 EMBOLISMS. THEY HAVE SEEN THESE A COUPLE OF TIMES, AND WERE ABLE TO CATCH IT IMMEDIATELY AND FIX IT WITHOUT HAVING TO COMPLETELY STOP HARVESTING. THEY FOUND THAT IF YOU KEEP THE CVP LOWER THAN THE GAS PRESSURE, YOU SHOULD NOT RUN INTO THIS ISSUE. THERE WAS NO PATIENT ADVERSE PATIENT EFFECTS.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13527267 ↗
• MalfunctionSep 16, 2021Self-Activation or Keying; Self-Activation or Keying

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484716 ↗
• InjuryDec 3, 2020Peeled/Delaminated; Peeled/Delaminated

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO (US) VH-3000, THE DARKER GREY PLASTIC JAW THAT SEPARATED AT THE HINGE POINT FELL IN THE PATIENT AND THEY HAD TO RETRIEVE IT FROM THE LEG. THEY WERE ABLE TO RETRIEVE IT ENDOSCOPICALLY. NO DAMAGE DONE TO PATIENT OR VEIN, ALL PARTS ACCOUNTED FOR AND REPLACEMENT HEMOPRO OPENED TO FIELD.

  Patient problems: Burn(s); No Consequences Or Impact To Patient

  MAUDE report 10937897 ↗
• MalfunctionNov 19, 2020No Flow; No Flow

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO VH-3000, THE CO2 WOULD NOT FLOW INTO THE TUNNEL. THEY WERE ABLE TO GET PRESSURE BUT COULD NOT GET FLOW WHEN THE GAS WAS CONNECTED TO THE PORT. THEY OPENED UP A 3 WAY STOP COCK AND STILL COULD NOT GET FLOW. THE SETTING ON THE INSUFFLATOR WERE AT 12 MM/HG AND 5 L/MIN AND THEY WERE GETTING ADEQUATE CO2 OUT OF THE TUBING WHEN PUTTING UP TO THEIR FACES, BUT ONCE CONNECTED TO THE BTT PORT THE FLOW WOULD NOT FLOW INTO THE LEG. AT THAT POINT THEY OPENED A NEW DEVICE AND WERE ABLE TO GET FLOW AND FINISH THE HARVEST. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10869167 ↗
• MalfunctionOct 14, 2020Peeled/Delaminated; Peeled/Delaminated

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMPRO (US) VH-3000, JAWS WERE SHEARED WHEN OUT OF THE PACKAGE A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678102 ↗
• MalfunctionSep 30, 2020Particulates; Contamination /Decontamination Problem; Particulates; Contamination /Decontamination Problem

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO (US) VH-3000. IT WAS NOTICED THAT THERE WAS A HAIR UNDER THE "GASKET" IN THE ACCESSORY TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 10610919 ↗
• MalfunctionAug 14, 2020Self-Activation or Keying; Self-Activation or Keying

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO (US) VH-3000, SMOKE COMING FROM JAWS OF INSTRUMENT AFTER DEVICE WAS TAKEN OUT OF THE LEG AND ENERGY WASN'T BEING ACTIVATED BY THE HARVESTER. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10406737 ↗
• MalfunctionJul 30, 2020Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO (US) VH-3000, CUSTOMER MENTIONED A GENERAL ISSUE WITH DIFFICULTY ADVANCING THE CUTTING TOOL WITHIN THE HARVESTING CANNULA. SPECIFICALLY THEY MENTIONED THAT IT IS OFTEN TIMES VERY DIFFICULT TO ADVANCE IT DURING A VESSEL HARVEST AND THEY HAD ISSUES WITH SMALL BRANCH EVULSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347265 ↗
• MalfunctionMar 10, 2020Defective Device

  DURING VEIN HARVESTING FOR OPEN HEART SURGERY, THE SCRUB STATED IT STOPPED WORKING AND WHEN IT WAS PULLED OUT BY THE PHYSICIAN'S ASSISTANT, IT LOOKED DEFECTIVE. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, VASOVIEW HEMOPRO (PER SITE REPORTER) THEY HAVE ACKNOWLEDGED RECEIPT OF THE DEVICE AND ASSIGNED COMPLAINT REFERENCE #.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9810762 ↗
• MalfunctionDec 20, 2019Break

  AN ELDERLY MALE PATIENT WITH HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HYPERTENSION (HTN), AND PERIPHERAL VASCULAR DISEASE (PVD) PRESENTS WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). HE WENT TO OPERATING ROOM FOR CORONARY ARTERY BYPASS GRAFTING (CABG) X 3, MAZE AND ATRIAL APPENDAGE CLIP. DURING THE HARVEST OF VESSEL IN THE RIGHT LEG, "A PART OF THE RUBBER TIP OF THE HEMOPRO BROKE OFF WHILE INSIDE OF THE PATIENT'S RIGHT LEG. CAREGIVER WAS ABLE TO REMOVE THE BROKEN PIECE INTACT FROM THE PATIENT'S LEG WITHOUT AN EXTRA INCISION."

  Patient problems: Foreign Body In Patient

  MAUDE report 9505190 ↗
• MalfunctionDec 20, 2019Break; Material Separation

  AN ELDERLY MALE PATIENT WITH HISTORY OF TYPE TWO DIABETES MELLITUS (DM2) AND HYPERTENSION AND PRESENTED WITH NON- ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). WHILE HAVING A " CORONARY ARTERY BYPASS GRAFTING X4 WITH LEFT INTERNAL MAMMARY ARTERY TO LEFT ANTERIOR DESCENDING CORONARY ARTERY, REVERSE SAPHENOUS VEIN SEGMENTS TO FIRST DIAGONAL, SECOND OBTUSE MARGINAL AND RIGHT CORONARY ARTERIES ENDOSCOPIC VEIN HARVESTING, GREATER SAPHENOUS VEIN, LEFT LEG., "VASOVIEW HEMOPRO CAUTERY TIP BROKEN WHILE IN USE" TIP CAME APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503375 ↗
• MalfunctionOct 9, 2019Break; Detachment of Device or Device Component

  AN ELDERLY MALE PATIENT WITH 2 WEEK HISTORY OF CHEST PAIN WAS SCHEDULED TO UNDERGO A CORONARY ARTERY BYPASS GRAFT. WHILE HARVESTING THE GREATER SAPHENOUS VEIN, THE PLASTIC PART OF THE BOVIE TIP OF THE VASOVIEW HEMOPRO BROKE OFF INSIDE THE PATIENT'S RIGHT LEG. A NEW VASOVIEW HEMOPRO KIT WAS OPENED AND USED TO SUCCESSFULLY RETRIEVE THE PLASTIC PARTS INSIDE THE PATIENT'S LEG. PLEASE REFER TO TWO PREVIOUS REPORTED INCIDENTS WITH BROKEN AND CRACKED TIP- SAME PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9172728 ↗
• MalfunctionOct 2, 2019Break; Detachment of Device or Device Component

  DURING LEG VEIN HARVESTING FOR OPEN HEART SURGERY, THE WHITE INSULATION AT THE TIP OF THE ENDO VEIN HARVEST BROKE OFF. THE PHYSICIAN'S ASSISTANT AND SCRUB ON THE FIELD TOOK THE BROKEN TIP, INSPECTED IT AND PASSED IT OFF TO THE RN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144717 ↗
• MalfunctionSep 30, 2019Break; Detachment of Device or Device Component

  THE RUBBER TIP OF THE VASOVIEW HEMOPRO BROKE OFF INSIDE OF THE PATIENT'S RIGHT LEG. TIP WAS RETRIEVED FROM PATIENT. PACKAGING AND EQUIPMENT SAVED. PRODUCT AND PACKAGING OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9134511 ↗
• MalfunctionSep 19, 2019Therapeutic or Diagnostic Output Failure

  PHYSICIAN'S ASSISTANT (PA) WAS USING THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM WHILE CONDUCTING AN ENDOSCOPIC VEIN HARVEST, AND WHEN THE PROVIDER ATTEMPTED TO USE THIS DEVICE TO CAUTERIZE A VEIN, THE UNIT HAD NO CONDUCTION, WHICH MEANS THE PHYSICIAN'S ASSISTANT WAS UNABLE TO CLOSE UP THE VEIN. OPERATING ROOM TEAM HAD TO OPEN A NEW UNIT, WHICH WORKED AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086151 ↗
• MalfunctionAug 30, 2019Crack; Device Fell

  PATIENT WAS UNDERGOING CORONARY ARTERY BYPASS GRAFT X2 (LEFT INTERNAL MAMMARY TO THE LEFT ANTERIOR DESCENDING, SAPHENOUS VEIN GRAFT TO THE MAIN OBTUSE MARGINAL. DURING THE HARVEST OF THE SAPHENOUS VEIN, THE TIP OF THE SCOPE WITH THE PLASTIC SHEATH CRACKED AND FELL OFF IN THE LEG. THE DEVICE WAS CHANGED AND THE PROCEDURE CONTINUED AND COMPLETED WITH NO PATIENT HARM DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8949830 ↗
• MalfunctionAug 16, 2019Self-Activation or Keying

  AN ELDERLY MALE PATIENT RECEIVED A BURN FROM THE HARVESTING TOOL/FORCEPS WHEN IT WAS TURNED OFF AND NOT ACTIVATED WHILE PERFORMING THE HARVEST AND TUNNELING THE LEFT LEG, SAPHENOUS VEIN. THIS CAUSED A TRANSECTION OF THE VEIN. SEGMENTS OF THE SAPHENOUS VEIN WERE ABLE TO BE USED AS BYPASS GRAFTS. THE LEFT LEG INCISION IS HEALING WELL AND WITHOUT SIGNS OF INFECTION.

  Patient problems: Burn(s)

  MAUDE report 8900851 ↗
• MalfunctionJul 18, 2019Break; Appropriate Device Problem Term/Code Not Available

  THE INSULATION FELL APART ON VASOVIEW HEMOPRO DEVICE. THE DEVICE WAS REMOVED FROM SERVICE AND REPLACED WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802154 ↗
• MalfunctionMay 22, 2019Smoking; Failure to Shut Off; Temperature Problem; Physical Resistance/Sticking

  MALE PATIENT IN OPERATING ROOM FOR CABG. DURING THE ENDOSCOPIC VEIN HARVEST, THE VASOVIEW HEMOPRO ELECTROCAUTERY DEVICE BECAME STUCK IN THE "ON" POSITION, CAUSING THE ELECTRODES TO BECOME "RED-HOT" AND SMOKE TO BE SEEN WHEN THE DEVICE HAD NOT BEEN ACTIVATED. THE DEVICE WAS QUICKLY DISCONNECTED FROM THE GENERATOR TO STOP THE ENERGY DELIVERY. TEAM OBTAINED A NEW DEVICE AND CONTINUED THE PROCEDURE. UNABLE TO OBSERVE ANY OBVIOUS PATIENT DAMAGE OR INJURY. PER THE TEAM, ONE THING THAT COULD HAVE BEEN DONE TO PREVENT THIS FROM GETTING TO THE PATIENT IS A BENCH TEST BY THE SCRUB, WHICH WAS NOT DONE. THE BENCH TEST INVOLVES EITHER DUNKING THE TIP IN SALINE, OR GRASPING A SALINE MOISTENED SPONGE AND TEST FIRING THE DEVICE, OBSERVING STEAM RISE AND STOPPED WHEN BUTTON IS RELEASED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631062 ↗
• MalfunctionMay 2, 2019Break

  ELECTIVE CAB. PA WAS PERFORMING ENDOSCOPIC VEIN HARVESTING USING VASOVIEW HEMOPRO #VH-3000, MAQUET LOT #25144498, EXP DATE: 2020-02-07, ENDOSCOPIC VESSEL HARVESTING SYSTEM. DURING PROCESS, SCISSOR TIP CRACKED/BROKE. IT WAS REMOVED FROM SERVICE AND SENT TO RM. A NEW SYSTEM WAS OPENED. VASOVIEW HEMOPRO # VH -3000, MAQUET LOT #2514464,9 EXP DATE 2020-02-13 - AGAIN DURING HARVEST, THE SCISSOR TIP BROKE - TIP SAVED AND TAPED TO THE INSTRUMENT. REMOVED FROM SERVICE AND SENT TO RM. PT STABLE - NO INJURIES NOTED. PT TO ICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8572995 ↗
• MalfunctionApr 11, 2019Component Missing

  DURING ENDOSCOPIC VEIN HARVESTING, PROVIDER NOTICED THAT A SMALL SECTION OF INSULATION WAS MISSING AND ALLOWED A POTENTIAL TO SHOCK THE STAFF.

  Patient problems: Electric Shock

  MAUDE report 8503442 ↗
• MalfunctionApr 11, 2019Smoking

  THE PHYSICIAN ASSISTANT WAS USING THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM BY MAQUET, REF# (B)(4), TO ACQUIRE A LENGTH OF VEIN FOR BYPASS SURGERY. WHILE USING THE CAUTERY OF THE SCISSOR TIP, SMOKE APPEARED. WHILE THE JAWS OF THE SCISSOR WERE OPEN, THE CAUTERY ACTIVATED. THE SCISSOR (CAUTERY DEVICE) WAS REMOVED FROM USE AND A NEW ONE WAS OPENED. HANDWRITTEN ON THE DEVICE BOX AFTER THE INCIDENT: "CAUTERY ACTIVATING WHILE TIPS OPEN AND TIPS EXPELLING SMOKE." MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, VASOVIEW HEMOPRO (PER SITE REPORTER). THE MAQUET REP. IS FORWARDING THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503141 ↗
• MalfunctionNov 19, 2018Break; Defective Device; Detachment of Device or Device Component

  A MAQUET VASOVIEW HEMOPRO WAS USED FOR VEIN HARVEST FROM THE PATIENT'S RIGHT LEG. THE PHYSICIAN ASSISTANT SAW THE RUBBER TIP OF THE HEMOPRO BROKE OFF ON THE CAMERA/MONITOR, PULLED IT OUT FROM THE PATIENT'S LEG AND THE PIECE THAT BROKE OFF WAS RETRIEVED. THERE WAS NO PATIENT HARM. THE PIECE THAT BROKE OFF FROM THE TIP OF THE HEMOPRO WAS SENT TO MAQUET TOGETHER WITH THE DEVICE. PLEASE ALSO NOTE THIS IS THE THIRD REPORT SINCE JUNE 2018 THAT WE HAVE SUBMITTED. RE: DEFECTIVE HEMOPRO DEVICES. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, VASOVIEW HEMOPRO (PER SITE REPORTER). WE RECEIVED AN ACKNOWLEDGEMENT LETTER FROM GETINGE THAT THEY HAVE OPENED COMPLAINT TO DOCUMENT THEIR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052274. One submission often covers many models, so check the product and lot details in each record.

• Z-0092-2025 · Sep 20, 2024 · Open, Classified
  VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
• Z-0723-2024 · Dec 1, 2023 · Open, Classified
  Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
• 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
• Z-3272-2011 · Dec 17, 2009 · Terminated
  VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvest