Virtuosaph Plus with Radial Indication VSP550EXRecalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 00699753450769), received between Jun 1, 2018 and Jul 31, 2026 — classified as 107 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Break

  The user facility reported to Terumo Cardiovascular that during vein harvesting procedure, the harvester tip broke off in the patient's leg. The issue caused a delay in the procedure, and it damaged the vein.Product was changed out.Procedure completed successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50107753 ↗
• MalfunctionJul 28, 2026Gas/Air Leak; Pressure Problem

  CO2 gas leak/ would not maintain pressure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053490 ↗
• MalfunctionMay 28, 2026

  BIPOLAR WOULD NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315956 ↗
• InjuryFeb 13, 2026Break

  A MEDSUN UF/IMPORTER REPORT WAS SENT TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, THE PART OF THE PLASTIC TIP OF THE BI-POLAR FORCEP BROKE OFF OF THE VEIN HARVESTER. *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 2-3 MINUTES OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338247 ↗
• InjuryFeb 2, 2026Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, DURING VEIN HARVESTING PROCEDURE, WHILE HARVESTING THE SAPHENOUS VEIN, THE PLASTIC PIECE ON THE TIP OF THE TERUMO VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM BROKE OFF. PIECE WAS RETRIEVED AND NO EVIDENT HARM WAS CAUSED TO THE PATIENT. EQUIPMENT WAS EXCHANGED. THE ONLY DELAY WAS WAITING FOR A NEW ONE TO BE OPENED. *PRODUCT WAS CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240720 ↗
• MalfunctionJan 29, 2026Sparking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, ELECTRIC LEAKAGE OCCURRED AT THE END OF THE V-CUTTER WITH SPARKS EMITTED. THE BRAND OF GENERATOR WAS VALLEYLAB. THE GENERATOR SETTINGS WERE 20 AND THEY WERE NOT MODIFIED DURING THE CASE. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211102 ↗
• MalfunctionJan 7, 2026

  IN CVOR - PART OF THE PLASTIC TIP OF THE BI-POLAR FORCEP BROKE OFF OF THE VEIN HARVESTER. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990425 ↗
• InjuryDec 23, 2025Failure to Conduct; Failure to Conduct

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING THE VEIN HARVESTING PROCEDURE, THE V-CUTTER DIDN'T WORK. THE GENERATOR USED WAS A COVIDIEN FORCE FX WITH SETTINGS CONFIGURED TO MACRO AND BIPOLAR: 9¿10. THE V-CUTTER WAS ATTEMPTED TO BE REPOSITIONED TO IMPROVE GROUNDING, THE ISSUE PERSISTED. THIS RESULTED IN THE PROCEDURE BEING CHANGED TO OPEN VEIN HARVEST. THERE WAS A 2-HOUR DELAY IN THE CONTINUING OF THE PROCEDURE. PROCEDURE COMPLETED SUCCESSFULLY. UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877636 ↗
• InjuryDec 23, 2025Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, THE TIP BROKE OFF INSIDE THE PATIENT. GENERATOR USED: VALLEY LAB. GENERATOR SETTINGS: BIPOLAR AT 12. PRODUCT WAS NOT CHANGED OUT AS THE VEIN HARVEST WAS ALREADY DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877230 ↗
• MalfunctionDec 23, 2025Melted; Sparking; Melted; Sparking

  ADDITIONAL INFORMATION WAS RECEIVED INDICATES THAT AN OLYMPUS ESG400 GENERATOR WAS USED. PER THE CLINICAL SPECIALIST, THE PROPER ESG-400 SETTING THAT UTILIZES AN EFFECT SETTING OF 3 IS TO BE ONLY USED WITH A COAG SETTING OF 8. THERE SHOULD BE NO CUT SETTING PROGRAMMED INTO THE OLYMPUS ESG-400 GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876086 ↗
• InjuryDec 5, 2025Failure to Conduct; Failure to Conduct

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731306 ↗
• InjuryDec 5, 2025Failure to Conduct; Failure to Conduct

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731252 ↗
• InjuryDec 5, 2025Failure to Conduct; Failure to Conduct

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731246 ↗
• MalfunctionNov 6, 2025Smoking; Sparking; Smoking; Sparking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE TIP OF THE ELECTROSURGICAL KNIFE EMITTED SMOKE AND SPARKS. THE UNIT WAS USED TO HARVEST THE GREAT SAPHENOUS VEIN. SPARKS WERE OBSERVED AT THE FRONT END OF THE CONSUMABLE, AND A SMALL HOLE WAS BURNED THROUGH. IT IS NO LONGER FUNCTIONAL; THEREFORE, NO ADJUSTMENTS WERE MADE. THE UNIT WAS CHANGED OUT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A VALLEYLAB GENERATOR WAS USED, WITH A GENERATOR SETTING OF 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491219 ↗
• MalfunctionOct 30, 2025Melted; Smoking; Melted; Smoking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, THE TIP WAS MELTED. THE HARVESTER SMELLED BURNING PLASTIC AND SAW SMOKE ON SCREEN WHEN USING THE YELLOW (CUT) FOOT PEDAL DURING THE SAPHENOUS VEIN HARVEST USING VIRTUOSAPH PLUS (VSP). THE FOOT PEDAL WAS USED TWICE AND IT DID NOT SEEM RIGHT, SO THE DEVICE WAS PULLED IT OUT OF THE LEG AND EXAMINED. THE FOOT PEDAL (CUT-YELLOW) WAS HIT ONCE MORE IN THE AIR AND SAW THE SMOKE AND MELTING AT A SMALL SECTION BELOW THE GROUNDING PADS ON THE DEVICE. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429810 ↗
• MalfunctionOct 24, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT A VALLEY LAB GENERATOR WAS USED, IT WAS ON A BIPOLAR SET, MACRO ON 6, AND THE SETTINGS WERE NOT MODIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384525 ↗
• MalfunctionAug 21, 2025Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, WHEN PATIENT UNDERWENT CORONARY ARTERY BYPASS SURGERY, THE V-CUTTER'S BODY HAD BURNED. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866295 ↗
• InjuryAug 1, 2025Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE HARVESTER PIN FOR THE BASKET SLIPPED CAUSING A TEAR IN THE VEIN. AS PER THE USER FACILITY, THE LOCKING MECHANISM WITH THE GREEN BUTTON WAS FULLY PUSHED IN, BUT THE PIN SEEMED TO BE LOOSE AND NOT KEEPING IT LOCKED. BASICALLY, THE PIN ON THE V-KEEPER DID NOT CLOSE ALL THE WAY, EVEN THOUGH IT WAS FULLY IN POSITION AND ALLOWED THE VEIN TO BE DAMAGED. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687403 ↗
• InjuryAug 1, 2025Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE HARVESTER PIN FOR THE BASKET SLIPPED CAUSING A TEAR IN THE VEIN. AS PER THE USER FACILITY, THE LOCKING MECHANISM WITH THE GREEN BUTTON WAS FULLY PUSHED IN, BUT THE PIN SEEMED TO BE LOOSE AND NOT KEEPING IT LOCKED. BASICALLY, THE PIN ON THE V-KEEPER DID NOT CLOSE ALL THE WAY, EVEN THOUGH IT WAS FULLY IN POSITION AND ALLOWED THE VEIN TO BE DAMAGED. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687401 ↗
• InjuryJun 26, 2025Break; Break

  DURING THE PERIODIC RISK REVIEW FOR VSP550EX PRODUCT, A MAUDE DATABASE SEARCH WAS PERFORMED, AND A COMPLAINT WAS FOUND THAT WAS NOT REPORTED TO TCVS. AN ELDERLY MALE WITH HISTORY OF POOR CIRCULATION OF RIGHT LOWER EXTREMITY. PROCEDURE WAS RIGHT ILIOFEMORAL ENDARTERECTOMY WITH ILIAC STENTING AND RIGHT FEMORAL TO POSTERIOR TIBIAL BYPASS. WHILE THEY WERE CAUTERIZING, THE TIP OF THE DEVICE BROKE OFF. THEY WERE ABLE TO BE REMOVED FROM THE PATIENT AND NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342449 ↗
• MalfunctionMay 16, 2025Flare or Flash; Flare or Flash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO VEIN HARVESTING PROCEDURE, DURING SETUP, THE DEVICE CAUGHT A FLAME WHEN DIATHERMY/CAUTERIZATION WAS TESTED. AS PER USER FACILITY, THE DEVICE WAS PREPPED AND READY TO BE USED FOR HARVESTING. THE DEVICE CAUGHT A FLAME WHEN DIATHERMY/CAUTERIZATION WAS TESTED. HAPPENED BEFORE HARVESTING STARTED. CASE CONTINUED WITH USE OF NEW DEVICE. IT WAS DISCOVERED THAT THE INCORRECT DIATHERMY GENERATOR (ERBE GENERATOR) WAS USED IN CONJUNCTION WITH THE VIRTUOSAPH DEVICE WHEN THE INCIDENT OCCURRED. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035820 ↗
• InjuryMay 8, 2025Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT'S LEG. THERE WAS APPROXIMATELY A 10-MINUTE DELAY OCCURRED IN THE CASE DUE TO SEARCHING FOR MISSING/BROKEN PIECE AND OBTAINING REPLACEMENT DEVICE, ALL PIECES WERE RETRIEVED. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989776 ↗
• MalfunctionMay 8, 2025No Flow; No Flow

  A MEDSUN REPORT (B)(4) WAS RECEIVED WITH A DESCRIPTION OF; THE CARBON DIOXIDE (CO2) WAS NOT COMING OUT OF THE END OF THE HARVESTER AS IT SHOULD. THE PROBLEM OCCURRED DURING SETUP. *NO PATIENT INVOLVEMENT, *PRODUCT WAS CHANGED OUT, *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989649 ↗
• InjuryApr 1, 2025Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, DURING VEIN HARVESTING PROCEDURE, A PIECE OF PLASTIC FROM THE V CUTTER BROKE OFF. AS PER USER FACILITY, THE HARVESTER WAS REMOVED FROM THE OPERATING TABLE AFTER TAKING PHOTOS OF THE BROKEN PART AND ENSURING THERE WERE NO OTHER BROKEN/MISSING PARTS. A THOROUGH ENDOSCOPIC EXPLORATION OF THE SURGICAL SITE WAS PERFORMED WITH THE NEW KIT TO ENSURE THERE WAS NO DAMAGE/INJURY CAUSED TO THE PATIENT OR ANY PLASTIC PARTS WERE LEFT IN THE EVH TUNNEL. THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE NEW KIT OPENED. THERE WAS NO BLOOD LOSS OR HARM CAUSED TO THE PATIENT. THE BRAND THEY USED WAS AN OLYMPUS ESG-400, WITH A SETTINGS OF BIPOLAR COAG EFFECT 3, 12. THE SETTING WAS NOT MODIFIED DURING THE CASE. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746687 ↗
• InjuryMar 28, 2025Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THE TIP HAS BROKEN OFF. THE PIECE WAS LEFT IN THE PATIENT, AND IT WAS RETRIEVED SUCCESSFULLY. THE USER WAS MIDWAY THROUGH THE HARVESTING, THE THIGH WAS HARVESTED, AND THE PROBLEM OCCURRED WHILE HARVESTING THE BOTTOM LEG. PRODUCT WAS CHANGED OUT PROCEDURE COMPLETED SUCCESSFULLY WITH 10 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719128 ↗