Virtuosaph Havester - Japan Only MCVS550HVJRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00699753021075), received between May 24, 2018 and Mar 10, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Conduct” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K083194); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2021Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, THE C02 WAS NOT INSUFFLATED. THE DEVICE WAS NOT USED AND SURGICAL INCISION WAS PERFORMED AS THE VEIN WAS THIN. SUBSEQUENTLY, THE SURGERY WAS COMPLETED SUCCESSFULLY. CO2 VALUE WAS SET AT 15MMHG (PRESSURE). CO2 FLOW RATE WAS SET TO 2 L/MIN AND THE PRESSURE TO 15 MMHG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456932 ↗
• InjurySep 7, 2018Failure to Conduct; Failure to Conduct

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THERE WAS A FAILURE IN ELECTRICAL CONTINUITY. IT WAS REPLACED THRICE BUT STILL FAILED; AS A RESULT, AN OPEN SURGICAL PROCEDURE WAS PERFORMED. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 7857511 ↗
• InjuryMay 24, 2018Failure to Conduct; Failure to Conduct

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING PROCEDURE, THERE WAS FAILURE IN THE ELECTRICAL CONTINUITY. THE HARVESTER WAS NOT USED AND SURGERY WAS CONVERTED TO OPEN VEIN HARVEST. PRODUCT WAS NOT CHANGED OUT, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 7542796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083194. One submission often covers many models, so check the product and lot details in each record.

• Z-1230-2011 · Jan 10, 2011 · Terminated
  Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI. The Terumo Bipolar cord MCBICORD1 is a flexible,