Virtuosaph Endoscopic Vein Harvesting System MCVS550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753018945), received between May 3, 2021 and May 3, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2021Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING VEIN HARVESTING, THE HEAD OF DISSECTOR SEPARATED FROM THE BODY DURING DISSECTION. THE DISSECTOR HEAD BROKE OFF IN THE PATIENT, BUT WAS IMMEDIATELY REMOVED WHEN THEY FOUND IT. NO BROKEN PIECE REMAINED IN THE PATIENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759572 ↗

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,