Lower riskMedical device recall · FDA · Published August 31, 2018
Terumo VirtuoSaph Plus Endoscopic Vessel Harvesting System Recall: Generator Compatibility
Terumo recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System (VSP550EX) due to a generator compatibility issue that could affect surgical safety. Affected units may require specific generator checks.
The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU.
Take action
Contact the company
📍Recalling firmTerumo Cardiovascular Systems Corporation125 Blue Ball Rd · Elkton, MD 21921-5315
“Terumo VirtuoSaph Plus Endoscopic Vessel Harvesting System Recall: Generator Compatibility.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69927-terumo-virtuosaph-plus-endoscopic-vessel-harvesting-system-recall-generator-compatibility. Based on FDA recall #Z-0227-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0227-2019%22&limit=1).
The FDA announced on August 31, 2018, that Terumo Cardiovascular Systems Corporation is recalling the VirtuoSaph Plus Endoscopic Vessel Harvesting System because its instructions for use incorrectly list a compatible energy platform. The company has removed the incompatible generator from the list within the IFU.
How to tell if you have it
Brand: Terumo
Product: VirtuoSaph Plus Endoscopic Vessel Harvesting System
Catalog Number: VSP550EX
Lot Numbers: 81K
The hazard
The system's instructions for use (IFU) contained a list of generators deemed compatible, but recent reports indicate one energy platform is not compatible with the system. Consequently, that generator has been removed from the list of compatible generators within the IFU.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls include the Terumo CDI OneView BPM Probe Recall (May 28, 2025), the Terumo CDI OneView Hematocrit Probe recall (March 3, 2025), and the Terumo Cardiovascular Procedure Kits with High Crack Check Valve Risk of Myocardial Damage (February 20, 2024). Other recent recalls of similar products include the Olympus OER-Elite Endoscope Reprocessor Recall (February 12, 2026), the Maquet Vasoview Hemopro 2 Gamma Sterilization Issue (June 2, 2026), and the Olympus OER-Pro Endoscope Reprocessor Recall (February 12, 2026).
How to tell if you have this one
Check for the catalog number VSP550EX on the device. The product was sold with lot number 81K. This recall applies to the VirtuoSaph Plus Endoscopic Vessel Harvesting System used in minimally invasive surgery.
Brand
Terumo
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Generator Compatibility
Verify that the generator used with the system is listed as compatible in the instructions for use (IFU).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Illinois, New York, Ohio, Texas.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0227-2019 (August 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0227-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.