Z-0227-2019Class II

VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX

Name: Z-0227-2019 VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-08-31
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-08-31 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX... on 2018-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0227-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-31
Posted: 2018-10-24
Terminated: 2019-10-21
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiting blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting vc
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Correction notification letters dated August 29, 2018 were distributed to customers. The letter identified the affected product, problem and actions to be take. Customers were instructed to: Review this Medical Device Correction Notification and the Recommended Actions. Assure that all users receive notice of this issue. Confirm receipt of this correction notification by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. Ensure that users are notified of the revised IFU provided with this notification (Revision 3) and that it replaces any previous versions at all points of use within your facility. If you wish to return Revision 2 of the IFU to Terumo CVS, follow your complaint reporting protocol and contact Terumo CVS. For questions contact Terumo CVS Customer Service 1-800-521-2818.
Quantity in commerce: 135
Distribution: Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.
Product codes and lots: Lot Numbers: 81K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0227-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0227-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code GEI

K140008Class IIVirtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation / cleared 2014-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)