Terumo Cardiovascular Systems Corporation: 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

Recall number

Z-0227-2019

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

Status

Terminated

Initiated

2018-08-31

Posted

not on file

Terminated

2019-10-21

Reason

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

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

135

Distribution

Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.

Lot, serial or model codes

Lot Numbers: 81K

510(k) numbers

["K140008"]

PMA numbers

not on file

Product code

GEI

Firm FEI

3000204839

Firm city

Elkton

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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