Terumo Cardiovascular Systems Corporation recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endos…

Recall date

August 31, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0227-2019

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 requit¿ing 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