Recall Z-0227-2019— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0227-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-31

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2018-08-31, terminated 2019-10-21. It names one FDA 510(k) clearance: K140008. 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 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. 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..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-08-31
Terminated: 2019-10-21
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K140008 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEMTerumo Cardiovascular Systems Corporation·cleared 2014-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.