—#167439

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

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K140008
Affected lot / code info: Lot Numbers: 81K

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

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

Timeline

Recall initiated: 2018-08-31
Terminated: 2019-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.