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U.S. Department of Health and Human Services

Class 2 Device Recall VirtuoSaph Plus Endoscopic Vessel Harvesting System

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 Class 2 Device Recall VirtuoSaph Plus Endoscopic Vessel Harvesting Systemsee related information
Date Initiated by FirmAugust 31, 2018
Create DateOctober 24, 2018
Recall Status1 Terminated 3 on October 21, 2019
Recall NumberZ-0227-2019
Recall Event ID 81094
510(K)NumberK140008 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductVirtuoSaph 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
Code Information Lot Numbers: 81K
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information ContactTerumo CVS Customer Service
800-521-2818
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionUrgent 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 Commerce135
DistributionWorldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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