VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
FDA Recall Z-1069-2014 · Posted 2014-02-21
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2013-12-12
Date Terminated2015-07-28
Product Quantity26 units
Reason for Recall
Sterility of medical devices intended for use in surgical procedures may be compromised.
Firm Action
Terumo CVS notified afected end users by phone on December 12, 2013 and advised that they had become aware that the sterile packaging barrier was breached in specific lots of VirtuoSaph Plus Endoscopic Vessel Harvesting Systems. Customers were requested to return all unused affected product and verify that all users at their institution have been made aware of the risks associated with using the affected devices. For questions call 734-663-4145.
Root Cause
Process control
Distribution Pattern
USA Nationwide Distribution in the state of LA, NJ, and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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