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.
Reported: March 5, 2014 Initiated: December 12, 2013 #Z-1069-2014
Product Description
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.
Reason for Recall
Sterility of medical devices intended for use in surgical procedures may be compromised.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 26 units
- Distribution
- USA Nationwide Distribution in the state of LA, NJ, and NY.
- Location
- Elkton, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 26 units.
Why was this product recalled? ▼
Sterility of medical devices intended for use in surgical procedures may be compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1069-2014.
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