Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System because one energy platform is not compatible with the device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a compatibility issue with an energy platform that has been corrected in the documentation. No injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number VSP550EX, Lot Number 81K. The device is indicated for use in minimally invasive surgery for vessel harvesting, primarily for patients undergoing endoscopic surgery for arterial bypass.
The recall was initiated because recent reports indicate that one energy platform is not compatible with the system. Consequently, this platform has been removed from the list of compatible generators in the Instructions for Use (IFU). The affected products were distributed worldwide, including in the United States (Florida, Illinois, New York, Ohio, Texas) and Singapore.
Healthcare providers and facilities that have received this product should stop using the affected units and contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall.
The recalled product
- 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
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 135
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 81K
Distribution
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