FDAClass IIOctober 31, 2018

VirtuoSaph Plus Endoscopic Vessel Harvesting System recall

VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System…

Why was VirtuoSaph Plus Endoscopic Vessel Harvesting System 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 81K

Product
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System…
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
135
Distribution
Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.
Recall date
October 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls