FDAClass IMay 26, 2021

VICI VENOUS STENT System Product Usage: is intended for recall

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

Why was VICI VENOUS STENT System Product Usage: is intended for recalled?

The firm has received reports of stent migration after implantation

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

all batches/lots of the device manufactured between May 2018 through April 2021

Product
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Recalling firm
Boston Scientific Corporation
Quantity
550 units
Distribution
Worldwide - US Nationwide Distribution
Recall date
May 26, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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