VICI RDS VENOUS STENT System Product Usage: is recall
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic…
Why was VICI RDS VENOUS STENT System Product Usage: is 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 RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 34,248 units
- Distribution
- Worldwide - US Nationwide Distribution
- Recall date
- May 26, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)