Reported May 26, 2021 · Ongoing
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- VICI
- RDS VENOUS STENT System Product Usageis indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction
- Lot codes and dates
- all batches/lots of the device manufactured between May 2018 through April 2021
- Amount recalled
- 34,248 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The firm has received reports of stent migration after implantation
Using this product could cause serious injury, illness or death — stop using it now.
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