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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.