FDA (Devices) recall action 87721
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The firm has received reports of stent migration after implantation
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Boston Scientific is recalling VICI Venous Stent Systems because the company received reports of stent migration after implantation.
Boston Scientific is recalling VICI RDS Venous Stent Systems manufactured between May 2018 and April 2021 due to reports of stent migration after implantation.