FDA: Class I recall of Boston Scientific’s VICI, VICI RDS Venous Stent systems

Editor's Note

The Food and Drug Administration (FDA), on May 21, identified the recall by Boston Scientific Corporation of its VICI Venous Stent and VICI RDS Venous Stent systems as Class I, the most serious.

The recall was initiated because of reports that the stents may migrate or move from where they were implanted. The stent systems are used for the treatment of obstructions and occlusions in narrowed or blocked veins.

There have been 17 complaints and reported injuries. No deaths have been reported.

Distribution dates were September 21, 2018 to April 9, 2021.