FDA Class I Recall of Some Boston Scientific Venous Stents

Megan Brooks

May 21, 2021

Boston Scientific Corporation has recalled its VICI SDS and VICI RDS venous stent systems in response to reports that the stents may migrate or move from where they are initially implanted.

The US Food and Drug Administration (FDA) classified this recall as class I, the most serious type, because of the potential for serious injury or death.

The VICI SDS and VICI RDS venous stent systems are intended for the treatment of obstructions and occlusions in narrowed or blocked veins.

"A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs," the FDA says in the recall notice. "If the stent migrates to the heart, it could cause life-threatening injury."

To date, there have been 17 complaints and reported injuries related to this issue. No deaths have been reported.

The recall covers 31,798 VICI venous stent systems distributed in the US between September 21, 2018 and April 9, 2021.

On April 12, Boston Scientific sent an urgent medical device recall letter to customers asking them to immediately discontinue use of the device; remove and secure all affected units from inventory; complete the company's verification form to acknowledge receipt and report products that will be returned; package affected products for shipping and contact the local Boston Scientific representative to arrange for their return.

The company says questions regarding this recall should be directed to local sales representatives. Healthcare professionals and consumers may report adverse reactions or quality problems with these devices to MedWatch, the FDA's adverse event reporting site.

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