Vici Venous Stent Recall Follows Reports of Stent Migration
Boston Scientific is recalling nearly 32,000 vein stents, following reports suggesting the implants migrate out of place.
The FDA announced the Vici Venous and Vici RDS Venous stent system recall on May 21, indicating an announcement issued by the manufacturer qualifies as a Class I medical device recall, which is the most serious type of action and is reserved for situations where continued use poses a risk of serious injury or death.
The Vici Venous Stent system and Vici RDS Venous Stent system are intended to treat obstructions and occlusions in the narrowed or blocked venous veins. The device is placed surgically, to help open the blocked veins. However, Boston Scientific warns the stents may migrate or move from where they are initially implanted in the body.
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Stent migration may require a patient to have another surgery or catheter procedure to retrieve it. Stent migration and subsequent surgeries increase the risk to the patient, including possible damage to the blood vessel, heart walls, or other organs. If the stent migrates to the heart, it could cause life-threatening injuries and potentially lead to death.
To date, there have been 17 complaints and reported injuries related to the stents migrating out of position, but no deaths have been reported.
The FDA became aware of the problem in April, when Boston Scientific sent an Urgent Medical Device Recall Notification to customers, which asked them to immediately discontinue use of the device and remove them from inventory and secure them until they could be returned to the manufacturer.
The Vici Venous Stent System (Vici SDS) and the Vici RDS Venous Stent System recalls affects 34,248 devices recalled worldwide, 31,798 of those in the United States, distributed September 21, 2018, to April 9, 2021. A full list of model and serial numbers is available in the Medical Device Recall Database Entry.
Healthcare providers with questions concerning the VICI VENOUS and Vici RDS Venous Stent systems should contact Boston Scientific directly at (763) 494-1700.
Patients or healthcare professionals can report adverse reactions linked to the VICI stent systems by using the FDA’s MedWatch Adverse Event Reporting Program.
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