Medical device recall

Boston Scientific Recalls Venous Stent System Due Device Migration

By MedTech Intelligence Staff
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Medical device recall

Nearly 32,000 stent systems have been recalled in the United States.

Boston Scientific has recalled the VICI SDS and VICI RDS Venous Stent Systems due to the potential for stent migration from the location of original implantation. The stent systems are used to treat obstructions and occlusions in narrowed or blocked venous veins.

The Class I recall involves 31,798 devices in the United States; the products were distributed between September 21, 2018 and April 9, 2021. Thus far there have been 17 complaints and reported injuries related to the device problem. No deaths have been reported.

On April 12, Boston Scientific sent an Urgent Medical Device Recall Notification to customers requesting they immediately discontinue device use and to remove affected units from inventory.

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