Due to concerns that stents can migrate from where they are initially implanted, Boston Scientific has recalled the Vici SDS and RDS venous stent systems. According to the FDA, there have been 17 reports and injuries related to this medical device recall, but no deaths have been confirmed.
The Vici SDS and RDS venous stent devices treat obstructions and occlusions in venous veins that are narrowed or blocked. A migrated stent can necessitate additional surgery or a catheter procedure to retrieve it, increasing the patient’s risk of damage to the blood vessel, heart walls, or other organs. The stent could cause life-threatening injury if it migrates to the heart.
According to the FDA note, the recall covers 31,798 devices distributed between September 21, 2018, and April 9, 2021. The recall was initiated on April 12, but the FDA only announced it late Friday, classifying it as a Class I recall, the most extreme form of a medical device recall.
Customers are urged to follow Boston Scientific guidelines in an urgent medical device recall warning, which immediately stops the use of the recalled products. Customers can contact their Boston Scientific sales representative if they have any concerns about the recall. So far, in 2021, the FDA has released 20 medical device recall notices. Last year at this time, the FDA had released 17 medical device recall notices.