FDA deemed Boston Scientific’s recall of the Vici SDS and RDS venous stent systems a Class I recall, reports MDDI.
Boston Scientific is recalling the Vici SDS and RDS venous stent system due to concerns that stents may migrate from where they are initially implanted. FDA said there have been 17 complaints and reported injuries related to this medical device recall, but no reported deaths.
The Vici SDS and RDS venous stent systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous 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. If the stent migrates to the heart, it could cause life-threatening injury.
Read more at MDDI.