FDA designates recall of two venous stent systems as class I
The FDA has identified Boston Scientific’s recall of two venous stent systems as class I, the most serious type of recall, due to risk for stent migration that may cause injury or death.
The two stent systems (Vici and Vici RDS, Boston Scientific) are intended for the treatment of obstructed and occluded venous veins and were distributed between Sept. 21, 2018, and April 9, 2021.
According to a press release from the FDA, a migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including damage to the blood vessel, heart walls or other organs. If the stent migrates to the heart, it may cause life-threatening injury.
There have been 17 complaints and reported injuries but no deaths associated with the stent systems, according to the release.