The medical device manufacturer Boston Scientific has recalled 31,798 Vici Venous Stent Systems due to a risk of injury or death.
The recalled Vici SDS and Vici RDS Venous Stent Systems are used to treat blocked veins or obstructions in narrow veins.
Unfortunately, reports suggest that the stents can migrate or move out of place from where they were initially implanted.
The FDA designated the recall as Class 1, which is the most serious type of recall for devices that may cause severe injuries or death.
The FDA warns that “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.”
No deaths were reported, but if the stent migrates to the heart, it could cause death or a life-threatening injury.
There were 17 complaints and reported injuries related to the problem, but no deaths were reported.
The recalled stents were distributed in the U.S. between September 21, 2018 through April 9, 2021.
Boston Scientific is asking customers to immediately stop using the device and return them to the company.