According to a medical device recall notice posted on the Food and Drug Administration (FDA) website, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and Vici RDS venous stent system due to reported instances of stent migration. The FDA has identified this as a Class I recall.
The FDA announcement details that Boston Scientific initiated the recall on 12 April “after reports indicate that the stents may migrate or move from where they are initially implanted.”
Outlining the risks associated with stent migration, the statement reads: “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 migrated to the heart, it could cause life-threatening injury.”
There have been 17 complaints and reported injuries related to this issue, the notice states, which adds that no deaths have been reported.
Boston Scientific has asked customers to “immediately discontinue use of the device” and “remove all affected units from inventory and secure them.” The FDA statement urges customers with questions to contact their Boston Scientific representative.
The full FDA medical device recall notice can be found here.