FDA announces recall of more than 30,000 Boston Scientific stent systems after numerous injuries
The FDA has announced that Boston Scientific is recalling more than 31,000 of its VICI SDS and VICI RDS venous stent systems.
The recall is due to the risk that the stents may move from where they were originally implanted.
“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,” according to the FDA. “If the stent migrates to the heart, it could cause life-threatening injury.”
This is a Class I recall, which means the issue can lead to serious injury or death. While 17 injuries have been reported to the FDA, there have been no deaths at this time.
In total, this recall affects 31,798 venous stent systems distributed to customers from September 2018 to April 2021.
Boston Scientific first initiated the recall on April 12, sending an urgent notice that asked all customers to immediately discontinue using these devices. All affected units should also be immediately removed from inventory. Local Boston Scientific representatives can help arrange any necessary returns.
The full FDA advisory is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.