FDA announces recall of more than 30 | 合法醫療器材資訊網

2021年5月21日—Searchform·TheFDAhasannouncedthatBostonScientificisrecallingmorethan31,000ofitsVICISDSandVICIRDSvenousstentsystems.

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.