Boston Scientific stent recall is Class I | 合法醫療器材資訊網

2021年5月21日—“BostonScientificvoluntarilyinitiatedaglobalremovalofallnon-implantedVICIandVICIRDSvenousstentsystemsinApril2021dueto ...

Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. According to the FDA notice[2], the company recalled the stent systems following reports indicating that they may migrate or move from where they are initially implanted.

To date, there have been 17 complaints and reported injuries related to the issue of migration with the stents. No deaths have been reported, however.

Boston Scientific initiated the recall on April 12, 2021, with 31,798 affected devices distributed between Sep. 21, 2018, and April 9, 2021, included in the U.S. recall.

If a stent migrates or moves from the initial implant location, ...