Boston Scientific recalls venous stents because of migration ... | 合法醫療器材資訊網

2021年5月24日—DiveBrief:·BostonScientificisrecallingallViciSDSandViciRDSvenousstentsystemsdistributedovera30-monthperiodinlightof17 ...

Boston Scientific is recalling all Vici SDS and Vici RDS venous stent systems distributed over a 30-month period in light of 17 complaints about the products.[1]

Users complained the devices may move from where they are implanted, creating a need for follow-up procedures and a risk of life-threatening injury. No deaths have been reported but FDA categorized the recall as a Class I event, its most serious designation.

Boston Scientifics pursuit of the venous stent opportunity has suffered a setback. The company is recalling all 31,798 Vici SDS and Vici RDS&...