FDA Says Boston Scientific Recalls Obsidio Conformable Embolic For Increased Bowel Ischemia Risk When Used For Lower GI Bleeding; Boston Scientific Recall Is A Correction, Not A Product Removal as A Class I Recall;11 Incidents Reported, Seven Injuries, And Two Deaths Related To Obsidio Embolic
美國食品藥品管理局說,波士頓科學召回用於下消化道出血的Obsidio合成栓塞,以增加腸道缺血的風險;波士頓科學召回是一種更正,不是一類召回的產品移除;報告了11起與黑曜石栓塞有關的事件,7人受傷,2人死亡