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
美国食品药品管理局说，波士顿科学召回用于下消化道出血的Obsidio合成栓塞，以增加肠道缺血的风险；波士顿科学召回是一种更正，不是一类召回的产品移除；报告了11起与黑曜石栓塞有关的事件，7人受伤，2人死亡