已致4例死亡,美FDA对碧迪医疗一产品发布潜在高风险早期预警

新京报
19 Feb

因可能存在严重安全风险,美国食品药品监督管理局(FDA)近日对医疗器械巨头BD公司(碧迪医疗)一款名为Rotarex的外周斑块切除术装置发布了早期预警。由于该装置的螺旋桨在使用过程中可能有断裂或破损风险,进而导致血管损伤并引起严重出血或死亡。目前,BD公司已经报告了与此相关的30例重伤和4例死亡事件。记者查询国家药监局官网,目前该产品并未在国内销售。FDA官网发布的预警产品图片。已致4例死亡BD...

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