美国食品和药物管理局将Inari医疗公司的NARI ClotTriever导管召回作为"最严重"由于不良事件. FDA classifies Inari Medical's NARI ClotTriever catheter recall as "most serious" due to adverse events.
由于有严重不良事件的报道,包括设备陷入和肺动脉阻塞,FDA将Inari Medical的NARI ClotTriever导管装置召回分类为"最严重". FDA classifies Inari Medical's NARI ClotTriever catheter device recall as "most serious" due to reports of serious adverse events, including device entrapment and lung artery blockage. 重新召回会影响标记日期在8月1日之前的所有装置,包括更新使用指示、程序和反证。 The recall affects all devices with labeled dates before August 1 and involves updating the use instructions, procedures, and contraindications. 美国食品和药物管理局建议医疗保健提供者认为该设备在特定情况下是禁用的,并警告说,凝块捕获设备尚未在静脉血管中被证明有效. The FDA has recommended healthcare providers consider the device contraindicated for specific cases and warns that a clot capture device has not yet been demonstrated effective in venous vasculature.