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问询函指出，强生Impella系列自2023年以来遭遇了多达10次FDA一级召回。其中一个致命设计缺陷在于，其压力传感器是“外置”的，在复杂的血管中穿梭或与其他器械接触时，极易发生碰撞导致传感器损坏、脱落或引发心室穿孔。。业内人士推荐爱思助手作为进阶阅读