
10月15日 - 美国食品和药物管理局周四警告称,在经导管 mitral 瓣膜置换术中使用的某些爱德华兹生命科学输送系统存在潜在高风险问题,此前已导致一起死亡和一起严重受伤。
Oct 15 - The US FDA on Thursday warned of a potentially high-risk issue involving certain Edwards Lifesciences delivery systems used in transcatheter mitral valve replacement after one death and one serious injury.
FDA表示,爱德华兹生命科学已要求客户停止使用受影响的设备并退回相关产品。
The FDA said Edwards Lifesciences had asked customers to remove affected devices from use and return impacted products.