(CNN, 2024-4-1)

There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation①, according to an alert issued by the pump’s manufacturer and posted on the US Food and Drug Administration’s website.

美国食品药品监督管理局（FDA）网站上公布了一份由心脏泵制造商发布的警报，制造商在警报中称，他们更新修订了某型号心脏泵使用说明的注意事项，该款心脏泵或有致心脏穿孔的风险。

The pumps, left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed, have been linked to more than 100 serious injuries, including 49 deaths.

这款 Impella 左侧心脏泵由强生医疗科技公司旗下的阿比奥梅德生产，目前已导致100多人严重受伤，其中49人死亡。

“The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle② perforation or free wall rupture③, hypertension④, lack of blood flow, and death,” Abiomed said. 

阿比奥梅德称：“使用有问题的 Impella 心脏泵可能导致严重健康后果，包括左心室穿孔或游离壁破裂、高血压、供血不足，以及死亡。”

More than 66,000 devices in the US are affected by this alert.  The FDA said people with specific risks related to the device may include women, the elderly and people with previous heart attacks that affected the front wall of the heart⑤.

美国有超过6.6万台该警报所涉及的问题心脏泵。FDA 表示，与这款心脏泵相关的特定风险人群可能包括女性、老年人和心前壁损伤的心脏病史者。

【注释】

① perforation: [ˌpɜːfəˈreɪʃn] n. the process of splitting or tearing in such a way that a hole is left 穿孔；穿通。

② ventricle: [ˈventrɪkl] n. either of the two lower spaces in the heart that pump blood to the lungs or around the body 心室。

③ rupture: [ˈrʌptʃə(r)] n. an injury in which sth inside the body breaks apart or bursts （体内组织等的）断裂，破裂。

④ hypertension: [ˌhaɪpəˈtenʃn] n. blood pressure that is higher than is normal 高血压。

⑤front wall of the heart: 心前壁，也可以用来指代左心室的前壁。心前壁是一块承受着巨大压力的心肌组织。它是心脏的主要泵浦区域之一,承担着将血液从左心室泵入主动脉的重要功能。