由于 Abiomed 设备存在导管风险，FDA 召回了 66,000 台 Impella 左侧血泵（49 人死亡，100 多人受伤）。 66,000 Impella Left Sided Blood Pumps (49 deaths, 100+ injuries) recalled by FDA due to catheter risk in Abiomed devices.
美国食品和药物管理局 (FDA) 对 Abiomed 生产的 66,000 多台 Impella 左侧血泵发出 I 级召回通知，导致 49 人死亡和 100 多人重伤。 The US Food and Drug Administration (FDA) has issued a Class I recall for over 66,000 Impella Left Sided Blood Pumps manufactured by Abiomed, linking them to 49 deaths and over 100 serious injuries. 此次召回是最严重的类型，是由于泵导管存在危险而启动的，该导管在手术过程中可能会切穿左心室壁。 The recall, the most serious type, was initiated due to the danger associated with the pump's catheter, which may cut through the wall of the left ventricle during operations. 这些设备用于在高风险导管手术期间以及心脏病发作、心脏直视手术或心肌病后发生心源性休克的情况下支持心脏泵血。 The devices are used to support heart pumping during high-risk catheter-based procedures and in cases of cardiogenic shock following heart attacks, open-heart surgery, or cardiomyopathy. Abiomed 于 2023 年 12 月向受影响的客户发送了一封紧急医疗器械纠正信，要求他们遵循新的和修订的警告。 Abiomed sent an Urgent Medical Device Correction letter to affected customers in December 2023, requesting they follow new and revised warnings. 召回的泵的销售时间为2021年10月10日至2023年10月10日。 The recalled pumps were distributed from October 10, 2021, to October 10, 2023.