争议事件
以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。
返回词条共 1 条
2021
Cardiovascular Systems 召回 Wirion 装置
宣布召回
Cardiovascular Systems Inc. 在收到取出装置时滤网破裂的报告后，开始在美国召回 Wirion 动脉粥样硬化切除术栓塞保护装置；FDA 将其列为第一级召回。
来源摘录
The company initiated the recall Nov. 22, 2021, when CSI sent an urgent notification recall letter to customers instructing them remove the device from distribution and return the device to Cardiovascular Systems Inc.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.