U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Circulatory Support System - Product Code DSQ
원인
Unit may alarm ''low flow'' and ''low pressure'' due to manufacturing material in the pressure source.
조치
Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.