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
Artificial Heart - Product Code LOZ
원인
Subassembly incorrectly aligned.
조치
Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.
Abiomed : Abiocor Implantable Heart Replacement Kit System || Catalog Number:: 0034-8401-HD || The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.