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
Ventricular (Assist) Bypass - Product Code DSQ
원인
The product is mislabeled, in that the lvad pneumatic lead 5' is identified with a blue collar (instead of red) in order to distinguish rvad.
조치
On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.