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
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
원인
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. an investigation found that 6fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6fr 120 cm (.035') were labeled as 6fr, 135 cm (.018').
조치
Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.