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
Biliary Stent - Product Code FGE
원인
A primus device labeled (pouch and box) as a bxb35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
조치
ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.
Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
제품 설명
ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.