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
stent - Product Code FGE
원인
Two individual ev3 protege gps biliary stent system devices were incorrectly labeled as serb65-09-60-120 and the actual device is serb65-12-60-80. length is shorter than expected.
조치
Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.