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
Embolic Protection System - Product Code NFA
원인
Alarm activiation-a priming issue involving the flow control unit due to a software problem has caused false postive extraction line block (elb) alarming. use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting.
조치
The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
The product was shipped to hospitals in Germany and Italy.
제품 설명
TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.