QIJClass II
Endoscopic Transhepatic Venous Access Needle
Gastroenterology, Urology · 21 CFR 876.1050
An endoscopic transhepatic venous access needle is inserted through the liver into the patients portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.
MDR events11All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
11 adverse event reports on file
- ECHOTIP INSIGHTFeb 14, 2025MalfunctionCook Ireland Ltd21383521
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEMJul 11, 2024MalfunctionCook Medical Ireland3001845648-2024-00363
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENTMay 27, 2024MalfunctionCook Ireland Ltd3001845648-2024-00234
- ECHOTIP INSIGHTJan 10, 2024MalfunctionCook Ireland Ltd18484251
- ECHOTIP INSIGHT ENDOSCOPIC ULTRASOUND NEEDLEOct 3, 2023InjuryCook Ireland Ltd3001845648-2023-00750
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEMJul 28, 2023MalfunctionCook Ireland Ltd3001845648-2023-00589
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEMJun 29, 2023MalfunctionCook Ireland Ltd3001845648-2023-00507
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEMOct 11, 2022MalfunctionCook Ireland Ltd3001845648-2022-00695
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEMSep 30, 2022MalfunctionCook Ireland Ltd3001845648-2022-00677
- ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENTJan 27, 2022InjuryCook Ireland Ltd3001845648-2022-00043
Event type breakdown
Malfunction9
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code