QXHClass IIImplant
Gallbladder Drainage Stent And Delivery System
Gastroenterology, Urology · 21 CFR 876.5016
A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.
MDR events108All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
108 adverse event reports on file
- AXIOS Stent and Electrocautery Enhanced Delivery SystemJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03125
- AXIOS Stent and Electrocautery Enhanced Delivery SystemJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03128
- Axios?Jul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03129
- Axios?Jul 30, 2026InjuryBoston Scientific Corporation3005099803-2026-03098
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02839
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 9, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02736
- AXIOS Stent and Electrocautery Enhanced Delivery SystemJul 7, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02714
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 2, 2026InjuryBoston Scientific Corporation3005099803-2026-02654
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJun 29, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02616
- AXIOS?Jun 5, 2026DeathBoston Scientific Corporation3005099803-2026-02324
Event type breakdown
Malfunction59
Injury41
Death8
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code