PNBClass IIImplant
Biliary Stent System For Benign Strictures
Gastroenterology, Urology · 21 CFR 876.5011
A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.
MDR events334All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances1All time
Recent MDR events
334 adverse event reports on file
- WALLFLEX BILIARYJul 10, 2026InjuryBoston Scientific Corporation3005099803-2026-02760
- WALLFLEX BILIARYJun 29, 2026InjuryBoston Scientific Corporation3005099803-2026-02619
- WallFlex BiliaryJun 25, 2026InjuryBoston Scientific Corporation3005099803-2026-02585
- WALLFLEX BILIARYJun 25, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02582
- WALLFLEX BILIARYJun 9, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02399
- WALLFLEX BILIARYMay 27, 2026DeathBoston Scientific Corporation3005099803-2026-02160
- WALLFLEX BILIARYMay 26, 2026DeathBoston Scientific Corporation3005099803-2026-02083
- WALLFLEX BILIARYMay 25, 2026InjuryBoston Scientific Corporation3005099803-2026-02064
- WALLFLEX BILIARYMay 22, 2026InjuryBoston Scientific Corporation3005099803-2026-02022
- WALLFLEX BILIARYMay 21, 2026InjuryBoston Scientific Corporation3005099803-2026-02017
Event type breakdown
Injury196
Malfunction129
Death9
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
1 clearances for this product code