Stent, Colonic, Metallic, Expandable
General, Plastic Surgery · 21 CFR 878.3610
Recent MDR events
1,319 adverse event reports on file
- WALLFLEX? COLONICJul 20, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02942
- NITI-S ENTERAL COLONIC UNCOVERED STENTJul 7, 2026InjuryTaewoong Medical Co.,ltd.3003902943-2026-00015
- WALLSTENT? ENTERAL ENDOPROSTHESISJul 1, 2026DeathBoston Scientific Corporation3005099803-2026-02644
- EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVEREDJun 10, 2026MalfunctionCook Ireland Ltd3001845648-2026-00225
- NITI-S ENTERAL COLONIC UNCOVERED STENTJun 4, 2026InjuryTaewoong Medical Co.,ltd.3003902943-2026-00013
- WALLFLEX? COLONICJun 3, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02288
- NITI-S ENTERAL COLONIC UNCOVERED STENTMay 20, 2026InjuryTaewoong Medical Co.,ltd.3003902943-2026-00011
- WALLFLEX? COLONICMay 13, 2026InjuryBoston Scientific Corporation3005099803-2026-01875
- EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVEREDMay 12, 2026MalfunctionCook Ireland Ltd3001845648-2026-00172
- EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVEREDApr 3, 2026MalfunctionCook Ireland Ltd3001845648-2026-00123
Event type breakdown
Recalls
2 recall events for this product code
- Boston Scientific CorporationTerminatedAug 31, 2010
Boston Scientific Ultraflex Precision Colonic Stent System
Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
Z-2331-2010 · View FDA record ↗ - SPS Sterilization, IncTerminatedUnknown
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Z-3038-2018 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Synergy Health Ast, Srl
Alajuela, CR
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Boston Scientific Corporation
Marlborough, MA, US
Synergy Health Westport Ltd
Westport Mayo, IE
M.i.tech Co Ltd
Pyeongtaek Gyeonggi, KR
Boston Scientific Corporation
Coventry, RI, US
Taewoong Medical Co., Ltd
Gimpo-Si Gyeonggi, KR
M.i.tech Co., Ltd.
Jeonju Jeonbuk, KR
M.i.tech Co., Ltd.
Seoul, KR
Cook Medical Llc
Bloomington, IN, US
Cook Medical Eudc Gmbh
Baesweiler North Rhine-Westphalia, DE
Cook Ireland Ltd
LIMERICK, IE
Boston Scientific Limited
GALWAY, IE
510(k) clearances
16 clearances for this product code
- Boston Scientific CorporationMar 8, 2024
K234046 · WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- Boston Scientific CorporationAug 17, 2020
K201159 · WallFlex Colonic Stent System with Anchor Lock Delivery System
- Boston Scientific CorporationApr 17, 2020
K200257 · WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- M.I.Tech Co., Ltd.Mar 7, 2019
K190141 · HANAROSTENT LowAx Colon/Rectum (NNN)
- M.I.Tech Co., Ltd.Jan 10, 2019
K183616 · HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
- M.I.Tech Co., Ltd.Nov 2, 2018
K180180 · HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
- Cook Ireland, Ltd.May 17, 2012
K113510 · EVOLUTION COLONIC STENT SYSTEM
- Boston Scientific CorpSep 15, 2006
K061877 · WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM