Pancreatic Stent, Covered, Metallic, Removable
Gastroenterology, Urology · 21 CFR 876.5015
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Recent MDR events
2,138 adverse event reports on file
- AXIOS Stent and Electrocautery Enhanced Delivery SystemJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03115
- AXIOS Stent and Electrocautery Enhanced Delivery SystemJul 30, 2026InjuryBoston Scientific Corporation3005099803-2026-03094
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 21, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02974
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 17, 2026InjuryBoston Scientific Corporation3005099803-2026-02925
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 16, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02871
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 15, 2026InjuryBoston Scientific Corporation3005099803-2026-02843
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 14, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02809
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 13, 2026InjuryBoston Scientific Corporation3005099803-2026-02792
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 13, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02794
- AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMJul 6, 2026InjuryBoston Scientific Corporation3005099803-2026-02684
Event type breakdown
Recalls
6 recall events for this product code
- Boston Scientific CorporationTerminatedUnknown
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and sh
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Z-0773-2021 · View FDA record ↗ - Boston Scientific CorporationTerminatedUnknown
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and sh
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Z-0774-2021 · View FDA record ↗ - Boston Scientific CorporationTerminatedUnknown
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and sh
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Z-0775-2021 · View FDA record ↗ - Boston Scientific CorporationTerminatedUnknown
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 d
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Z-0776-2021 · View FDA record ↗ - Boston Scientific CorporationTerminatedUnknown
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 d
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Z-0777-2021 · View FDA record ↗ - Boston Scientific CorporationTerminatedUnknown
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 d
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Z-0778-2021 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
510(k) clearances
11 clearances for this product code
- Taewoong Medical Co., Ltd.Mar 13, 2026
K252648 · Niti-S SPAXUS Stent
- Boston Scientific CorporationSep 7, 2022
K220112 · AXIOS Stent and Electrocautery-Enhanced Delivery System
- Boston Scientific CorporationApr 15, 2021
K203132 · AXIOS Stent and Electrocautery Enhanced Delivery System
- Boston Scientific CorporationAug 26, 2019
K192043 · AXIOS Stent and Electrocautery Enhanced Delivery System
- Boston Scientific CorporationMar 25, 2019
K181905 · AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
- Boston Scientific CorporationFeb 18, 2017
K163272 · AXIOS Stent and Electrocautery Enhanced Delivery System
- Boston Scientific CorporationDec 11, 2015
K153088 · AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
- Boston Scientific CorporationOct 6, 2015
K152572 · AXIOS Stent and Delivery System