Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation's record for this product code
Recent MDR events
9,769 adverse event reports on file
- CRE PROJul 31, 2026Malfunction3005099803-2026-03111
- NaviFlex? PusherJul 31, 2026Malfunction3005099803-2026-03114
- NaviFlex? PusherJul 31, 2026Malfunction3005099803-2026-03113
- NaviFlex? PusherJul 31, 2026Malfunction3005099803-2026-03112
- Hurricane RXJul 31, 2026Malfunction3005099803-2026-03105
- CRE PROJul 31, 2026Malfunction3005099803-2026-03121
- Advanix? BiliaryJul 30, 2026Injury3005099803-2026-03095
- Advanix? BiliaryJul 30, 2026Malfunction3005099803-2026-03099
- MUSTANG?Jul 30, 2026Malfunction2124215-2026-40229
- Advanix? Pancreatic StentJul 30, 2026Malfunction3005099803-2026-03103
Recalls
77 recall events for this product code
- Open, ClassifiedJul 1, 2026
Potential sterile breach of the pouches in which devices are packaged.
View FDA record ↗ - Open, ClassifiedJul 1, 2026
Potential sterile breach of the pouches in which devices are packaged.
View FDA record ↗ - Open, ClassifiedJul 1, 2026
Potential sterile breach of the pouches in which devices are packaged.
View FDA record ↗ - Open, ClassifiedJul 1, 2026
Potential sterile breach of the pouches in which devices are packaged.
View FDA record ↗ - Open, ClassifiedJul 1, 2026
Potential sterile breach of the pouches in which devices are packaged.
View FDA record ↗ - Open, ClassifiedJul 1, 2026
Potential sterile breach of the pouches in which devices are packaged.
View FDA record ↗ - Open, ClassifiedSep 23, 2025
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
View FDA record ↗ - TerminatedNov 25, 2019
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
View FDA record ↗ - TerminatedNov 25, 2019
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
View FDA record ↗ - TerminatedNov 25, 2019
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
View FDA record ↗
510(k) clearances
13 clearances for this product code
- K223469Jun 15, 2023
WallFlex Biliary RX Stent System
- K223592Dec 29, 2022
Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K203162Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
- K172520Oct 4, 2017
CRE RX Biliary Balloon Dilatation Catheter
- K171809Aug 9, 2017
Epic Biliary Endoscopic Stent System
- K162404Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
- K141597Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
- K133110Jul 2, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
- K133700May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
- K122072Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE