Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Gastroenterology, Urology · 21 CFR 876.5010
Recent MDR events
441 adverse event reports on file
- TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZINGJul 22, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00363
- FUSION QUATTRO EXTRACTION BALLOONJul 16, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00353
- FUSION EXTRACTION BALLOON WITH MULTIPLE SIZINGJul 6, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00322
- SPYGLASS DISCOVERJun 29, 2026InjuryBoston Scientific Corporation3005099803-2026-02611
- SPYGLASS DISCOVERMay 28, 2026InjuryBoston Scientific Corporation3005099803-2026-02176
- FUSION QUATTRO EXTRACTION BALLOONMay 21, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00244
- FUSION EXTRACTION BALLOON WITH MULTIPLE SIZINGMay 11, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00223
- FUSION EXTRACTION BALLOON WITH MULTIPLE SIZINGApr 9, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00169
- FUSION QUATTRO EXTRACTION BALLOONMar 26, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00144
- FUSION EXTRACTION BALLOON WITH MULTIPLE SIZINGMar 24, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00139
Event type breakdown
Recalls
2 recall events for this product code
- EXP Pharmaceutical Services CorpTerminatedJul 24, 2015
Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm;
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Z-2245-2015 · View FDA record ↗ - Wilson-Cook Medical IncTerminatedOct 24, 2003
Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wi
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Z-0068-04 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Becton, Dickinson And Company
Irvine, CA, US
Synergy Health Ast, Srl
Alajuela, CR
Teleflex Llc (nadc)
Olive Branch, MS, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Applied Medical Resources Corp.
RSM, CA, US
Conmed Corporation
Utica, NY, US
Wilson-cook Medical Inc.
Winston Salem, NC, US
Jiangsu Vedkang Medical Science And Technology Co.,ltd.
Changzhou Jiangsu, CN
Teleflex Medical Llc
Morrisville, NC, US
Hangzhou Ags Medtech Co., Ltd.
Hangzhou Zhejiang, CN
Platinum Focus Group Ltd.
London London, City of, GB
Cook Incorporated
ELLETTSVILLE, IN, US
Boston Scientific Medical Device (malaysia) Sdn Bhd
Taman Perindustrian Batu Kawan Pulau Pinang, MY
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Edwards Lifesciences Technology Sarl
ANASCO, PR, US
Cbr Enterprise Limited
Hong Kong, HK
Sterigenics U.s., Llc
Queensbury, NY, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Applied Medical Distribution Center
Irvine, CA, US
510(k) clearances
26 clearances for this product code
- Zhejiang Soudon Medical Technology Co., Ltd.May 8, 2026
K253013 · Disposable Stone Retrieval Balloon Catheter
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.Feb 26, 2024
K232752 · Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- Boston Scientific CorporationMay 6, 2022
K212582 · SpyGlass Discover Balloon Dilation Catheter
- Anrei Medical (Hangzhou) Co., Ltd.Apr 27, 2021
K210660 · Stone Retrieval Balloon Catheter
- Hangzhou AGS MedTech Co., Ltd.May 1, 2020
K200173 · Stone Retrieval Balloon
- Wilson-Cook Medical, Inc.Feb 27, 2020
K200247 · Fusion Quattro Extraction Balloon
- Wilson-Cook Medical, Inc.Dec 13, 2019
K193344 · Tri-Ex Extraction Balloon with Multiple Sizing
- Wilson-Cook Medical, Inc.Jul 6, 2018
K173659 · Howell D.A.S.H Extraction Balloon with Multiple Sizing