Stent, Ureteral
Gastroenterology, Urology · 21 CFR 876.4620
Recent MDR events
5,858 adverse event reports on file
- Polaris? UltraJul 31, 2026MalfunctionBoston Scientific Corporation2124215-2026-41291
- Bard® InLay Optima® Ureteral Stent with HydroGlide¿ GuidewireJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05009
- Polaris? LoopJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40523
- SOF-FLEX MULTI-LENGTH URETERAL STENT SETJul 29, 2026MalfunctionCook Inc1820334-2026-00771
- SOF-FLEX MULTI-LENGTH URETERAL STENT SETJul 29, 2026MalfunctionCook Inc1820334-2026-00772
- ContourJul 28, 2026MalfunctionBoston Scientific Corporation2124215-2026-40215
- Tumor Stent double loop ureteral stent kitJul 27, 2026InjuryColoplast A/s9610711-2026-00221
- Tumor Stent double loop ureteral stent kitJul 27, 2026InjuryColoplast A/s9610711-2026-00222
- SOF-FLEX MULTI-LENGTH URETERAL STENT SETJul 27, 2026InjuryCook Inc1820334-2026-00750
- PERCUFLEXJul 22, 2026InjuryBoston Scientific Corporation2124215-2026-39490
Event type breakdown
Recalls
55 recall events for this product code
- C.R. Bard IncOpen, ClassifiedDec 11, 2025
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0905-2026 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedDec 11, 2025
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0906-2026 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedDec 11, 2025
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0907-2026 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedDec 11, 2025
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0908-2026 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Biliary Pigtail Stent Kits (containing 3412)
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0037-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Biliary Pigtail Stent Kits (containing 3412)
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0038-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Biliary Pigtail Stent Kits (containing 6105)
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0039-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Biliary Pigtail Stent Kits (containing 3412)
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0040-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Biliary Pigtail Stent Kits (contains 3412)
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0041-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Biliary Pigtail Stent Kits (containing 3412)
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0042-2023 · View FDA record ↗
Registered firms
231 firms currently registered for this product code
Boston Scientific Corporation
Coventry, RI, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Isomedix Operations Inc.
Northborough, MA, US
Applied Medical Distribution Center
Irvine, CA, US
Cook Incorporated
ELLETTSVILLE, IN, US
Cook Incorporated
Spencer, IN, US
Boston Scientific Corporation
El Coyol Alajuela, CR
Boston Scientific Corporation
La Aurora Heredia, CR
Boston Scientific Corporation
Saint Paul, MN, US
Alton Shanghai Medical Instruments Co Ltd
Shanghai, CN
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Cook Medical Eudc Gmbh
Baesweiler North Rhine-Westphalia, DE
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Bq Plus Medical Co.,ltd
SONGJIANG Shanghai, CN
The Ureteral Stent Company, Inc.
Beachwood, OH, US
Cook Incorporated
Bloomington, IN, US
Gyrus Acmi, Inc.
Westborough, MA, US
Steritec Services, Llc
ATHENS, TX, US
Applied Medical Resources Corp.
RSM, CA, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
510(k) clearances
122 clearances for this product code
- Zhejiang Chuangxiang Medical Technology Co., Ltd.Feb 20, 2026
K251890 · Disposable Ureteral Stents
- Cathegenix (Xiamen) Co., Ltd.Dec 19, 2025
K251469 · Endura Ureteral Stent and Stent Set
- Alton (Shanghai) Medical Instruments Co., Ltd.Jun 18, 2025
K243039 · Ureteral Stents (AF-D series)
- Shenzhen Trious Medical Technology Co., Ltd.May 14, 2025
K243830 · Disposable ureteral stent
- Boston Scientific CorporationApr 15, 2025
K250824 · Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
- Ureteral Stent CompanyMar 22, 2024
K232920 · RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
- Boston Scientific CorporationNov 10, 2022
K211934 · APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
- Coloplast Corp.Jun 8, 2022
K213185 · ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits