Dilator, Urethral
Gastroenterology, Urology · 21 CFR 876.5520
Recent MDR events
221 adverse event reports on file
- OPTILUME BASIC UROLOGICAL DILATION CATHETERFeb 5, 2026MalfunctionUrotronic, Inc.24267706
- UROMAX ULTRA KITOct 31, 2025MalfunctionBoston Scientific Corporation2124215-2025-78190
- UROMAX ULTRA KITOct 31, 2025MalfunctionBoston Scientific Corporation2124215-2025-78198
- UROMAX ULTRA KITOct 31, 2025MalfunctionBoston Scientific Corporation2124215-2025-78201
- UROMAX ULTRA KITOct 31, 2025MalfunctionBoston Scientific Corporation2124215-2025-78202
- UROMAX ULTRAOct 3, 2025MalfunctionBoston Scientific Corporation2124215-2025-69977
- AMPLATZ RENAL DILATOR SETJun 20, 2025MalfunctionCook Inc1820334-2025-00742
- BARD® UROLOGIST'S TRAYApr 2, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-02219
- OPTILUMEMar 14, 2025InjuryLaborie Medical Technologies / Urotronic Inc.MW5167680
- AMPLATZ RENAL DILATOR SETJan 9, 2025MalfunctionCook Inc1820334-2025-00026
Event type breakdown
Recalls
3 recall events for this product code
- Cook Urological, Inc.TerminatedSep 24, 2005
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
Mislabeled as to size.
Z-1584-05 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Urethral Dilation Balloon Catheter with Open Tip
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Z-0970-2020 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Urethral Dilator Set, Global Product No. G14185
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Z-0971-2020 · View FDA record ↗
Registered firms
89 firms currently registered for this product code
Cook Incorporated
Bloomington, IN, US
Midwest Sterilization Corp.
JACKSON, MO, US
Sterigenics U.s., Llc
Atlanta, GA, US
Biomerics Fmi
Athens, TX, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Atrion Medical Products, Inc.
ARAB, AL, US
Cook Incorporated
ELLETTSVILLE, IN, US
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Cook Incorporated
Spencer, IN, US
Steritec Services, Llc
ATHENS, TX, US
Worldwide Supplies Limited
Hong Kong, HK
Argon Medical Devices Inc.
ATHENS, TX, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
C.r. Bard, Inc.
MADISON, GA, US
Cook Medical Llc
Bloomington, IN, US
Boston Scientific Corporation
Saint Paul, MN, US
C.r. Bard, Inc.
Queensbury, NY, US
B. Ali Impex
SIALKOT, Punjab, PK
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
QUINCY, MA, US
Sklar Corporation - Warehouse
Salisbury, MD, US
Ebner Medical Llc
Cincinnati, OH, US
510(k) clearances
27 clearances for this product code
- Urotronic, Inc.Jan 2, 2020
K191061 · Optilume Basic Urological Balloon Dilation Catheter
- Atrion Medical Products, Inc.Mar 3, 2004
K032840 · ATRION MEDICAL QL INFLATION DEVICE
- Atrion Medical Products, Inc.Oct 10, 1997
K972964 · ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
- Ryder Intl. Corp.Oct 21, 1996
K962611 · BARD EAGLE INFLATION DEVICE
- Cook Urological, Inc.Oct 18, 1996
K961904 · AQ HYDROPHILIC DILATORS
- U.S. Medical Corp.May 26, 1993
K924440 · U.S. MEDICAL PS-7000 DIALYSIS SCALE
- American Medical Systems, Inc.Oct 28, 1992
K920551 · 120 FR OPTILUME PROSTATE BALLOON DILATOR
- Boston Scientific CorpAug 14, 1992
K922349 · DOWD(TM) II