Catheter, Urological
Gastroenterology, Urology · 21 CFR 876.5130
Recent MDR events
17,035 adverse event reports on file
- Bardex® Foley Catheter Silicone CoatedJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05077
- Bardex® Silicone Coated Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05078
- Bardia® Foley Catheter Silicone CoatedJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04999
- Bardex® Foley Catheter Silicone CoatedJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05000
- SureStep Intermittent Catheter TrayJul 29, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04988
- Bardex® Lubricath® Foley CatheterJul 29, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04996
- GENTLECATHJul 28, 2026MalfunctionUnomedical S.r.o.3005778470-2026-00789
- GENTLECATHJul 28, 2026MalfunctionUnomedical S.r.o.3005778470-2026-00790
- Bardex® Foley Catheter Silicone CoatedJul 28, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04975
- Bard® Rubber Utility CatheterJul 28, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04972
Event type breakdown
Recalls
107 recall events for this product code
- C.R. Bard IncOpen, ClassifiedJul 3, 2025
BD Heyman Follower Straight Tip for following sizes:
Cather packaging may contain the incorrect French size.
Z-2074-2025 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedJul 3, 2025
BD Heyman Follower Coude Tip for following sizes:
Cather packaging may contain the incorrect French size.
Z-2075-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedFeb 16, 2024
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY,
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1052-2024 · View FDA record ↗ - TELEFLEX LLCOpen, ClassifiedNov 11, 2022
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Product may not be sterile
Z-0227-2023 · View FDA record ↗ - C.R. Bard, Inc.TerminatedSep 3, 2015
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and pa
Potential breach of the sterile barrier packaging.
Z-2732-2015 · View FDA record ↗ - C.R. Bard, Inc.TerminatedAug 14, 2015
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610.
Potential breach of the sterile barrier packaging.
Z-2384-2015 · View FDA record ↗ - C.R. Bard, Inc.TerminatedAug 14, 2015
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612.
Potential breach of the sterile barrier packaging.
Z-2385-2015 · View FDA record ↗ - C.R. Bard, Inc.TerminatedAug 14, 2015
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614.
Potential breach of the sterile barrier packaging.
Z-2386-2015 · View FDA record ↗ - C.R. Bard, Inc.TerminatedAug 14, 2015
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616.
Potential breach of the sterile barrier packaging.
Z-2387-2015 · View FDA record ↗ - C.R. Bard, Inc.TerminatedAug 14, 2015
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S.
Potential breach of the sterile barrier packaging.
Z-2388-2015 · View FDA record ↗
Registered firms
309 firms currently registered for this product code
Boston Scientific Corporation
SPENCER, IN, US
Sterigenics U.s., Llc
Santa Teresa, NM, US
Isomedix Operations Inc.
Northborough, MA, US
Terumo Corp.
SHIBUYA-KU, TOKYO, JP
Khtp Sterilisation Services Sdn. Bhd.
Kulim Hi Tech Park Kedah, MY
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Cardinal Health Singapore 225 Pte Ltd
SINGAPORE Central Singapore, SG
Mediquip Sdn. Bhd.
Kangar Perlis, MY
Teleflex Medical Sdn. Bhd.
KAMUNTING Perak, MY
Synergy Health Ede Bv
Venlo Limburg, NL
Unomedical S.r.o.
MICHALOVCE Kosicky, SK
Synergy Health Ast, Srl
Alajuela, CR
C.r. Bard, Inc.
COVINGTON, GA, US
C.r. Bard, Inc.
MADISON, GA, US
Rhenus Se & Co. Kg
Holzwickede North Rhine-Westphalia, DE
Hr Pharmaceuticals, Inc D/b/a Hr Healthcare
York, PA, US
Cook Incorporated
Spencer, IN, US
Sterigenics U.s., Llc
Ontario, CA, US
Bard Sdn. Bhd.
KULIM Kedah, MY
Nurse Assist, Llc
Haltom City, TX, US
Cook Incorporated
Bloomington, IN, US
Fortune Medical Instrument Corp.
Taoyuan City, TW
Isomedix Operations, Inc.
Minneapolis, MN, US
Degania Silicone, Ltd.
DEGANIA BET Northern, IL
510(k) clearances
238 clearances for this product code
- C.R. Bard, Inc.Feb 23, 2026
K251864 · Rubber Utility Catheter
- Well Lead Medical Co., Ltd.Dec 16, 2022
K220036 · Wellead Ureteral Catheter
- Allwin Medical Devices, Inc.Oct 13, 2022
K220730 · allFlex Ureteral Catheters, Krait Ureteral Catheters
- Urogen Pharma, Ltd.Nov 19, 2021
K211032 · Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
- Teleflexmedical, Inc.May 24, 2019
K181979 · Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
- Urogen Pharma, Ltd.Oct 30, 2018
K180354 · UroGen Ureteral Catheter
- Cook IncorporatedJun 28, 2018
K181144 · Angled Tip Ureteral Catheter
- Boston Scientific CorporationApr 10, 2018
K180530 · Imager II Urology Torque Catheter