Catheter, Coude
Gastroenterology, Urology · 21 CFR 876.5130
Recent MDR events
10,371 adverse event reports on file
- Bardex® Lubricath® Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05058
- Bardex® Lubricath® Foley Catheter Councill ModelJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05054
- Bardex® Lubricath® Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05067
- Bardia® Foley Catheter Silicone CoatedJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05069
- Bardex® Lubricath® Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05068
- Bardia® Foley Catheter Silicone CoatedJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05076
- Bardia® Foley Catheter Silicone CoatedJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05074
- Bardex® Lubricath® Foley Catheter Councill ModelJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05071
- Bardia® Foley Catheter Silicone CoatedJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05070
- Bardex® Foley Catheter Silicone CoatedJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05079
Event type breakdown
Most-reported manufacturers
Recalls
10 recall events for this product code
- C.R. Bard IncOpen, ClassifiedJul 3, 2025
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Cather packaging may contain the incorrect French size.
Z-2076-2025 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
Z-2529-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
Z-2530-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
Z-2531-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
Z-2532-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2534-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
There is potential for packaging defects that may impact the sterile barrier.
Z-2535-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2536-2021 · View FDA record ↗ - C.R. Bard, Inc., Urological DivisionTerminatedSep 7, 2012
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use.
Incomplete seal on sterile packages of product.
Z-2327-2012 · View FDA record ↗ - C.R. Bard, Inc.TerminatedUnknown
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Foley Catheter with Incorrect Retainer Cap Print
Z-2064-2018 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Bard Sdn. Bhd.
KULIM Kedah, MY
C.r. Bard, Inc.
MADISON, GA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Bard Shannon Limited
Humacao, PR, US
Compactcath, Inc
Palo Alto, CA, US
Wellspect Medikal A.s.
Kahramankazan Ankara, TR
Km Medical
North York Ontario, CA
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Urogen Pharma Ltd.
Ra'anana Central, IL
Innovative Medical Manufacturing Co.
Zhunan Township, Miaoli County, TW
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Productos Para El Cuidado De La Salud
NOGALES Sonora, MX
Med Pro Medical B.v
Veenendaal Utrecht, NL
Wellspect Healthcare
Molndal Vastra Gotaland, SE
Teleflex Medical Sdn. Bhd.
KAMUNTING Perak, MY
Jiangsu Suyun Medical Materials Co., Ltd.
Lianyungang Jiangsu, CN
Atom Health Corporation
Tainan City, TW
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
510(k) clearances
7 clearances for this product code
- Teleflex MedicalAug 29, 2022
K222279 · Rusch Intermittent Urethral Catheters
- Teleflex MedicalJan 29, 2018
K173596 · Rusch Intermittent Urethral Catheters
- Louisville Laboratories, Inc.Mar 31, 1995
K946282 · UNIVERSAL URETHRAL CATHETER
- C.R. Bard, Inc.Jan 27, 1992
K913341 · BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
- C.R. Bard, Inc.Aug 16, 1991
K910846 · BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
- C.R. Bard, Inc.Aug 9, 1991
K910197 · HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
- C.R. Bard, Inc.Aug 9, 1991
K910195 · BARD HYDROGEL-COATED FOLEY CATHETERS