Bardex Lubricath Hematuria Coude Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 5 models of Bardex Lubricath Hematuria Coude Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between May 15, 2018 and Mar 13, 2026 — classified as 12 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardex Lubricath Hematuria Coude Foley Catheter problems
Device problems
- Fluid/Blood Leak9
- Partial Blockage8
- Material Rupture4
- Patient Device Interaction Problem4
- Deflation Problem3
- Difficult to Remove3
- Component Misassembled2
- Inability to Irrigate2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Known Impact Or Consequence To Patient5
- Burning Sensation2
- Dysuria2
- Foreign Body In Patient2
- Inflammation2
Bardex Lubricath Hematuria Coude Foley Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Lubricath® Hematuria Coude Foley Catheter 2557H22CATHETER, UROLOGICAL14 reports
- Bardex® Lubricath® Hematuria Coude Foley Catheter 2556H22CATHETER, UROLOGICAL10 reports
- Bardex® Lubricath® Hematuria Coude Foley Catheter 2557H20CATHETER, UROLOGICAL9 reports
- Bardex® Lubricath® Hematuria Coude Foley Catheter 2557H24CATHETER, UROLOGICAL9 reports
- Bardex® Lubricath® Hematuria Coude Foley Catheter 2556H20CATHETER, UROLOGICAL3 reports
Recent Bardex Lubricath Hematuria Coude Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Material Rupture
IT WAS REPORTED THAT THERE WERE PATIENT HARM AND DEVICE BURST DURING SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24595649 ↗MalfunctionFeb 12, 2026Flaked
IT WAS REPORTED THAT WHEN THE CUSTOMER WENT TO USE THE FOLEY CATHETER THE INTERNAL LINING WAS SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327936 ↗InjuryNov 7, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED FROM THE UROLOGY SERVICE COORDINATOR THERE THAT (B)(6) MEDICAL CENTER. THEY WERE HOPING THEY COULD HELP THEM OUT. THEY WERE HAVING SOME ISSUES WITH THE LUBRICATH HEMATURIA FOLEY CATHETERS. THE 22F AND 24F (REF (B)(4)) WERE HAVING ISSUES WITH THE INFLOW PORT NOT WORKING PROPERLY AND THE BALLOON HAVING ISSUES WITH DEFLATING. THOSE ISSUES THAT LEAD TO RISKY CATHETER CHANGES AFTER A DELICATE PROCEDURE CAUSING EITHER ADDITIONAL BLEEDING AND/OR ADDITIONAL PROCEDURES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23497563 ↗InjuryNov 7, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED FROM THE UROLOGY SERVICE COORDINATOR THERE THAT (B)(6). THEY WERE HOPING THEY COULD HELP THEM OUT. THEY WERE HAVING SOME ISSUES WITH THE LUBRICATH HEMATURIA FOLEY CATHETERS. THE 22F AND 24F (REF 2557H22 AND 2557H24) WERE HAVING ISSUES WITH THE INFLOW PORT NOT WORKING PROPERLY AND THE BALLOON HAVING ISSUES WITH DEFLATING. THOSE ISSUES THAT LEAD TO RISKY CATHETER CHANGES AFTER A DELICATE PROCEDURE CAUSING EITHER ADDITIONAL BLEEDING AND/OR ADDITIONAL PROCEDURES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23497562 ↗MalfunctionJun 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT CUSTOMER CALLED THAT THEIR BARD FOLEY CATHETER HAD COME OUT. SHOWED ONLY A TUBE AND NOTHING MORE. A MOMENT AGO, THERE WAS A POP AND FLUID WAS FLOWING. TAKES THE BARD CATHETER AND TAKES IT OUT TO THE SINK AND CHECKS WITH COLLEAGUES. THEY CONCLUDE THAT IT HAD BROKEN. IT LOOKS LIKE A CRACK GONE THROUGH IT AND THEY COULD CLEARLY SAW THAT EVERYTHING HAD COME OUT AND NOTHING WAS LEFT IN THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06JUN2025, STATED THAT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320986 ↗MalfunctionMay 30, 2025Inability to Irrigate; Inability to Irrigate
IT WAS REPORTED THAT IN THE ONLINE SURVEY A NURSE STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY IRRIGATE THE PATIENT WHILE Y USING 2557H20 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY DUFOUR, 30/50ML, 20 FR. BECAUSE OF "PASSAGE RELATED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114084 ↗MalfunctionMay 15, 2025Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS, URINARY SYMPTOMS (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)) ASSOCIATED WITH THE DEVICE 2557H22 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY DUFOUR, 30/50ML, 22 FR. AND IT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED SEPTICAEMIA/UROSEPSIS/WOUND INFECTION, BUT WHEN ASKED TO SPECIFY IF THE COMPLICATION WAS DEVICE RELATED INDICATED URINE RETENTION COULD INCREASE CHANCE TO SPREAD INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028033 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (BLOCKAGE, URINARY SYMPTOMS (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)) ASSOCIATED WITH THE DEVICE 2557H22 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY DUFOUR, 30/50ML, 22 FR. AND IT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED SEPTICAEMIA/UROSEPSIS/WOUND INFECTION, BUT WHEN ASKED TO SPECIFY IF THE COMPLICATION WAS DEVICE RELATED INDICATED URINE RETENTION COULD INCREASE CHANCE TO SPREAD INFECTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Dysuria; Inflammation; Itching Sensation; Micturition Urgency; Sepsis; Skin Inflammation/ Irritation; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Retention
MAUDE report 22028027 ↗InjuryMay 2, 2025Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS ((LEAKAGE), BLOCKAGE, (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)) ASSOCIATED WITH THE DEVICE 1852H18 BARD 2-WAY COUVELAIRE HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 18 FR AND IT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION ("HAD TO REMOVE THE CATHETER AND REINSERT ANOTHER CATHETER") AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT.
Patient problems: Burning Sensation; Dysuria; Inflammation; Itching Sensation; Micturition Urgency; Skin Inflammation/ Irritation; Urinary Frequency / Polyuria
MAUDE report 21950248 ↗InjuryMay 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE CRITICAL CARE NURSE IN THE ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (EROSION / PRESSURE INJURY (CAMPI)) ASSOCIATED WITH THE DEVICE 1852H18 BARD 2-WAY COUVELAIRE HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 18 FR. AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT.
Patient problems: Erosion; Pressure Sore/Ulcer
MAUDE report 21950215 ↗MalfunctionMay 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CRITICAL CARE NURSE IN THE ONLINE SURVEY STATED THAT SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS PRODUCT (1856H22 BARD 2-WAY DUFOUR HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 22 FR.) FOR THE SPECIFIED DURATION OF USE BECAUSE OF "IT WAS LEAKING." PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23APR2025, STATED THAT THE ISSUE WAS WITH THE PATIENT BECAUSE NO MATTER THE SIZE OF THE CATHETER, THERE WILL STILL BE A BYPASS AND THE INTENDED REASON FOR USE WAS NOT ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950211 ↗MalfunctionOct 1, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT 2 OF THE RIBBED BALLOON FOLEY CATHETERS RUPTURED WHEN WATER WAS ENTERED. PER FOLLOW UP VIA EMAIL ON 26NOV2024, IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT OTHER THEN WASTED CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343825 ↗InjuryOct 10, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSTALLED ON (B)(6) 2023. ON (B)(6), IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. SEEN WITH THE DOCTOR WHO PUNCTURED THE BALLOON.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 17906635 ↗MalfunctionMay 13, 2022Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled
IT WAS REPORTED THAT THE IRRIGATION PORT OF THE FOLEY CATHETER BLEW UP THE BALLOON AND THE INFLATION PORT IRRIGATED THE BLADDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397899 ↗MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED HEMATURIA AND LEAKAGE WHEN ASKED IF THEY EXPERIENCED COMPLICATIONS USING THE HYDROGEL COATED PROSTATIC CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14135357 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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