Bardia Coude Olive Tip Urethral Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 380
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 6 models of Bardia Coude Olive Tip Urethral Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 380 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2017 and Sep 14, 2026 — classified as 27 injuries, 353 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (119 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 Bardia Coude Olive Tip Urethral Foley Catheter problems
Device problems
- Nonstandard Device119
- Difficult to Insert77
- Material Twisted/Bent73
- Component Misassembled43
- Incorrect Measurement34
- Misassembled24
- Material Deformation20
- Inadequacy of Device Shape and/or Size19
Patient problems
- No Clinical Signs, Symptoms or Conditions155
- No Known Impact Or Consequence To Patient114
- No Consequences Or Impact To Patient112
- No Patient Involvement32
- Pain26
- Discomfort24
- Urinary Tract Infection20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available17
Bardia Coude Olive Tip Urethral Foley Catheter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516CATHETER, UROLOGICAL170 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802514CATHETER, UROLOGICAL168 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802512CATHETER, UROLOGICAL23 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802520CATHETER, UROLOGICAL13 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802518CATHETER, UROLOGICAL5 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802522CATHETER, UROLOGICAL1 report
Recent Bardia Coude Olive Tip Urethral Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Tract Infection
MAUDE report 50764425 ↗MalfunctionSep 11, 2026Difficult to Insert
Patient problems: Insufficient Information
MAUDE report 50743267 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50634879 ↗MalfunctionApr 22, 2026Component Misassembled
IT WAS REPORTED THAT THE PATIENT STATED ONE BOX OF CATHETERS HAD NO HOLES AND COULD NOT BE USED. SHE MENTIONED THIS HAS HAPPENED ONCE BEFORE. OFFERED TO GET PATIENT TO CUSTOMER SERVICE FOR A REPLACEMENT BUT THE PATIENT DECLINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960241 ↗MalfunctionApr 14, 2026Component Misassembled
IT WAS REPORTED THAT THERE WAS A COUDE INTERMITTENT CATHETER THAT DIDN'T HAVE ANY EYELETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879369 ↗MalfunctionApr 9, 2026Material Fragmentation
IT WAS REPORTED BY CUSTOMER THAT PART OF THE TIPS OF SOME BARDA COUDE URETHRAL CATHETER UNITS HAD BEEN CUT OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829673 ↗MalfunctionApr 4, 2026Incorrect Measurement; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE CUSTOMER STATES THAT THEY ARE TOO SMALL ON THE TIP. PATIENT HAS ORDERED THIS PRODUCT PREVIOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784453 ↗MalfunctionFeb 27, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT THE EYELETS AND THE INTERMITTENT CATHETER THEMSELVES SEEM TO BE ROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475412 ↗MalfunctionFeb 18, 2026Partial Blockage
IT WAS REPORTED THAT PT SAID SOME HERE AND THERE HAVE A BLOCKAGE AND WON'T DRAIN. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379024 ↗MalfunctionNov 13, 2025Wrong Label; Wrong Label
IT WAS REPORTED THAT THE PATIENT SAID THEY WERE RECEIVING MANUFACTURER BOXES WITH COUDE INTERMITTENT CATHETER 802518 ON THEM BUT INSIDE ARE 802516.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544848 ↗MalfunctionAug 19, 2025Material Twisted/Bent; Material Twisted/Bent
PT STATED 1/4 OF THE 120 OF THE CATHETERS OF THE LAST TWO ORDERS THE DOT ON THE CATHETERS WERE TWISTED, NOT LINED UP. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22838447 ↗MalfunctionJul 7, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE REPORT RECEIVED INDICATING AN ISSUE WITH INTERMITTENT CATHETERS, PRODUCT CODE 802514. A BOX OF 100 CATHETERS WAS RECEIVED, AND WHILE MOST FUNCTION AS EXPECTED, OCCASIONAL UNITS APPEAR TO HAVE A LARGER OUTER DIAMETER THAN SPECIFIED. THE DISCREPANCY SUGGESTS SOME CATHETERS MAY BE 15 FRENCH (FR) INSTEAD OF THE INTENDED 14 FR, LEADING TO DISCOMFORT DURING USE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 11SEP2025, IT WAS REPORTED THAT CUSTOMER DOES NOT HAVE THE 'THICKER' ONES JUST NOW, BUT WOULD LIKE TO GET A BIOHAZARD BOX, AND SURELY SAVE A FEW OF THE ONES THAT CUSTOMER FEEL WAS NOT THE CORRECT SIZE WHEN GET TO USE IT. CUSTOMER HAD THIS ISSUE BEFORE AND SAYS IT JUST SEEMS LIKE THESE CATHETERS ARE NOT BEING CHECKED CAREFULLY ENOUGH DURING THE MANUFACTURING PROCESS. A GOOD "QC" CHECK (QUALITY CONTROL) WOULD SEEM PRUDENT GIVEN THE PERSONAL AND MEDICALLY NECESSARY USE OF THIS PRODUCT.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 22414058 ↗MalfunctionJul 7, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT SOME OF THE RED RUBBER CATHETERS WERE THICKER THAN NORMAL AND CAUSED DISCOMFORT DURING INSERTION DUE TO INCREASED THICKNESS. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER INFORMATION RECEIVED VIA MAIL ON (B)(6) 2025, IT WAS STATED THAT THE ONLY IMPACT FROM USING THE THICKER CATHETERS WAS THAT THEY WERE MORE DIFFICULT TO PASS THROUGH URETHRA. NO MEDICAL INTERVENTION WAS NECESSARY, BUT IT JUST MAKES FOR AN UNCOMFORTABLE PROCESS. CUSTOMER HAD THIS ISSUE BEFORE AND STATED THAT IT JUST SEEMS LIKE THESE CATHETERS WERE NOT BEING CHECKED CAREFULLY ENOUGH DURING THE MANUFACTURING PROCESS. A GOOD "QC" CHECK (QUALITY CONTROL) WOULD SEEM PRUDENT GIVEN THE PERSONAL AND MEDICALLY NECESSARY USE OF THIS PRODUCT.
Patient problems: Discomfort
MAUDE report 22412799 ↗MalfunctionMay 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THERE WAS RAISED BUMPS ON THE SHAFT OF THE INTERMITTENT CATHETER. PATIENT EXPERIENCED PAIN. LOT#NGJY3625, LOT#NGJX1963, LOT#NGJX3142. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Pain
MAUDE report 22114105 ↗MalfunctionMay 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THERE WAS RAISED BUMPS ON THE SHAFT OF THE INTERMITTENT CATHETER. PATIENT EXPERIENCED PAIN. LOT #NGJY3625, LOT #NGJX1963, LOT #NGJX3142. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Pain
MAUDE report 22114076 ↗
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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