Bardia® Coude Olive Tip Urethral Foley Catheter 802514Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00801741039041), received between May 2, 2017 and Sep 11, 2026 — classified as 11 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (62 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Difficult to Insert

  Patient problems: Insufficient Information

  MAUDE report 50743267 ↗
• 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 ↗
• 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 ↗
• 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 14, 2025Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT SAID THAT THEY HAD 19 INTERMITTENT CATHETERS HAD BLACK SPECKS ON THEM. THEY DID NOT FEEL COMFORTABLE USING. THEY RECENTLY FOUND OUT THAT THEY WOULD BE HAD SURGERY SOON AND DID NOT WANT THEM REPLACED.

  Patient problems: Discomfort

  MAUDE report 22019807 ↗
• InjuryJan 10, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CUSTOMER HAD PARAPLEGIC THAT HAS BEEN USING THE RED RUBBER COUDE INTERMITTENT CATHETER PRODUCTS FOR DECADES ALSO HAD NEVER HAD AN ISSUE UNTIL RECENTLY THE BATCHES BEING PRODUCED WERE NOT SAFE FOR USE. THE CUSTOMER HAD INJURED THEIR URETHRA DUE TO THE NEW, POORLY MADE CATHETERS ON MULTIPLE OCCASIONS LEADING TO 'URINARY TRACT INFECTION AND OTHER ISSUE ALSO HAD BEEN FORCED TO USE OLDER VERSIONS OF THE CATHETER TO AVOID THESE ISSUES. THE CUSTOMER HAS BEEN USED (LOT #NGFQ4299) WAS AN EXAMPLE OF THE ORIGINAL GOOD PRODUCT WITH A PERFECTLY SMOOTH SURFACE, THESE SEEMED TO NO LONGER BE IN PRODUCTION AS THE PACKAGE INDICATES THEY WERE MADE IN MEXICO. ALSO (BATCH# #NGJN3051), AND (BATCH# NGJT0667), WERE EXAMPLES OF THE NEW BAD PRODUCT NOTICEABLY BRIGHTER IN COLOR (BATCH# NGJN3051, BATCH# NGJT0667), A BIT SOFTER LOWER QUALITY FEEL (BATCH# NGJN3051, BATCH# NGJT0667), WHICH HAS SOME VERY INCONSISTENT MANUFACTURING ERRORS CREATING A TEXTURED SURFACE AND WAS CAUSING ABRASIONS IN THE URETHRA (BATCH# NGJN3051, BATCH# NGJT0667). THEY WANTED TO BRING THIS TO YOUR ATTENTION BECAUSE PEOPLE WERE GETTING HURT. THE PACKAGING INDICATES IT WAS MADE IN MALAYSIA. THE TEXTURE WAS SO BAD

  Patient problems: Abrasion; Urinary Tract Infection

  MAUDE report 21123829 ↗
• InjuryJan 10, 2025Material Protrusion/Extrusion; Sharp Edges; Material Protrusion/Extrusion; Sharp Edges

  IT WAS REPORTED THAT THE CUSTOMER HAD PARAPLEGIC THAT HAS BEEN USING THE RED RUBBER COUDE INTERMITTENT CATHETER PRODUCTS FOR DECADES ALSO HAD NEVER HAD AN ISSUE UNTIL RECENTLY THE BATCHES BEING PRODUCED WERE NOT SAFE FOR USE. THE CUSTOMER HAD INJURED THEIR URETHRA DUE TO THE NEW, POORLY MADE CATHETERS ON MULTIPLE OCCASIONS LEADING TO URINARY TRACT INFECTION AND OTHER ISSUE ALSO HAD BEEN FORCED TO USE OLDER VERSIONS OF THE CATHETER TO AVOID THESE ISSUES. THE CUSTOMER HAS BEEN USED (LOT #NGFQ4299) WAS AN EXAMPLE OF THE ORIGINAL GOOD PRODUCT WITH A PERFECTLY SMOOTH SURFACE, THESE SEEMED TO NO LONGER BE IN PRODUCTION AS THE PACKAGE INDICATES THEY WERE MADE IN MEXICO. ALSO (BATCH# #NGJN3051) AND (BATCH# NGJT0667) WERE EXAMPLES OF THE NEW BAD PRODUCT NOTICEABLY BRIGHTER IN COLOR (BATCH# NGJN3051, BATCH# NGJT0667) A BIT SOFTER LOWER QUALITY FEEL (BATCH# NGJN3051, BATCH# NGJT0667), WHICH HAS SOME VERY INCONSISTENT MANUFACTURING ERRORS CREATING A TEXTURED SURFACE AND WAS CAUSING ABRASIONS IN THE URETHRA (BATCH# NGJN3051, BATCH# NGJT0667). THEY WANTED TO BRING THIS TO YOUR ATTENTION BECAUSE PEOPLE WERE GETTING HURT. THE PACKAGING INDICATES IT WAS MADE IN MALAYSIA. THE TEXTURE WAS SO BAD ON M

  Patient problems: Abrasion; Urinary Tract Infection

  MAUDE report 21123826 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD PARAPLEGIC THAT HAS BEEN USING THE RED RUBBER COUDE INTERMITTENT CATHETER PRODUCTS FOR DECADES ALSO HAD NEVER HAD AN ISSUE UNTIL RECENTLY THE BATCHES BEING PRODUCED WERE NOT SAFE FOR USE. THE CUSTOMER HAD INJURED THEIR URETHRA DUE TO THE NEW, POORLY MADE CATHETERS ON MULTIPLE OCCASIONS LEADING TO 'URINARY TRACT INFECTION AND OTHER ISSUE ALSO HAD BEEN FORCED TO USE OLDER VERSIONS OF THE CATHETER TO AVOID THESE ISSUES. THE CUSTOMER HAS BEEN USED (LOT #NGFQ4299) WAS AN EXAMPLE OF THE ORIGINAL GOOD PRODUCT WITH A PERFECTLY SMOOTH SURFACE, THESE SEEMED TO NO LONGER BE IN PRODUCTION AS THE PACKAGE INDICATES THEY WERE MADE IN MEXICO. ALSO (BATCH# #NGJN3051) AND (BATCH# NGJT0667) WERE EXAMPLES OF THE NEW BAD PRODUCT NOTICEABLY BRIGHTER IN COLOR (BATCH# NGJN3051, BATCH# NGJT0667) A BIT SOFTER LOWER QUALITY FEEL (BATCH# NGJN3051, BATCH# NGJT0667), WHICH HAS SOME VERY INCONSISTENT MANUFACTURING ERRORS CREATING A TEXTURED SURFACE AND WAS CAUSING ABRASIONS IN THE URETHRA (BATCH# NGJN3051, BATCH# NGJT0667). THEY WANTED TO BRING THIS TO YOUR ATTENTION BECAUSE PEOPLE WERE GETTING HURT. THE PACKAGING INDICATES IT WAS MADE IN MALAYSIA. THE TEXTURE WAS SO BAD ON

  Patient problems: Urinary Tract Infection

  MAUDE report 21103033 ↗
• MalfunctionSep 26, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED INTERMITTENT CATHETER IN WHICH THE EYELET WAS SMALLER THAN IT USED TO BE. CUSTOMER WAS ASKING IF THE PRODUCT MANUFACTURED IN MEXICO WAS DIFFERENT FROM THAT MADE IN MALAYSIA. CUSTOMER HAD TWO LOT NUMBERS FOR PCN# 802514 LOT# NGHU2158 PACKAGED IN MEXICO AND LOT NGHY2506 PACKAGED IN MALAYSIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310078 ↗
• MalfunctionAug 30, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT USED BARDIA RED RUBBER CATHETER 802514. PATIENT GOT A VARIATION IN COLOR OF THE SAME PRODUCT. ALSO, THE CATHETER TIP WAS POINTIER (SHARPER) AND UNCOMFORTABLE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 20106489 ↗
• MalfunctionJul 2, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE RECENT SHIPMENT OF BARDIA (802514) CATHETERS WERE DIFFERENT THAN THE PREVIOUS MONTH. PATIENT STATES LOT# NGHZ3091 HAD A DIFFERENT COLOR TO THEM, THEY WERE FIRMER AND NARROWER AT THE TIP CAUSING DISCOMFORT WHEN USED. REPRESENTATIVE STATED THAT MANUFACTURING TEMPORARILY MOVED TO ANOTHER LOCATION AS NOGALES WAS UPDATING THE PLANT. PER FOLLOW UP VIA PHONE ON 17JUL2024, IT WAS REPORTED THAT THE CUSTOMER NOTICED A DIFFERENCE IN THE CATHETERS THEY CURRENTLY HAD AND THE ONES THEY PREVIOUSLY HAD. THE OLD CATHETERS WERE DARKER RED AND SOFTER. THE CATHETERS NOW SEEMED TO HAVE A FIRMER MATERIAL AND WERE MUCH MORE ORANGE. THEY STATED THAT THEY WERE LUBRICATING BUT THE STIFFNESS FROM THE CATHETER SOMETIMES CAUSED BLOOD IN THEIR STOMA. NO MEDICAL INTERVENTION WAS REPORTED. THEY WERE GOING TO LOOK FOR AN OLDER CATHETER TO SEND IN WITH A NEW CATHETER TO COMPARE AND WOULD LIKE A RESULT LETTER. PER SAMPLE RECEIVED ON 03SEP2024, IT AS REPORTED THAT THE CUSTOMER RETURNED 1 URETHRAL CATHETER WITH MATERIAL # 802514 AND BATCH # NGJS0534 AND 1 URETHRAL CATHETER WITH MATERIAL # 802514 AND BATCH # NGHW1755.

  Patient problems: Discomfort

  MAUDE report 19656588 ↗
• MalfunctionJun 28, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THEY GOT TWO RETURNS OF INTERMITTENT CATHETERS ONE FOR 802516 AND ANOTHER FOR 802514. THE PATIENT WITH MATERIAL# 802514 SAID THE ENDS WERE TOO BIG ON THEIR SHIPMENT WITH LOT# NGGT5344. THE PATIENT WITH MATERIAL# 802516 SAID THAT THE CATHETER CAME TO THEM WERE SUPER THICK AND THEY SENT BACK CATHETER WITH LOT# NGGU0960, COMPARED TO WHAT THEY CURRENTLY HAVE IN THE SLOT LOT# NGHY2643. THE COLOR WAS NOTICEABLY DIFFERENT SO IT WAS POSSIBLE IT COULD BE A DIFFERENT FORM OF RUBBER. THE DARKER RED THEY SENT BACK HAD AN EXPIRATION OF 28FEB2027 AND THEY NOTICED THE EYELET WAS SMALLER ON THE DARKER ONE. THE ONES THEY CURRENTLY HAD WERE A LIGHTER RED WITH EXPIRATION OF 30APR2028 SO WHATEVER THEY RECEIVED WAS AN OLDER MANUFACTURE DATE, SO IT WAS POSSIBLE BARD HAD CHANGED SOMETHING AND AGAIN IT DID APPEAR THE EYELET HOLE WAS BIGGER ON THE LIGHTER COLOR. PER CUSTOMER VIA EMAIL RESPONSE ON 24JUN2024, IT WAS REPORTED THAT THE PRODUCT WAS USED ON A PATIENT AND THE DEFECT WAS ALSO NOTICED BEFORE USE. NO PATIENT HARM WAS REPORTED. IT WAS UNKNOWN WHETHER THE CATHETER AND EYELET DIMENSIONS WERE UNDER SPECIFICATION. THE MATERIAL WAS TOO THICK, AND RIGID COMPARED TO OTHER LOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632316 ↗
• MalfunctionJun 24, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT INTERMITTENT CATHETER EYELET WAS 2/3 THE SIZE OF THE REMAINING PRODUCTS OF THE SAME ITEM NUMBER. PATIENT STATED THAT THIS LARGER HOLE SCRAPED AT THEIR URETHRA AND CAUSED BLEEDING. THEY WERE UNCOMFORTABLE USING CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 19594769 ↗
• MalfunctionJun 11, 2024Nonstandard Device; Improper Chemical Reaction; Nonstandard Device; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS DIFFERENT AND OF POORER QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509367 ↗
• MalfunctionMay 30, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT USED BARD RED RUBBER CATHETER 010114 AND BARDIA RED RUBBER CATHETER 802514. PATIENT STATED THAT THE RECENT SHIPMENT OF BARDIA CATHETERS 802514 WERE DIFFERENT THAN THE PREVIOUS MONTH. PATIENT STATED LOT# NGJN3051 HAD A DIFFERENT COLOR TO THEM, THEY WERE FIRMER AND NARROWER AT THE TIP CAUSING DISCOMFORT WHEN USED. THE LOT ALSO HAD A DIFFERENT STAMP ON THEM AND ARE MADE IN MALAYSIA. THE PREVIOUS CATHETERS LOT # NGHW4232 WERE SOFTER. THEY PREFERRED THE RED RUBBER LATEX CATHETERS OVER SILICONE. PATIENT ALSO STATED THEY REUSED THEIR CATHETERS ALTHOUGH THEY WERE LABELED 'SINGLE USE ONLY'. REPRESENTATIVE STATED THAT THE MANUFACTURING WAS TEMPORARILY MOVED TO ANOTHER LOCATION AS NOGALES WAS UPDATING THE PLANT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19423820 ↗
• MalfunctionNov 14, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS GETTING SMALLER AND FLIMSIER AND WAS BUCKLING WHEN INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132066 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DOCTOR SWITCHED THE PATIENT FROM COUDE INTERMITTENT CATHETER TO FOLEY CATHETER DUE TO GETTING URINARY TRACT INFECTION. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 16068401 ↗
• MalfunctionSep 7, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH CLOGGING OF THE COUDE INTERMITTENT CATHETER. THE PATIENT SAW THEIR DOCTOR, THEY WERE SENDING A NEW SCRIPT, BUT THE PATIENT COULD NOT USE THOSE CATHETERS BUT COULD USE WHAT THEY USUALLY SEND THEM. THE PATIENT DID NOT KNOW WHAT DOCTOR WAS CHANGING IT TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370203 ↗
• MalfunctionMay 18, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT 212 OF THE INTERMITTENT CATHETERS WERE SHAPED DIFFERENT. CUSTOMER ADDED THAT THE TIPS WERE STRAIGHT AND SHAPED WEIRD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429663 ↗
• MalfunctionMay 18, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT 212 OF THE INTERMITTENT CATHETERS WERE SHAPED DIFFERENT. CUSTOMER ADDED THAT THE TIPS WERE STRAIGHT AND SHAPED WEIRD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428595 ↗
• MalfunctionFeb 16, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS STARTING TO HAVE DIFFICULTY INSERTING THE COUDE CATHETERS. LIBERATOR REPRESENTATIVE ADVISED PATIENT TO SPEAK WITH DOCTOR AS WE WOULD NEED A NEW RX FOR ANOTHER CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546802 ↗
• MalfunctionDec 7, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT GOT ABOUT TEN COUDE INTERMITTENT CATHETERS THAT WERE BRITTLE AND OLD. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. PER FOLLOW-UP INFO RECEIVED ON 06DEC2021, PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957459 ↗