Bardia® Coude Olive Tip Urethral Foley Catheter 802520Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741039072), received between Nov 2, 2018 and Apr 4, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 2, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT INTERMITTENT CATHETERS CAUSED EXTREME DISCOMFORT AND BLEEDING FOR PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER ON 14JUN2024, IT WAS REPORTED THAT THE CATHETERS CAUSED EXTREME DISCOMFORT AND BLEEDING BECAUSE THE RUBBER IS VERY HARD AND OUTLET HOLES HAVE SHARP EDGES. CUSTOMER ALSO REPORTED THAT THE CATHETERS DON'T BEND VERY WELL. CUSTOMER HAS DECIDED TO DISCONTINUE USE OF THE CATHETERS AND IS USING A DIFFERENT PRODUCT. PER ADDITIONAL INFORMATION VIA CUSTOMER ON 05JUL2024, THERE WAS NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 19655507 ↗
• MalfunctionDec 27, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN USING THE INTERMITTENT CATHETERS SINCE THE 1980S AND THE PROBLEM WAS NOT NOTICED UNTIL APPROXIMATELY 1 1/2 ¿ 2 YEARS AGO. THEY CONTACTED THE COMPANY AND GOT JAILED AROUND FOR A YEAR ON (B)(6) 2022. THEY SENT A FEW CATHETERS USING THE PACKAGING MATERIAL THEY SENT TO THEM. THE ISSUE WAS THE TIPS OF THE CATHETERS WERE NOT THE SAME SIZE AND THEY SHOULD BE. PACKAGE SHOWED THE SIZE AND DESCRIPTION. THE TIPS WERE DIFFERENT AS IT AFFECTED THEIR RESULTS DURING USAGE. IF THE TIP WAS SMALLER THEY WERE SUCCESSFUL AND IF IT¿S LAYER WAS FULLER THEY WERE NOT, WHICH A WASTE OF TIME, MONEY AND THEIR OVERALL WELLBEING. THEY CALLED AND WAS TOLD STILL BEING INVESTIGATED, A FEW MONTHS LATER, THEY GOT THE SAME COMMENT, THEN A FEW MONTHS LATER THEY WERE TOLD THE CASE WAS CLOSED, BUT, WOULD REOPEN A NEW CASE. ON 24OCT2023, THEY GOT AN EMAIL MENTIONING THEIR COMPLAINT BUT THEIR CONCLUSION WAS THE CATHETER WAS NOT WASTED. IT WAS LIKE THEY DID NOT INVESTIGATE THE ACTUAL PROBLEM. ALSO STATED THAT THE CUSTOMER WAS HAVING OVER 30 YEARS EXPERIENCE USING THIS CATHETERS AND KNEW THE TIPS WERE NOT ALL THE SAME, LIKE THEY NOTED PREVIOUSLY, THE TIPS SHOULD ALL BE SMALLER. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400597 ↗
• MalfunctionJul 11, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT TIPS OF THE INTERMITTENT CATHETERS WERE NOT THE SAME SIZE. SMALL AND LARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298312 ↗
• MalfunctionMay 24, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING CATHETERS AND HAVING PROBLEMS SINCE LAST YEAR, TIP OF CATHETER VARY IN SIZE, THE SKINNY TIP WAS SUCCESSFUL, THE BIGGER TIP DID NOT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992815 ↗
• MalfunctionOct 21, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE INTERMITTENT CATHETERS SINCE 1980 AND NOTICED AN ISSUE ON AND OFF FOR YEARS. CUSTOMER STATED THAT THE ISSUE WAS IT SEEMED ALL THE RED RUBBER INTERMITTENT CATHETERS WERE NOT THE SAME SIZE ALTHOUGH IT STATED IT WAS ON THE PACKAGE AND HOW THEY KNEW WAS THAT THE TIPS WERE OBVIOUSLY DIFFERENT IN SIZE AND IT AFFECTED THE RESULTS DURING USAGE. STATED THAT IF THE TIP WAS SMALLER THE CUSTOMER WAS SUCCESSFUL AND IF IT WAS LARGER OR FULLER THE CUSTOMER WAS NOT. PER CUSTOMER VIA EMAIL ON 24AUG2022, IT WAS STATED THAT IN A PACKAGE OF 15 INTERMITTENT CATHETERS, THE MAJORITY OF THE CATHETERS WERE TOO BIG. THE CUSTOMER PROVIDED TWO LOT NUMBERS (BATCH# NGGN0626 MATERIAL# 802520 ; BATCH# NGEP1662 MATERIAL# 802520). THE CUSTOMER STATED THAT THIS HAD BEEN GOING ON FOR A FEW YEARS. PER INVESTIGATOR NOTIFICATION ON 12OCT2022, IT WAS REPORTED THAT AN UNOPENED INTERMITTENT CATHETER SENT FOR SAMPLE EVALUATION WAS NOTED TO BE TWISTED WHEN RETURNED PER NOTIFICATION FROM INVESTIGATOR BASED ON SAMPLE EVALUATION ON 09FEB2023, IT WAS FOUND THAT THE STICKY RESIDUE WAS PRESENT ON THE SURFACE OF THE INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649865 ↗
• MalfunctionSep 2, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE INTERMITTENT CATHETERS SINCE 1980 AND NOTICED AN ISSUE ON AND OFF FOR YEARS. CUSTOMER STATED THAT THE ISSUE WAS IT SEEMED ALL THE RED RUBBER INTERMITTENT CATHETERS WERE NOT THE SAME SIZE ALTHOUGH IT STATED IT WAS ON THE PACKAGE AND HOW THEY KNEW WAS THAT THE TIPS WERE OBVIOUSLY DIFFERENT IN SIZE AND IT AFFECTED THE RESULTS DURING USAGE. STATED THAT IF THE TIP WAS SMALLER THE CUSTOMER WAS SUCCESSFUL AND IF IT WAS LARGER OR FULLER THE CUSTOMER WAS NOT. PER CUSTOMER VIA EMAIL ON 24-AUG-2022, IT WAS STATED THAT IN A PACKAGE OF 15 INTERMITTENT CATHETERS, THE MAJORITY OF THE CATHETERS WERE TOO BIG. THE CUSTOMER PROVIDED TWO LOT NUMBERS. THE CUSTOMER STATED THAT THIS HAD BEEN GOING ON FOR A FEW YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347467 ↗
• MalfunctionAug 22, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE INTERMITTENT CATHETERS SINCE 1980 AND NOTICED AN ISSUE ON AND OFF FOR YEARS. THE CUSTOMER STATED THAT THE ISSUE WAS WITH THE CATHETER SIZE, IT SEEMED ALL THE INTERMITTENT CATHETERS WERE NOT THE SAME SIZE, EVEN THOUGH THE SIZE MENTIONED IN THE PACKAGE WAS THE SAME. DURING THE USAGE, THE CUSTOMER FOUND THAT THE TIPS WERE OBVIOUSLY DIFFERENT IN SIZE, WHICH AFFECTED THE RESULTS. IT WAS ALSO STATED THAT IF THE TIP WAS SMALLER THE CUSTOMER WAS SUCCESSFUL AND IF IT WAS LARGER OR FULLER THE CUSTOMER WAS NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265017 ↗
• InjuryOct 21, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION THAT WAS CAUSED BY THE CATHETERS AND PATIENT FINISHED THE TREATMENT OF ANTIBIOTICS. PER FOLLOW UP VIA PHONE ON 09OCT2020, PATIENT EXPERIENCED THE INFECTION (PSEUDOMONAS AND MORGANELLA) BY USING THE CATHETER.

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

  MAUDE report 10712540 ↗
• InjuryMay 1, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A BLADDER INFECTION BY HIS PHYSICIAN AFTER USING THE RED RUBBER CATHETER. THE TREATMENT PROVIDED IS UNKNOWN.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 8567964 ↗
• MalfunctionJan 3, 2019Misassembled; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE RED RUBBER COUDE CATHETER APPEARED TO HAVE PART OF ANOTHER CATHETER FUSED TO IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8212294 ↗
• MalfunctionNov 29, 2018Nonstandard Device; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT THE COUDE CATHETER APPEARED DEFORMED AND WAS CURVED OVER MORE THAN NORMAL. THE PATIENT EXPERIENCED SELF LIMITED BLEEDING DURING INSERTION AND WAS NOT ABLE TO CONTINUE USE OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8118469 ↗
• MalfunctionNov 2, 2018Misassembled; Misassembled; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CATHETER DID NOT HAVE ANY EYELETS PUNCHED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8033289 ↗