Bardia® Urethral Catheter 802416Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741018367), received between Nov 29, 2017 and Nov 29, 2021 — classified as 6 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Misassembled” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT OCCASIONALLY THERE WAS ONE RED RUBBER INTERMITTENT CATHETER THAT HAD SMALLER DIAMETER, SOFTER AND MORE FLEXIBLE AND WERE HENCE NOT USABLE FOR THE CUSTOMER AS THE RIGIDITY NEEDED WAS NOT THAT OF THE USUAL SIZE. IN THE PAST FEW MONTHS, CUSTOMER NOTED THAT THE NUMBER OF THESE DIFFERENT CATHETERS WERE ON THE RISE. CUSTOMER STATED THAT 9 CATHETERS WERE FOUND IN A BOX OF 100. CUSTOMER ALSO STATED THAT THE DIFFERENCE WAS CLEAR BOTH TO VISUAL INSPECTION AND TO FEEL. PER FOLLOW UP ON (B)(6) 2021, CUSTOMER HAD OCCASIONAL THIN-WALLED, SMALLER DIAMETER ONE IN A BOX OF 100. THE CURRENT BOX OF 100 THAT THE CUSTOMER WAS ABOUT TO FINISH HAD 38 OF THE THINNER ONES IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885551 ↗
• MalfunctionApr 26, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT SOME OF THE CATHETERS WERE OF DIFFERENT SIZE FROM THE OTHERS. PER INVESTIGATOR NOTIFICATION ON 02APR2021 DURING EVALUATION, IT WAS FOUND THAT THE CATHETER WAS FOUND TO BE HAVING INCORRECT FRENCH SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724423 ↗
• MalfunctionJan 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO USE THE REST OF THE URETHRAL CATHETER FROM HIS LAST ORDER AND NEEDED THE COUDE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11132144 ↗
• MalfunctionDec 29, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT SOME CATHETERS WERE IN DIFFERENT SIZES FROM THE OTHERS. PER INVESTIGATOR NOTIFICATION RECEIVED ON 02APR2021 DURING EVALUATION IT WAS FOUND THAT THE CATHETER WITH CORPORATE LOT NUMBER (NGDV0112) WAS FOUND TO BE THE INCORRECT FRENCH SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11089091 ↗
• MalfunctionDec 17, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT SOME CATHETERS WERE THIN AND FLEXIBLE. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO USE THEM AND THROWN THE CATHETERS AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11032150 ↗
• InjuryDec 11, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION AND WENT THE A WALK-IN CLINIC WHERE THEY PRESCRIBED ANTIBIOTICS. PATIENT STATED THE URINARY TRACT INFECTION WAS FROM USING THE CATHETERS AND LUBRICANT PACKETS. ALSO STATED THAT THE DOCTOR ¿EXPLICITLY SAID THIS WAS CATHETER RELATED.¿ PATIENT SAID DOCTOR ADVISED TO USE PRE-LUBRICATED CATHETERS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Urinary Tract Infection

  MAUDE report 10992687 ↗
• MalfunctionSep 1, 2020Component Missing; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PACKAGE WAS HARD TO OPEN AND SOME TIMES CAUSED A MESS AND THE PATIENT RECEIVED PACKAGE WITH NO CATHETER INSIDE.

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

  MAUDE report 10480321 ↗
• MalfunctionJun 15, 2020Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT POWDER WAS FOUND INSIDE THE CATHETER OF TWO BOXES. THE PATIENT DID NOT WANT TO PUSH THAT POWDER INTO THE BLADDER WHILE IRRIGATING.

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

  MAUDE report 10155090 ↗
• MalfunctionMay 12, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID HE¿S BEEN BLEEDING FOR A WHILE NOW; WHILE THE CATHETERS WERE NOT BLAMED, THE PATIENT SAID HE DID SEE A DOCTOR FOR THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10046453 ↗
• InjuryMar 20, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UTI, BUT THE SYMPTOMS HAVE RESOLVED. HE WAS UNSURE IF THE UTI WAS FROM THE CATHETERS OR NOT. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9862633 ↗
• MalfunctionFeb 6, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT SAID THE RED RUBBER CATHETERS WERE TOO FLIMSY. PER ADDITIONAL INFORMATION ON 16JAN2020, THE CUSTOMER STATED THAT HE WAS UNABLE TO INSERT AND VOID WITH THE CATHETERS. HE STATED THAT HE HAD INTERNAL ISSUES, AND THAT IS WHY HE WAS NOT ABLE TO USE THE DEVICE. HE REQUESTED TO TRY ANOTHER DEVICE.

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

  MAUDE report 9676340 ↗
• MalfunctionNov 13, 2019Misassembled; Misassembled; Component Missing

  IT WAS REPORTED THAT THREE OF THE CATHETERS HAD NO EYELETS.

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

  MAUDE report 9315758 ↗
• MalfunctionOct 15, 2019Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT STATED HE HAD TROUBLE INSERTING THE CATHETER WITH THE LUBE PACKET. THE PATIENT WANTED TO TRY HYDROPHILIC CATHETERS.

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

  MAUDE report 9194273 ↗
• MalfunctionJul 22, 2019Misassembled; Misassembled; Defective Device

  IT WAS REPORTED THAT DURING EVALUATION OF THE SAMPLE RECEIVED, IT WAS NOTED THAT THE DRAINAGE EYES ON THE URETHRAL CATHETER WERE TOO CLOSE TO THE TIP.

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

  MAUDE report 8813086 ↗
• MalfunctionJul 22, 2019Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INSERT THE CATHETER AND EXPERIENCED CONSIDERABLE PAIN AND BLEEDING. THE PATIENT WAS REPORTEDLY TAKEN TO THE EMERGENCY ROOM; TREATMENT PROVIDED IS UNKNOWN. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT ON JUL 26 2019, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM TO HAVE A NEW CATHETER INSERTED. THERE WAS NO MEDICAL INTERVENTION PERFORMED.

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

  MAUDE report 8811533 ↗
• MalfunctionMay 15, 2019Misassembled; Material Deformation; Misassembled

  IT WAS REPORTED THAT THE EYELETS OF THE CATHETERS WERE TOO FAR FORWARD; THE PATIENT WAS NOT ABLE TO USE THEM. IT WAS ALSO NOTED THAT THE CATHETERS SEEM TO BE REFURBISHED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8612150 ↗
• MalfunctionApr 29, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE DRAINAGE EYE ON THE URETHRAL CATHETER APPEARS TO BE SMALLER THAN USUAL.

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

  MAUDE report 8562347 ↗
• MalfunctionApr 23, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BARDIA URETHRAL CATHETER HAD A SHARP SURFACE AROUND THE DRAINAGE EYES. THE PATIENT EXPERIENCED PAIN, CUTS, AND HEMATURIA WHILE USING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion; Hematuria; Pain; Tissue Damage

  MAUDE report 8541989 ↗
• InjuryApr 23, 2019Flaked; Material Fragmentation; Flaked

  IT WAS REPORTED THAT THE RUBBER FROM THE TIP OF THE BARDIA URETHRAL CATHETER WAS FLAKING OFF WITHIN THE PATIENT. THE PATIENT REPORTED THAT THE RUBBER LEFT BEHIND CAUSED A URINARY TRACT INFECTION TO OCCUR. THE PATIENT WAS TREATED WITH CIPRO.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Urinary Tract Infection

  MAUDE report 8541704 ↗
• MalfunctionApr 23, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BEING CUT BY THE EYELETS OF THE CATHETER. THE PATIENT ALSO EXPERIENCED PAIN AND HEMATURIA. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion; Hematuria; Pain

  MAUDE report 8540110 ↗
• InjuryApr 23, 2019Flaked; Particulates; Flaked

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FOUR UTI'S (URINARY TRACT INFECTIONS). IT WAS UNKNOWN IF TREATMENT WAS RECEIVED FOR THE URINARY TRACT INFECTIONS. PER ADDITIONAL INFORMATION RECEIVED, THERE WERE PIECES OF THE CATHETER IN THE PATIENT'S URINE AND DUE TO THIS PROBLEM HE HAS BEEN HAVING URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8539805 ↗
• MalfunctionMar 1, 2019Misassembled; Inadequacy of Device Shape and/or Size; Infusion or Flow Problem; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYE ON THE URETHRAL CATHETER WAS TOO SMALL AND ALLEGEDLY CAUSED THE URINE TO DRAIN MORE SLOWLY. THE COMPLAINANT ALLEGED THAT THE CHANGES IN THE TEMPERATURE AFFECTED THE SIZE OF THE DRAINAGE EYES.

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

  MAUDE report 8383538 ↗
• MalfunctionFeb 15, 2019Break; Misassembled; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYE ON THE URETHRAL CATHETER WAS TOO SMALL PREVENTING THE PROPER DRAINAGE OF URINE. THE COMPLAINANT NOTED THAT IT TOOK 30 MINUTES TO DRAIN THE BLADDER.

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

  MAUDE report 8342782 ↗
• MalfunctionOct 10, 2018Misassembled; Misassembled; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO COLLECT URINE AS THE EYELETS WERE TO CLOSE TO THE TIP OF THE CATHETER.

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

  MAUDE report 7953748 ↗
• MalfunctionSep 10, 2018Break; Component Missing; Break

  IT WAS REPORTED THAT THE PATIENT FOUND THE TIP OF THE CATHETER MISSING UPON REMOVAL. THE PATIENT COULD NOT VERIFY IF THE TIP OF THE CATHETER WAS PRESENT BEFORE INSERTION. THERE HAS BEEN NO MEDICAL INTERVENTION.

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

  MAUDE report 7862063 ↗