Bardia® Urethral Catheter 802414Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00801741018350), received between Sep 5, 2017 and Nov 8, 2021 — classified as 19 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (11 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT HAD DIFFICULTY TO INSERT THE CATHETER. FOLLOW UP VIA PHONE ON 24MAR2021, THE CUSTOMER NOTED THAT THE END OF THE CATHETER WAS VERY FLOPPY BECAUSE THE HOLES ARE OPPOSITE EACH OTHER SO, IT KEPT BENDING DURING INSERTION. WHICH MADE IT PAINFUL AND DIFFICULT TO INSERT THE FIRST 3 INCHES OF THE CATHETER. THE CUSTOMER WAS STILL ABLE TO INSERT THE CATHETER AND VOID THE BLADDER. THE CUSTOMER ADDED THAT THE MATERIAL ON THE CATHETER WAS NOT SMOOTH AND WAS A LITTLE ROUGH. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12769963 ↗
• MalfunctionJun 9, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD A PROTRUSION ABOUT 6 INCHES FROM THE EXIT WHILE USING IT. NO INJURY WAS REPORTED, JUST A CONCERN AS IT ALMOST REACHED THE PATIENT'S URETHRA. PER FOLLOW UP VIA PHONE (B)(6). 2021, CUSTOMER STATED THAT THE PROTRUSION WAS ONLY ABOUT A MILLIMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971582 ↗
• MalfunctionJun 4, 2021Incorrect Measurement; Material Protrusion/Extrusion; Incorrect Measurement; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PATIENT STATED THE END OF THE BARDIA URETHRAL CATHETER WAS TOO BIG AND PATIENT WAS BLEEDING SOMETIMES. NO MEDICAL INTERVENTION IN EVENT.

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

  MAUDE report 11942435 ↗
• MalfunctionJun 4, 2021Incorrect Measurement; Material Protrusion/Extrusion; Incorrect Measurement; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PATIENT STATED THE END OF THE BARDIA URETHRAL CATHETER WAS TOO BIG AND PATIENT WAS BLEEDING SOMETIMES. NO MEDICAL INTERVENTION IN EVENT.

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

  MAUDE report 11942434 ↗
• MalfunctionApr 21, 2021Material Protrusion/Extrusion; Sharp Edges; Material Protrusion/Extrusion; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY IN INSERTING THE CATHETER. PER FOLLOW UP VIA PHONE ON 24MAR2021 THE CUSTOMER NOTED THAT THE END OF THE CATHETER WAS VERY FLOPPY BECAUSE THE HOLES WERE OPPOSITE EACH OTHER SO IT KEPT BENDING DURING THE INSERTION WHICH MADE IT PAINFUL AND DIFFICULT TO INSERT THE FIRST 3 INCHES OF THE CATHETER. THE CUSTOMER WAS STILL ABLE TO INSERT THE CATHETER AND VOID THE BLADDER. THE CUSTOMER STATED THAT THE MATERIAL ON THE CATHETER WAS NOT SMOOTH AND WAS A LITTLE ROUGH. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 11701535 ↗
• MalfunctionMar 16, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETERS WERE TOO BIG TO FIT INTO THE PATIENT STOMA. THE PATIENT STATED THAT THE CATHETER SEEMED TO BE MADE OF SOMETHING DIFFERENT. THE PATIENT ALSO REPORTED THAT LITTLE KNOTS WERE FOUND ON THE CATHETER AND THERE WAS NO HARM OR HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497165 ↗
• MalfunctionMar 15, 2021Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETERS WERE BIG TO FIT IN THE USER STOMA. IT WAS STATED THAT THERE WERE LITTLE KNOTS ON THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485975 ↗
• InjuryFeb 16, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD GOT 3 URINARY TRACT INFECTIONS AND WAS THOUGHT THAT IT IS BECAUSE OF CATHETERS, HOWEVER, IT WAS NOT SURE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11333265 ↗
• InjuryFeb 16, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD GOT 3 URINARY TRACT INFECTIONS AND WAS THOUGHT THAT IT IS BECAUSE OF CATHETERS, HOWEVER, IT WAS NOT SURE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11333250 ↗
• InjuryFeb 16, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD GOT 3 URINARY TRACT INFECTIONS. THEY THOUGHT THAT IT WAS THE CATHETERS BUT NOT SURE AND STATED THAT THEY ONLY GOT ONE A YEAR USUALLY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11333016 ↗
• MalfunctionFeb 1, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT STATED THE END OF THE BARDIA URETHRAL CATHETER WAS TOO BIG AND THE PATIENT EXPERIENCED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 11263495 ↗
• InjuryJan 15, 2021Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD THREE URINARY TRACT INFECTIONS IN YEAR 2020 LAST AND A FEW MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER FOLLOW UP WITH CUSTOMER VIA PHONE ON 26JAN2020, THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR EACH OF THE URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11178283 ↗
• InjuryJan 14, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD THREE URINARY TRACT INFECTIONS IN YEAR 2020 AND EXPERIENCED THE LAST URINARY TRACT INFECTIONS A FEW MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER FOLLOW UP WITH CUSTOMER VIA PHONE ON (B)(6) 2020, THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR EACH OF THE URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11169980 ↗
• InjuryJan 14, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD THREE URINARY TRACT INFECTIONS IN YEAR 2020 AND EXPERIENCED THE LAST URINARY TRACT INFECTION A FEW MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER FOLLOW UP WITH CUSTOMER VIA PHONE ON 26JAN2020, THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR EACH OF THE URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11169978 ↗
• MalfunctionDec 22, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SOME OF THE CATHETERS WERE SKINNIER THAN OTHERS. PER FOLLOW UP ON 26FEB2021,THE CUSTOMER ADDED THAT THE CATHETERS ARE ALL THE SAME LENGTH BUT SOME DIAMETER OF SOME OF THE CATHETERS ARE SMALLER AND NOTED 20 CATHETERS WERE AFFECTED.

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

  MAUDE report 11060581 ↗
• MalfunctionDec 18, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD NOT ABLE TO INSERT URETHRAL CATHETER, SO NEED TO SCHEDULE APPOINTMENT WITH UROLOGIST.

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

  MAUDE report 11039473 ↗
• InjuryDec 3, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT TWO URINARY TRACT INFECTIONS PER MONTH AND THESE URETHRAL CATHETERS WERE THE CAUSE. STATED ONE OR TWO CAME THROUGH THAT WERE NOT PURIFIED AND CAUSED THE PATIENT TO GET AN INFECTION. ALSO PATIENT HAD BEEN USING THIS CATHETER FOR MANY YEARS. PER FOLLOW UP, THE CUSTOMER CONFIRMED THERE WAS NO STERILITY BREACH IN THE PACKAGING. THE INFECTIONS WERE TREATED WITH ANTIBIOTICS.

  Patient problems: No Code Available; Urinary Tract Infection

  MAUDE report 10937801 ↗
• InjuryNov 30, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT TWO URINARY TRACT INFECTIONS PER MONTH AND THESE URETHRAL CATHETERS WERE THE CAUSE. STATED ONE OR TWO CAME THROUGH THAT WERE NOT PURIFIED AND CAUSED THE PATIENT TO GET AN INFECTION. ALSO PATIENT HAD BEEN USING THIS CATHETER FOR MANY YEARS. PER FOLLOW UP, THE CUSTOMER CONFIRMED THERE WAS NO STERILITY BREACH IN THE PACKAGING. THE INFECTIONS WERE TREATED WITH ANTIBIOTICS.

  Patient problems: No Code Available; Urinary Tract Infection

  MAUDE report 10919714 ↗
• MalfunctionNov 13, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE URETHRAL CATHETERS WERE NOT DRAINING THE PATIENT'S BLADDER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23OCT2020 THE PATIENT HAD ISSUES WITH THE CATHETERS NOT DRAINING THE BLADDER, BECAUSE SOMETIMES THE EYELETS WERE TOO CLOSE TO THE TIP OF THE CATHETER, AND SOMETIMES THE EYELETS WERE TOO SMALL.

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

  MAUDE report 10837302 ↗
• MalfunctionNov 13, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE URETHRAL CATHETERS WERE NOT DRAINING THE PATIENT'S BLADDER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23OCT2020 THE PATIENT HAD ISSUES WITH THE CATHETERS NOT DRAINING THE BLADDER, BECAUSE SOMETIMES THE EYELETS WERE TOO CLOSE TO THE TIP OF THE CATHETER, AND SOMETIMES THE EYELETS WERE TOO SMALL.

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

  MAUDE report 10837195 ↗
• MalfunctionNov 11, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE URETHRAL CATHETER WAS HAVING A TINY BUBBLE OF RUBBER ON THE SIDE OF THE CATHETER AND STATED THAT SOMETIMES IT CAUSED SIGNIFICANT DISCOMFORT AND TISSUE WAS QUITE SENSITIVE AND ALSO IT HURTS.

  Patient problems: Discomfort; Pain

  MAUDE report 10822684 ↗
• MalfunctionNov 10, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE URETHRAL CATHETERS WERE PAINFUL DURING INSERTION AND WITHDRAWAL. STATED PATIENT WONDERED IF THE EYELETS WERE NOT POLISHED LIKE THE ONES GOT FROM HIS DOCTOR¿S OFFICE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN WITH INSERTION AND REMOVAL OF THE CATHETER, BUT THE PAIN WAS WORSE DURING REMOVAL. NO MEDICAL INTERVENTION WAS REQUIRED. THE EYELETS ON THE CATHETERS DID NOT FEEL AS SMOOTH PREVIOUS CATHETERS THE CUSTOMER HAD RECEIVED. PATIENT NOTED THAT THIS ONLY OCCURED WITH THE CATHETERS FROM MOST RECENT ORDER AND USED CATHETERS FROM THE PREVIOUS ORDER RECENTLY WITH SAME ITEM, THERE WERE NO ISSUES.

  Patient problems: Pain

  MAUDE report 10817307 ↗
• MalfunctionSep 25, 2020Biocompatibility; Therapeutic or Diagnostic Output Failure; Biocompatibility

  IT WAS REPORTED THAT THE RED RUBBER CATHETER COULD NO LONGER PASS THROUGH THE PATIENT'S URETHRA. IT CAUSED PAIN AND SWELLING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain; Swelling

  MAUDE report 10590244 ↗
• InjurySep 1, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND GOT TREATED BY UROLOGIST AND WHILE THERE NO ALLEGATION AGAINST ANY PRODUCT. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME, HISTORICALLY PROVIDED THE PATIENT WITH THE 802414 AND 39304. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON 01SEP2020 VIA PHONE, HE HAS EXPERIENCED MULTIPLE UTIS AND RECEIVED TREATMENT WITH ANTIBIOTIC THERAPY PER A UROLOGIST.

  Patient problems: Urinary Tract Infection

  MAUDE report 10479165 ↗
• MalfunctionJun 25, 2020Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT HAD STRICTURE AND CATHETER COULD NOT BE INSERTED. PATIENT ALSO STATED THAT THE 14F MAY BE TOO BIG.

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

  MAUDE report 10194775 ↗