Bardia® Coude Olive Tip Urethral Foley Catheter 802512Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741039034), received between Apr 16, 2018 and Sep 14, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (9 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 23 most recent of 23 reports, 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 ↗
• MalfunctionFeb 20, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THEY SENT THEM AN ORDER OF COUDE INTERMITTENT CATHETER, AND THESE ARE THE ONES THEY NORMALLY USED. HOWEVER, THEY SAID, THIS ORDER WAS RUST COLORED INSTEAD OF, AND THEY SAID THEY WERE NOT AS FLEXIBLE AND DID NOT WORK AS WELL, AS THE RED ONES THEY WAS GETTING BEFORE. THEY WOULD LIKE TO SPOKE WITH SOMEONE AT THE MANUFACTURER REGARDING WHETHER THE MANUFACTURING OF THE PRODUCT HAD CHANGED, OR WHETHER THE ONES THEY GOT WERE JUST OLD AND HAD BEEN SITTING IN A WAREHOUSE FOR TOO LONG. THEY ALSO SAID THEY WERE COMPRESSED IN THE BOX AND THE FUNNELS WERE MISSHAPEN. THEY ALSO SAID THAT THEY WAS REUSING THE CATHETERS AND THEY BECOME MORE FLEXIBLE AS THEY CLEAN AND SANITIZES THEM. PATIENT SAID THEY DID HAVE SAMPLES AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425674 ↗
• MalfunctionDec 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT OVER A YEAR NOW THE URETHRAL COUDE CATHETERS WERE BENT AND THE ANGLE WAS INCORRECT AND THE PATIENT WANTS TO EXCHANGE FOR NEW CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925597 ↗
• MalfunctionFeb 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 10 CATHETERS WERE IN A DIFFERENT COLOR AND DESCRIBED THEM AS BEING TWISTED AND UNABLE TO USE THEM. IT WAS NOTED THAT 38 CATHETERS WERE TWISTED DARKER DISCOLORING AND UNABLE TO USE THEM.

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

  MAUDE report 11272919 ↗
• MalfunctionFeb 2, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE DIFFERENT IN COLOR. ALSO DESCRIBED THEM AS BEING TWISTED AND WAS UNABLE TO USE THEM.

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

  MAUDE report 11266614 ↗
• MalfunctionNov 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD BEEN GOING THROUGH ISSUES WITH THE CATHETER. PATIENT STATED THAT THE CATHETERS WERE TOO STRAIGHT AND DID NOT BEND CORRECTLY WHERE THE COUDE TIP WAS. IT CAUSED DISCOMFORT AND BLEEDING AND ALSO PATIENT MENTIONED THAT THEY HAD TO GO TO THE HOSPITAL. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10897424 ↗
• MalfunctionNov 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD BEEN GOING THROUGH ISSUES WITH THE CATHETER. PATIENT STATED THAT THE CATHETERS WERE TOO STRAIGHT AND DID NOT BEND CORRECTLY WHERE THE COUDE TIP WAS. IT CAUSED DISCOMFORT, BLEEDING, AND ALSO PATIENT MENTIONED THAT THEY HAD TO GO TO THE HOSPITAL. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10897246 ↗
• MalfunctionNov 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ON GOING ISSUES WITH THE SAME CATHETER. ALSO STATED THE CATHETERS WERE TOO STRAIGHT AND NOT BEND CORRECTLY WHERE THE COUDE TIP WAS. IT CAUSED DISCOMFORT AND BLEEDING AND ALSO PATIENT MENTIONED THAT THEY HAD TO GO TO THE HOSPITAL. THE REPRESENTATIVE DID TRY TO ASSIST THE PATIENT BUT THE MANUFACTURER DID NOT CHECK THEIR PRODUCTS BEFORE THEY PUT THEM IN THE BOX AND THEY SHOULD NOT BE SENDING THESE PRODUCTS OUT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10897181 ↗
• MalfunctionNov 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ON GOING ISSUES WITH THE SAME CATHETER. ALSO STATED THE CATHETERS WERE TOO STRAIGHT AND NOT BEND CORRECTLY WHERE THE COUDE TIP WAS. IT CAUSED DISCOMFORT AND BLEEDING. PATIENT HAD TO GO TO THE HOSPITAL. THE REPRESENTATIVE DID TRY TO ASSIST THE PATIENT BUT THE MANUFACTURER DID NOT CHECK THEIR PRODUCTS BEFORE THEY PUT THEM IN THE BOX AND THEY SHOULD NOT BE SENDING THESE PRODUCTS OUT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10893141 ↗
• MalfunctionNov 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ON GOING ISSUES WITH THE SAME CATHETER. ALSO STATED THE CATHETERS WERE TOO STRAIGHT AND NOT BENT CORRECTLY WHERE THE COUDE TIP WAS. IT CAUSED DISCOMFORT AND BLEEDING. THE PATIENT WENT TO THE HOSPITAL. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10893067 ↗
• MalfunctionSep 2, 2020Difficult to Insert; Failure to Align; Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT STATED THE CATHETER ALIGNMENT WAS NOT CORRECT, IT WOULD NOT INSERT RIGHT AND WAS DIFFICULT TO INSERT . ALSO STATED IN THE PAST, PATIENT HAD CATHETERS WHERE COUDE TIP WAS NOT PERFECTLY A 45 DEGREE ANGLE. STATED THIS CAUSED PATIENT BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10482455 ↗
• MalfunctionMar 19, 2020Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS ARRIVED BENT IN THE PACKAGING. CUSTOMER WAS ABLE TO USE THE CATHETERS WITHOUT ISSUE.

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

  MAUDE report 9853036 ↗
• MalfunctionFeb 19, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT AND TWISTED IN THE PACKING BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 9726434 ↗
• MalfunctionJan 3, 2020Nonstandard Device; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE COUDE CATHETER WAS TOO BENT AT THE TIP AND PATIENT WAS UNABLE TO USE IT.

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

  MAUDE report 9545338 ↗
• MalfunctionDec 30, 2019Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TIP ON 5 CATHETERS WAS LARGER THAN NORMAL.

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

  MAUDE report 9530466 ↗
• MalfunctionSep 5, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE TIP OF THE COUDE INTERMITTENT CATHETER WAS NOT CURVED ENOUGH. NO MEDICAL INTERVENTION REPORTED. PER ADDITIONAL INFORMATION FROM THE CUSTOMER, THERE WAS A SMALL AMOUNT OF BLEEDING WHEN USING THE CATHETER AS IT WAS "DIFFICULT TO NAVIGATE PAST THE PROSTATE."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8967648 ↗
• MalfunctionAug 16, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT TIP OF THE COUDE INTERMITTENT CATHETER WAS NOT CURVED ENOUGH. THE PATIENT EXPERIENCED BLEEDING; NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8903637 ↗
• MalfunctionSep 11, 2018Misassembled; Device Markings/Labelling Problem; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE MARKED AS COUDE, HOWEVER SEEMED STRAIGHT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7864873 ↗
• MalfunctionSep 11, 2018Misassembled; Device Markings/Labelling Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE MARKED AS COUDE, HOWEVER SEEMED STRAIGHT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7864493 ↗
• MalfunctionSep 11, 2018Misassembled; Appropriate Device Problem Term/Code Not Available; Misassembled

  IT WAS REPORTED THAT THE MARKED COUDE CATHETERS SEEMED STRAIGHT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7864356 ↗
• MalfunctionJul 16, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE COUDE CATHETERS WERE NOT BENT ENOUGH AND SEEMED STRAIGHT.

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

  MAUDE report 7689982 ↗
• MalfunctionJun 20, 2018Break; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COUDE CATHETER TIP WAS BENT MORE THAN USUAL. THE PATIENT WAS REPORTEDLY ABLE TO BEND THE CATHETERS HIMSELF AND STILL USE THEM. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7621823 ↗
• MalfunctionApr 16, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS ROUGH CAUSING THE PATIENT TO EXPERIENCE SOME SELF-LIMITED BLEEDING. THE PATIENT WAS ALLEGEDLY ABLE TO USE THE CATHETER AND DRAIN URINE.

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

  MAUDE report 7434605 ↗