Bard® Rubber Utility Catheter 277716Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741034114), received between Sep 14, 2021 and Sep 10, 2026 — classified as 1 injury, 22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714894 ↗
• MalfunctionSep 10, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50710953 ↗
• MalfunctionSep 1, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547364 ↗
• MalfunctionAug 22, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50391883 ↗
• MalfunctionSep 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS ALL DRY ROTTEN. NO PATIENT INJURY REPORTED AND SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23180209 ↗
• MalfunctionFeb 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE ALL-PURPOSE INTERMITTENT CATHETERS WERE DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312715 ↗
• MalfunctionMay 7, 2024Fungus in Device Environment; Device Contaminated During Manufacture or Shipping; Fungus in Device Environment; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOLEY CATHETER FOUND THIS MORNING WITH WHAT APPEARS TO BE MOLD ON IT. PRODUCT WAS SEALED AND NOT BEEN OPENED. PRODUCT WAS SEALED AND NOT BEEN OPENED. THEY WANT TO GET THIS ENTIRE LOT NUMBER PULLED AND REPLACED. THIS WOULD ALSO NEED TO BE REPORTED OUT TO FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259080 ↗
• MalfunctionDec 28, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PATIENT USED ALL PURPOSE URETHRAL CATHETERS SINCE 1998 WHEN THEY HAD BLADDER CANCER WHICH WAS DEALT WITH BY AN INDIANA POUCH PROCEDURE. PATIENT CATHETERIZED AT LEAST 4 TIMES PER DAY AND UNTIL RECENTLY THEIR PROCESS HAS BEEN UNEVENTFUL. NO INFECTIONS AND PATIENT STOMA HAVE RETAINED FULL FUNCTIONALITY. UROLOGIST MONITORED PATIENT CONDITION VERY CAREFULLY. LAST WEEK THEY NOTICED THAT THERE WERE TRACES OF BLOOD IN THEIR DISCHARGE. THIS WAS THE FIRST-TIME PATIENT EVER NOTICED ANYTHING OUT OF THE ORDINARY DURING A CATHETERIZATION. THEY IMMEDIATELY CALL THEIR PHYSICIAN AND PHYSICIAN HAD THEM DO AN EXTERNAL EXAM WHICH SHOWED NOTHING WRONG WITH PATIENT STOMA AND PHYSICIAN HAD THEM DO ANOTHER INSERTION TO SEE IF THE BLEEDING CONTINUED. FORTUNATELY, IT DID NOT, AND PHYSICIAN SUGGESTED CONTINUING THEIR ROUTINE. PATIENT DID THEIR MORNING ROUTINE AND CATHETERIZED, USING LUBE, AS USUAL. UNFORTUNATELY, A SMALL AMOUNT OF BLOOD APPEARED IN THEIR DISCHARGE. UPON WITHDRAWAL OF THE CATHETER PATIENT FELT A HANG UP THAT NORMALLY DID NOT OCCUR. A SMALL AMOUNT OF TISSUE WAS SEEN ON THE CATHETER WHICH HAS NEVER OCCURRED BEFORE. PATIENT RINSED THE CATHETER AND FELT A BUBBLE APPROXIMATELY

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

  MAUDE report 18409302 ↗
• MalfunctionMay 11, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS BIGGER THAN THE 16FR, THEY USED TO USE AND IT WAS UNCOMFORTABLE INSERTING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 16914492 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE ALL PURPOSE CATHETERS CAUSED URINARY TRACT INFECTION AND THEY WERE FLIMSY. 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 16271855 ↗
• MalfunctionJan 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING A PROBLEM WITH RED RUBBER INTERMITTENT CATHETERS FOR THE LAST TWO YEARS. SOMETIMES CATHETER CAME WITH POWDER IN THEM, AND IN THE LAST SIX MONTHS IT WAS GOTTEN PROGRESSIVELY WORSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085764 ↗
• MalfunctionNov 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A WHITE POWDERY SUBSTANCE IN THE ALL PURPOSE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745032 ↗
• MalfunctionSep 6, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE LAST LOT OF PRODUCTS CUSTOMERS RECEIVED HAVE THE DIAMETER BIGGER THAN THE OTHER LOT THEY GOT. IT CAUSED PAIN IN INSERTION AND BLEEDING WHEN USING THEM. NO MEDICAL INTERVENTION WAS REPORTED

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

  MAUDE report 15362735 ↗
• MalfunctionSep 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN CHECKING A CASE, A CUSTOMER NOTICED A FOREIGN OBJECT INSIDE OF A 16F RED RUBBER INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347354 ↗
• MalfunctionApr 6, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD FIVE ALL-PURPOSE CATHETERS THAT WERE SO BENT THEY COULD NOT USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021801 ↗
• MalfunctionMar 24, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE RUBBER PIECE IN THE INTERMITTENT CATHETER WHERE THE FLUID WAS SUPPOSED TO GO THROUGH WAS THIN AND IT BENDS NOT ALLOWING THE FLUID TO GO STRAIGHT THROUGH. CUSTOMER ALSO STATED THAT THEY HAD GONE THROUGH SEVERAL CATHETERS BECAUSE OF THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891372 ↗
• MalfunctionFeb 27, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DRAINAGE ISSUES WITH THE USE OF ALL PURPOSE CATHETER. PATIENT STATED THAT THE EYELETS WERE TOO SMALL AND NOT DRAINING ALL OF THE URINE FROM BLADDER. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON 03FEB2022, IT WAS STATED THAT ALL PURPOSE CATHETER FELT LIKE FIBERGLASS AND IT CAUSES BLEEDING.

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

  MAUDE report 13614971 ↗
• MalfunctionFeb 23, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE 4 RED RUBBER CATHETERS THAT HAD A WHITE COATING ON THEM AND CUSTOMER DID NOT FEEL COMFORTABLE USING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588891 ↗
• MalfunctionFeb 18, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DRAINAGE ISSUES WITH THE USE OF ALL PURPOSE CATHETER. PATIENT STATED THAT THE EYELETS WERE TOO SMALL AND NOT DRAINING ALL OF THE URINE FROM BLADDER. NO ADDITIONAL INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON 03FEB2022, IT WAS STATED THAT ALL PURPOSE CATHETER FELT LIKE FIBERGLASS AND IT CAUSES BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560190 ↗
• MalfunctionFeb 15, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE 4 RED RUBBER CATHETERS THAT HAD A WHITE COATING ON THEM AND CUSTOMER DID NOT FEEL COMFORTABLE USING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539199 ↗
• MalfunctionJan 20, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS SENT FROM THE OPERATING ROOM THAT WAS SUPPOSED TO BE STERILE BUT HAD A BUG THAT WAS TRAPPED INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307718 ↗
• MalfunctionNov 9, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND DISCOMFORT AND AS WELL AS BLOCKAGE WHEN USING THE ALL PURPOSE CATHETER. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783978 ↗
• MalfunctionSep 14, 2021Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE RUBBER PIECE IN THE INTERMITTENT CATHETER WHERE THE FLUID WAS SUPPOSED TO GO THROUGH WAS THIN, AND IT BENDS NOT ALLOWING THE FLUID TO GO STRAIGHT THROUGH. CUSTOMER ALSO STATED THAT THEY HAD GONE THROUGH SEVERAL CATHETERS BECAUSE OF THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468662 ↗