Bard® Rubber Utility Catheter 277710Recalls & reported problems
C. R. Bard, Inc. · Bard® Rubber Utility Catheter · Class 2
All models of Bard Rubber Utility Catheter (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741034084), received between Jul 6, 2022 and Mar 30, 2026 — classified as 3 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn9
- Naturally Worn8
- Adverse Event Without Identified Device or Use Problem3
- Fracture1
- Improper Chemical Reaction1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Urinary Tract Infection2
- Discomfort1
- Exposure to Body Fluids1
- Unspecified Infection1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PT SAID HAS UTI'S BUT NOT SURE WHY. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 24720289 ↗MalfunctionJun 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT INTERMITTENT CATHETER HAD A HOLE AT THE TOP SECTION. DURING INSTILLATION OF THE CYTOTOXIC MEDICATION IT WAS NOTED THAT THERE WAS A HOLE IN THE CATHETER AND SOME OF THE MEDICATION LEAKED OUT. THE CATHETER WAS IMMEDIATELY CLAMPED AND REMOVED. A NEW CATHETER WAS INSERTED.
Patient problems: Exposure to Body Fluids
MAUDE report 22329764 ↗MalfunctionApr 2, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THE RED RUBBER INTERMITTENT CATHETER USED FOR TONSILLECTOMY AND ADENOIDECTOMY WAS CRACKED AND DRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751860 ↗MalfunctionApr 2, 2025Fracture; Fracture
IT WAS REPORTED THAT THE RED RUBBER INTERMITTENT CATHETER USED FOR TONSILLECTOMY AND ADENOIDECTOMY WAS CRACKED AND DRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751322 ↗MalfunctionFeb 21, 2025Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN#277710 (BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390), (BATCH #NGGQ3730)], [PCN #277708 (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682)], [PCN #94180 (BATCH #NGEY3152)], [PCN #94120 (BATCH #NGEV4510)], [PCN #56110 (BATCH #NGFW2958)], [PCN #56114 (BATCH #NGGV2774)]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05MAR2025, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434308 ↗MalfunctionFeb 21, 2025Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN #(B)(4) (BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390), (BATCH #NGGQ3730)], [PCN #(B)(4) (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682)], [PCN #(B)(4) (BATCH #NGEY3152)], PCN #(B)(4) (BATCH #NGEV4510)], [PCN #(B)(4) (BATCH #NGFW2958)], [PCN #(B)(4) (BATCH #NGGV2774)]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05MAR2025, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434298 ↗MalfunctionFeb 21, 2025Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN#277710 (BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390), (BATCH #NGGQ3730)], [PCN #277708 (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682)], [PCN #94180 (BATCH #NGEY3152)], [PCN #94120 (BATCH #NGEV4510)], [PCN #56110 (BATCH #NGFW2958)], [PCN #56114 (BATCH #NGGV2774)]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05MAR2025, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432321 ↗MalfunctionFeb 21, 2025Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN #(B)(6) (BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390), (BATCH #NGGQ3730)], [PCN #(B)(6) (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682)], [PCN #(B)(6) (BATCH #NGEY3152)], ]PCN #(B)(6) (BATCH #NGEV4510)], [PCN #(B)(6) (BATCH #NGFW2958)], [PCN #(B)(6) (BATCH #NGGV2774)]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432196 ↗MalfunctionFeb 21, 2025Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN #277710 (BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390), (BATCH #NGGQ3730)], [PCN #277708 (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682)], [PCN #94100 (BATCH #NGEY3152)], PCN #94120 (BATCH #NGEV4510)], [PCN #56110 (BATCH #NGFW2958)], [PCN #56114 (BATCH #NGGV2774)]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05MAR2025, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432195 ↗MalfunctionSep 26, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT 3 OF THE RED RUBBER LATEX INTERMITTENT CATHETERS THAT APPEARED TO BE DRY ROTTED OR USED AS THEY HAD WHITE LINES ON THEM. TWO OF THEM WERE 10FR WITH LOTS (LOT#NGHX2731 AND LOT#NGJT2540) AND ONE OF THEM WAS A 16FR WITH LOT (LOT#NGEU3771). CUSTOMER HAD SEVERAL OTHER SIZES OF THESE, SO THIS SEEMED TO BE ISOLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20310061 ↗MalfunctionSep 26, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT 3 OF THE RED RUBBER LATEX INTERMITTENT CATHETERS THAT APPEARED TO BE DRY ROTTED OR USED AS THEY HAD WHITE LINES ON THEM. TWO OF THEM WERE 10FR WITH LOTS (LOT#NGHX2731 AND LOT#NGJT2540) AND ONE OF THEM WAS A 16FR WITH LOT (LOT#NGEU3771). CUSTOMER HAD SEVERAL OTHER SIZES OF THESE, SO THIS SEEMED TO BE ISOLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309921 ↗MalfunctionFeb 2, 2023Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn
IT WAS REPORTED THAT MANY OF THE FOLEY CATHETERS WERE DISCOLORED, CRACKED, AND HAD ODD SCRATCHES ON THEM. THE CUSTOMER HAD PROBABLY 50 OR MORE CATHETERS ON THEIR DESK WITH THIS ISSUE OF VARIOUS SIZES AND MODELS, AND ALL OF THEM WERE WITHIN THEIR EXPIRATION DATES. TWO OF THE WORST CATHETERS WERE PCN# (B)(4) HAD TURNED COMPLETELY BROWN AND SPOTTY, AND THE PCN# 277710 HAD WHITE CRACKS IN VARIOUS PLACES ON THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16283856 ↗MalfunctionOct 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER HAD A PINHOLE NEAR THE END WHICH CAUSED LEAKAGE OF BLADDER CHEMOTHERAPY. CUSTOMER ALSO STATED THAT THEY ADMINISTER HAZARDOUS DRUGS VIA THIS CATHETER AND THIS WAS A HUGE SAFETY ISSUE. IT WAS ALSO REPORTED THAT THERE WAS A BROWN SPOT RIGHT WHERE THE CATHETER WIDENS TO THE FLANGE ON THE END. CUSTOMER REPORTED THAT THERE ARE TWO LOT#NGGS0456 AND LOT#NGGR2390 WITH THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15542033 ↗MalfunctionSep 24, 2022Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER HAD A PINHOLE NEAR THE END WHICH CAUSED LEAKAGE OF BLADDER CHEMOTHERAPY (LOT#NGGS0456, LOT#NGGR2390). CUSTOMER ALSO STATED THAT THEY ADMINISTER HAZARDOUS DRUGS VIA THIS CATHETER AND THIS WAS A HUGE SAFETY ISSUE (LOT#NGGS0456, LOT#NGGR2390). IT WAS ALSO REPORTED THAT THERE WAS A BROWN SPOT RIGHT WHERE THE CATHETER WIDENS TO THE FLANGE ON THE END(LOT#NGGS0456, LOT#NGGR2390).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15475817 ↗InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE RED RUBBER CATHETERS WERE CAUSING DISCOMFORT AND THE PATIENT GOT AN INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION. PER CUSTOMER VIA PHONE (B)(6) 2022, CUSTOMER STATED THEY WENT TO THE HOSPITAL FOR AN INFECTION AND WAS TREATED WITH ANTIBIOTICS IN THE HOSPITAL. CUSTOMER STATED THEY WERE NO LONGER USES THE CATHETERS.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 15208664 ↗InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS HAD THREE URINARY TRACT INFECTION IN THE LAST 2 MONTHS. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. PER CUSTOMER VIA PHONE ON (B)(6) 2022, CUSTOMER STATED THAT THEY DID NOT KNOW WHETHER THE URINARY TRACT INFECTIONS WERE FROM CATHETERS OR NOT. AND THEY WERE PRESCRIBED WITH THREE DIFFERENT ANTIBIOTICS, NITROFURANTOIN, CEFDINIR AND CEPHALEXIN, ONE FOR EACH OF THE URINARY TRACT INFECTIONS THEY HAS HAD. IT WAS STATED THAT THE CUSTOMER HAD RECOVERED FROM URINARY TRACT INFECTIONS AND WAS FINE NOW.
Patient problems: Urinary Tract Infection
MAUDE report 14936725 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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