Bard® Rubber Utility Catheter 277714Recalls & 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
Quick summary
This Bard rubber utility catheter is a single-use urinary catheter. Most of the 45 reports describe physical problems with the catheters — sharp spurs or pieces sticking out, parts not put together correctly, catheters being the wrong length or size in the box, and difficulty placing them — along with irritation, pain and urinary tract infections in some patients. Eight injuries were reported and no deaths. No recalls name this device. Reports have dropped sharply, from 17 in the earlier 12 months to 2 in the most recent 12.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00801741034107), received between Jun 18, 2021 and Sep 21, 2026 — classified as 8 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (12 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
- Incorrect Measurement12
- Component Misassembled8
- Difficult to Insert6
- Adverse Event Without Identified Device or Use Problem4
- Biocompatibility3
- Material Protrusion/Extrusion3
- Naturally Worn3
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Urinary Tract Infection6
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fungal Infection1
- Irritability1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848824 ↗MalfunctionAug 14, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261493 ↗MalfunctionAug 11, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209947 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PT STATES HE IS GETTING UTIS, WANTED TO KNOW IF CATHETERS ARE STERILE. TRANSFERRED TO URO FOR ADD'T SUPPORT. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED.\ UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 23442076 ↗MalfunctionJul 2, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
PATIENT SAID THE CATHETERS CAUSED IRRITATION. PATIENT SAID THERE WAS POINTY PIECES STICKING OUT OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385361 ↗MalfunctionJun 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED BY THE PATIENT THAT SOME CATHETERS HAVE SPURS ON THEM. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22358756 ↗MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE LONGER THAN THEY WERE SUPPOSED TO BE. THEY WERE DIFFERENT AND THEY WERE DIFFERENT SIZES IN THE BOX. (LOT#NGJU4040, LOT#NGJX4385, LOT#NGJY3751, LOT#NGJY3956, LOT#NGJ0031 AND LOT#NGJZ0589).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053403 ↗MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE LONGER THAN THEY WERE SUPPOSED TO BE. THEY WERE DIFFERENT AND THEY WERE DIFFERENT SIZES IN THE BOX. (LOT#NGJU4040, LOT#NGJX4385, LOT#NGJY3751, LOT#NGJY3956, LOT#NGJ0031 AND LOT#NGJZ0589).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053398 ↗MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE LONGER THAN THEY WERE SUPPOSED TO BE. THEY WERE DIFFERENT AND THEY WERE DIFFERENT SIZES IN THE BOX. (LOT#NGJU4040, LOT#NGJX4385, LOT#NGJY3751, LOT#NGJY3956, LOT#NGJ0031 AND LOT#NGJZ0589).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053397 ↗MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE LONGER THAN THEY WERE SUPPOSED TO BE. THEY WERE DIFFERENT AND THEY WERE DIFFERENT SIZES IN THE BOX. (LOT# NGJU4040, LOT# NGJX4385, LOT# NGJY3751, LOT# NGJY3956, LOT# NGJ0031 AND LOT# NGJZ0589).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053395 ↗MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE LONGER THAN THEY WERE SUPPOSED TO BE. THEY WERE DIFFERENT AND THEY WERE DIFFERENT SIZES IN THE BOX. (LOT#NGJU4040, LOT#NGJX4385, LOT#NGJY3751, LOT#NGJY3956, LOT#NGJ0031 AND LOT#NGJZ0589).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052812 ↗MalfunctionMay 20, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE PATIENT COULD NOT INSERT RED RUBBER INTERMITTENT CATHETERS WITHOUT LUBRICANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052802 ↗MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE LONGER THAN THEY WERE SUPPOSED TO BE. THEY WERE DIFFERENT AND THEY WERE DIFFERENT SIZES IN THE BOX. (LOT#: NGJU4040, LOT#: NGJX4385, LOT#: NGJY3751, LOT#: NGJY3956, LOT#: NGJ0031 AND LOT#: NGJZ0589).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22051801 ↗MalfunctionFeb 25, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THERE WAS NO HOLE IN THE TIP OF INTERMITTENT CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21457902 ↗MalfunctionDec 12, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE RED RUBBER CATHETER OPENING WAS NOT OPEN FOR DRAINING URINE. THE CUSTOMER REPORTED ISSUES WITH LOT# NGJT2541, LOT# NGJT0620, LOT# NGJV0178, AND LOT# NGHZ2118.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914172 ↗MalfunctionDec 12, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE RED RUBBER CATHETER OPENING WAS NOT OPEN FOR DRAINING URINE. THE CUSTOMER REPORTED ISSUES WITH LOT# NGJT2541, LOT# NGJT0620, LOT# NGJV0178, AND LOT# NGHZ2118.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913885 ↗MalfunctionDec 12, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE RED RUBBER CATHETER OPENING WAS NOT OPEN FOR DRAINING URINE. THE CUSTOMER REPORTED ISSUES WITH LOT# NGJT2541, LOT# NGJT0620, LOT# NGJV0178, AND LOT# NGHZ2118.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913217 ↗MalfunctionDec 12, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE RED RUBBER CATHETER OPENING WAS NOT OPEN FOR DRAINING URINE. THE CUSTOMER REPORTED ISSUES WITH LOT# NGJT2541, LOT# NGJT0620, LOT# NGJV0178,AND LOT# NGHZ2118.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913211 ↗MalfunctionNov 4, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INTERMITTENT CATHETER HAD WHITE EXCORIATED AREAS ALONG THE LENGTH OF THE CATHETER. THEY APPEARED AS THOUGH THEY WOULD BREAK IF THEY WERE USED INSIDE OF A PATIENT. THEY WERE NOT EXPIRED. MULTIPLE LOTS WERE AFFECTED (LOT# NGGQ3749 AND LOT# UNK). PER FOLLOW UP VIA EMAIL ON 10DEC2024, CUSTOMER STATED THIS AFFECTED THEIR FULL SUPPLY OF RED CATHETERS. THE MARKINGS WERE DISCOVERED DURING ROUTINE NURSING CARE AND ALL PRODUCTS REMOVED. NO MEDICAL INTERVENTION WAS REQUIRED. DEVICE WAS REPLACED. FULL SUPPLY OF RED CATHETERS HAD WHITE MARKINGS ALONG THE LENGTH OF THE CATHETERS THAT LOOKED SIMILAR TO STRETCH MARKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20598616 ↗MalfunctionNov 1, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INTERMITTENT CATHETER HAD WHITE EXCORIATED AREAS ALONG THE LENGTH OF THE CATHETER. THEY APPEARED AS THOUGH THEY WOULD BREAK IF THEY WERE USED INSIDE OF A PATIENT. THEY WERE NOT EXPIRED. MULTIPLE LOTS WERE AFFECTED (LOT # NGGQ3749 AND LOT# UNK).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20586335 ↗InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE NURSE STATED THE PATIENT HAD INTERMITTENT URINARY TRACT INFECTION WHILE USING THE INTERMITTENT CATHETER WHICH DOCTOR WAS TREATING.
Patient problems: Urinary Tract Infection
MAUDE report 20522282 ↗MalfunctionAug 7, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT INTERMITTENT CATHETER WAS PAINFUL AND WAS DIFFICULT TO INSERT AND NOT ABLE TO PUT ONE IN. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Pain
MAUDE report 19933569 ↗MalfunctionJun 11, 2024Inadequacy of Device Shape and/or Size; Material Twisted/Bent; Inadequacy of Device Shape and/or Size; Material Twisted/Bent
IT WAS REPORTED THAT THE INTERMITTENT CATHETER BENT WHEN INSERTING. PER FOLLOW UP ON 03JUL2024, IT WAS REPORTED THAT THE ALL-PURPOSE CATHETER WAS NOT USEFUL TO THEM DUE TO THEIR CONDITION. THEY ENDED UP DONATING THE CATHETERS TO THEIR HOME HEALTH AGENCY AND NO SAMPLE IS AVAILABLE. NO LOT NUMBER WAS REPORTED. CUSTOMER WAS NOW USING A FOLEY CATHETER, WHICH WAS BETTER FOR THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509368 ↗MalfunctionJun 7, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CAP OF THE INTERMITTENT CATHETER¿S FUNNEL CONNECTOR WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19483900 ↗MalfunctionJan 9, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE PATIENT USED INTERMITTENT CATHETER AND THEY WERE UNABLE TO EMPTY BLADDER AT ALL. THEY LOOKED AT FUNNEL END AND NOTICED A WHITE POWDER ON IT. THEY REMOVED IMMEDIATELY AND FOUND THAT THERE WAS NO HOLE IN THE INSERTED END WHICH WAS THE REASON THEY WERE UNABLE TO EMPTY BLADDER. SINCE THEY ARE SUPPOSED TO BE STERILE, AND THEY ENSURED THAT THEY WERE CLEANED AND SANITIZED BEFORE OPENING AND USING A CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474835 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
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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