Bard All Purpose Urethral CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 108
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 7 models of Bard All Purpose Urethral Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between May 9, 2017 and Feb 19, 2025 — classified as 3 injuries, 105 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bard All Purpose Urethral Catheter problems
Device problems
- Device Damaged Prior to Use25
- Material Integrity Problem21
- Misassembled21
- Material Deformation13
- Incorrect Measurement12
- Material Twisted/Bent8
- Positioning Problem7
- Product Quality Problem6
Patient problems
- No Known Impact Or Consequence To Patient68
- No Patient Involvement63
- No Clinical Signs, Symptoms or Conditions12
- No Information10
- No Consequences Or Impact To Patient8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Urinary Tract Infection2
- Blood Loss1
Bard All Purpose Urethral Catheter models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® All Purpose Urethral Catheter 0094160CATHETER, UROLOGICAL88 reports
- Bard® All Purpose Urethral Catheter 0094140CATHETER, UROLOGICAL9 reports
- Bard® All Purpose Urethral Catheter 0094100CATHETER, UROLOGICAL4 reports
- Bard® All Purpose Urethral Catheter 0094080CATHETER, UROLOGICAL2 reports
- Bard® All Purpose Urethral Catheter 0094120CATHETER, UROLOGICAL2 reports
- Bard® All Purpose Urethral Catheter 0094180CATHETER, UROLOGICAL2 reports
- Bard® All Purpose Urethral Catheter 0094200CATHETER, UROLOGICAL1 report
Recent Bard All Purpose Urethral Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2025Material Split, Cut or Torn; 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 21409856 ↗MalfunctionFeb 19, 2025Material Split, Cut or Torn; 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21409609 ↗MalfunctionSep 30, 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 20332590 ↗MalfunctionMay 25, 2022Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn
IT WAS REPORTED THAT THE RED RUBBER INTERMITTENT CATHETER APPEARED TO BE BREAKING DOWN AROUND THE EYES. IT WAS STATED THAT SAFETY CONCERN WAS NOTICED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14496600 ↗MalfunctionDec 3, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS DEFECTIVE UPON ARRIVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12928884 ↗MalfunctionSep 9, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE RED RUBBER INTERMITTENT CATHETER WAS FLIMSY AND THE PATIENT FELT THAT IT WAS MADE DIFFERENTLY. PER FOLLOW UP VIA PHONE ON (B)(6) 2021 THE CUSTOMER NOTICED A CHANGE IN THE CATHETERS THEY USED FOR YEARS. THE CATHETERS WERE FLIMSY WHICH MAKES THEM DIFFICULT TO USE. THEY FEEL LIKE THE DIAMETER WAS SMALLER THAN THE INDICATED 14 FR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12448826 ↗InjuryApr 7, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE PATIENT HAD BEEN USING A COUPLE OF BARD RED RUBBER CATHETERS FOR YEARS (PCN (B)(4)). PATIENT WANTED TO KNOW WHY THERE WAS SUCH A DIFFERENCE IN THE DUROMETER BETWEEN THESE TWO CATHETERS AND REPORTED THAT CATHETER 94200 WAS THE HARDEST, AND PATIENT HAD JUST POKED A HOLE IN THE COLON. PATIENT HAD THEN STARTED ANTIBIOTICS AND DECIDED TO GO TO THE HOSPITAL LATER. PATIENT DID NOT THINK THAT THIS WAS A DEFECT IN THE PRODUCT, AND WAS ONLY CURIOUS AS TO WHY THERE WAS SUCH A DIFFERENCE BETWEEN THE TWO CATHETERS. PER FOLLOW UP VIA PHONE ON (B)(6) 2021, THE CUSTOMER STATED THAT THE 94200 CATHETERS IN THE MOST RECENT ORDER WERE HARDER THAN PREVIOUS ONCE RECEIVED. THE CUSTOMER NOTED THE CATHETER POKED A HOLE IN THE COLON AND RESULTED IN BLEEDING. THE BLEEDING STOPPED ON ITS OWN BUT THE CUSTOMER WAS PRESCRIBED ANTIBIOTICS AS A PRECAUTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11626777 ↗MalfunctionFeb 12, 2021Improper Chemical Reaction; Physical Resistance/Sticking; Improper Chemical Reaction; Physical Resistance/Sticking
IT WAS REPORTED THAT THE URETHRAL CATHETER WAS TACKY OR VERY STICKY ON THE INSERTION TIP, AND NOT SMOOTH. THE USER FOUND THE SAME ISSUE MORE OFTEN. PER FOLLOW UP INFORMATION RECEIVED ON 19JAN2021, THE USER DID NOT PUT LUBE ON THE CATHETER. IN OTHER CATHETER, THE USER FOUND WITH THE SAME ISSUE AND PUT LUBE ON IT, WHICH WAS STILL TACKY AND CAUSED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury
MAUDE report 11321987 ↗MalfunctionFeb 10, 2021Improper Chemical Reaction; Physical Resistance/Sticking; Improper Chemical Reaction; Physical Resistance/Sticking
IT WAS REPORTED THAT THE URETHRAL CATHETER WAS TACKY OR VERY STICKY AT THE INSERTION TIP AND NOT SMOOTH. THE USER FOUND THE SAME ISSUE MORE OFTEN. PER FOLLOW UP INFORMATION RECEIVED ON 19JAN2021 THE USER DID NOT PUT THE LUBRICITY ON THE CATHETER. IN OTHER CATHETER THE USER FOUND WITH THE SAME ISSUE AND PUT LUBRICITY ON IT WHICH WAS STILL TACKY AND CAUSED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11309423 ↗MalfunctionDec 21, 2020Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE 9094100 - BRD9094100 - CATH ROBINSON 10FR WAS SHIPPED INSTEAD OF REF (B)(4). IDENTIFIED IN STOCK AND PREVENTED FROM USING.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11044442 ↗MalfunctionDec 21, 2020Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE 9094100 - BRD9094100 - CATH ROBINSON 10FR WAS SHIPPED INSTEAD OF REF 0094100.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11044441 ↗MalfunctionDec 21, 2020Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE 9094100 - BRD9094100 - CATH ROBINSON 10FR WAS SHIPPED INSTEAD OF REF (B)(4). IDENTIFIED IN STOCK AND PREVENTED FROM USING.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11044434 ↗MalfunctionDec 15, 2020Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT CATHETERS WERE TOO THICK AND UNCOMFORTABLE.
Patient problems: Discomfort
MAUDE report 11006496 ↗MalfunctionOct 23, 2020Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE CATHETER WAS FOUND DIFFICULT TO INSERT INSIDE THE BLADDER WHICH CAUSED THE SPHINCTER TO SPASM; ALSO THE PATIENT EXPERIENCED INCOMPLETE BLADDER URINATION DUE TO THE USE OF CATHETER. THE COMPLAINANT REPORTEDLY STATED THAT THE NEWER BARD CATHETERS MEASURED ABOUT 0.020 OF AN INCH LARGER IN DIAMETER WHEN COMPARED WITH OLDER BARD 9414 CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10730103 ↗MalfunctionOct 23, 2020Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE CATHETER WAS FOUND DIFFICULT TO INSERT INSIDE THE BLADDER WHICH CAUSED THE SPHINCTER TO SPASM; ALSO THE PATIENT EXPERIENCED INCOMPLETE BLADDER URINATION DUE TO THE USE OF CATHETER. THE COMPLAINANT REPORTEDLY STATED THAT THE NEWER BARD CATHETERS MEASURED ABOUT 0.020 OF AN INCH LARGER IN DIAMETER WHEN COMPARED WITH OLDER BARD 9414 CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10729683 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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