Bard Urethral Catheterization Tray with Red Rubber CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 4 models of Bard Urethral Catheterization Tray with Red Rubber Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Jun 6, 2017 and Nov 9, 2023 — classified as 4 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Component Missing” (27 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 Urethral Catheterization Tray with Red Rubber Catheter problems
Device problems
- Component Missing27
- Inaccurate Flow Rate8
- No Flow7
- Component Misassembled3
- Material Fragmentation2
- Obstruction of Flow2
- Partial Blockage2
- Patient-Device Incompatibility2
Patient problems
- No Known Impact Or Consequence To Patient28
- No Patient Involvement18
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions10
- Foreign Body In Patient2
- No Information2
- Urinary Retention2
- Urinary Tract Infection2
Bard Urethral Catheterization Tray with Red Rubber Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Urethral Catheterization Tray with Red Rubber Catheter 772415CATHETER, UROLOGICAL27 reports
- Bard® Urethral Catheterization Tray with Red Rubber Catheter 772414CATHETER, UROLOGICAL21 reports
- Bard® Urethral Catheterization Tray with Red Rubber Catheter 771215CATHETER, URETERAL, GASTRO-UROLOGY3 reports
- Bard® Urethral Catheterization Tray with Red Rubber Catheter 774415CATHETER, URETERAL, GASTRO-UROLOGY1 report
Recent Bard Urethral Catheterization Tray with Red Rubber Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE SUB FOR THEIR STRAIGHT INTERMITTENT CATHETER KIT WAS NOW JUST A CATHETER. TO REDUCE INFECTION AND MAKE IT EASIER FOR NURSING, IT WOULD BEST BE A KIT FOR A SUB PRODUCT. CUSTOMER BIN WAS NOT BEING STOCKED BECAUSE THE SUB HAS NOT BEEN FOUND. THEY NEED TO HAVE AN APPROPRIATE SUB FOUND SOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18104509 ↗InjuryJul 21, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled
IT WAS REPORTED THAT IN AND OUT CATH BEING DONE ON LABOR PATIENT WITH EPIDURAL TO EMPTY BLADDER. NURSING STAFF STATED THAT THE INTERMITTENT CATHETER WAS INTACT WHEN INSERTED INTO URETHRA BUT CAME OUT MISSING THE TOP PORTION. IT WAS STATED THAT THE PATIENT ENDED UP HAVING TO UNDER CYSTOSTOMY AFTER DELIVERY. AS PER INVESTIGATOR NOTIFICATION ON 06JUL2022, IT WAS STATED THAT AN ADDITIONAL RED RUBBER CATHETER WAS RETURNED FOR SAMPLE EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 15079770 ↗MalfunctionMay 9, 2022Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT THE TRAY (MATERIAL# - 772417) AND THE WAY IT WAS PACKAGED. STATED THAT THREE TRAYS HAVE BEEN LIKE THIS SO FAR (MATERIAL# 772417-LOT# UNK). ALSO STATED THAT THE SUBSTITUTE URETHRAL CATHETER TRAY HAD THE STERILE GLOVES LOCATED UNDER THE DRAPE WHICH AS A RESULT ONE WAS UNABLE TO STERILELY PLACE THE DRAPE UNLESS THE NURSE GRABBED THEIR OWN SET OF GLOVES (MATERIAL# 772414-LOT# NGFZ3767).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14336927 ↗InjuryApr 6, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled
IT WAS REPORTED THAT IN AND OUT CATH BEING DONE ON LABOR PATIENT WITH EPIDURAL TO EMPTY BLADDER. NURSING STAFF STATED THAT THE INTERMITTENT CATHETER WAS INTACT WHEN INSERTED INTO URETHRA BUT CAME OUT MISSING THE TOP PORTION. STATED THAT THE PATIENT ENDED UP HAVING TO UNDER CYSTOSTOMY AFTER DELIVERY.
Patient problems: Foreign Body In Patient
MAUDE report 14021789 ↗MalfunctionAug 11, 2021Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE RED RUBBER FOLEY IN THE STRAIGHT CATHETER KIT WAS BLOCKED AND DOES NOT DRAIN. AFTER THE CATHETER FAILED, THE CUSTOMER TRIED TO FLUSH WATER BUT NOT ABLE TO FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12309634 ↗MalfunctionJun 30, 2021Component Missing; Component Missing
IT WAS REPORTED THAT THE LUBRICATION PACKET WAS MISSING FROM URETHRAL TRAY FOR LOT NUMBER NGFQ4266. IT WAS FURTHER REPORTED THAT THE COLLECTION CONTAINER WAS MISSING FROM ANOTHER URETHRAL TRAY FOR LOT NUMBER NGFP0800.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12097354 ↗MalfunctionJun 30, 2021Component Missing; Component Missing
IT WAS REPORTED THAT THE LUBRICATION PACKET WAS MISSING FROM URETHRAL TRAY FOR LOT NUMBER NGFQ4266. IT WAS FURTHER REPORTED THAT THE COLLECTION CONTAINER WAS MISSING FROM ANOTHER URETHRAL TRAY FOR LOT NUMBER NGFP0800.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12094603 ↗MalfunctionDec 5, 2020Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT DESPITE CORRECT ANATOMICAL LOCATION PLACEMENT THE STRAIGHT CATHETER DID NOT DRAIN THE URINE. A SECOND STRAIGHT CATHETER WAS PLACED IN THE SAME LOCATION AND THE URINE WAS RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10950723 ↗MalfunctionDec 4, 2020Component Missing; Component Missing
IT WAS REPORTED THAT TWO TRAYS DID NOT CONTAIN THE IODINE SWABSTICKS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10946101 ↗MalfunctionDec 4, 2020Component Missing; Component Missing
IT WAS REPORTED THAT TWO TRAYS DID NOT CONTAIN THE IODINE SWABSTICKS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10945938 ↗MalfunctionNov 24, 2020Short Fill; Short Fill
IT WAS REPORTED THAT THE KIT DID NOT CONTAIN ANY POVIDONE SWABS AND ALSO THEY WERE DRY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10892621 ↗MalfunctionNov 24, 2020Component Missing; Component Missing
IT WAS REPORTED THAT THE KIT DID NOT CONTAIN ANY POVIDONE SWABS AND ALSO THEY WERE DRY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10889669 ↗MalfunctionOct 29, 2020Component Missing
2 STRAIGHT CATH KITS STATED THEY HAD (2) NON LATEX, STERILE GLOVES IN THE PACKAGE AND DID NOT HAVE THE GLOVES IN THE PACKAGE.
Patient problems: Insufficient Information
MAUDE report 10754629 ↗MalfunctionOct 20, 2020Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER WAS HAVING LABELING ISSUES AND MIXED PRODUCT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10705640 ↗MalfunctionJul 14, 2020Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate
IT WAS REPORTED THAT THERE WAS NO URINE GOT BACK INTO THE BAG, WHEN THE CATHETER WAS FULLY INSERTED. MSS ADVISED THE USER TO MAKE SURE THAT THE CLAMP WAS RELEASED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10271092 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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