Bardex I.C. Complete Care Urine Meter Foley TrayRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of Bardex I.C. Complete Care Urine Meter Foley Tray by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between May 3, 2017 and Mar 25, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Component Missing” (7 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 Bardex I.C. Complete Care Urine Meter Foley Tray problems
Device problems
- Component Missing7
- Short Fill5
- Device Contamination with Chemical or Other Material4
- Tear, Rip or Hole in Device Packaging4
- Gel Leak3
- Material Fragmentation3
- Material Split, Cut or Torn2
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Bardex I.C. Complete Care Urine Meter Foley Tray models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® I.C. Complete Care® Urine Meter Foley Tray 303014ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES14 reports
- Bardex® I.C. Complete Care® Urine Meter Foley Tray 903014ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES10 reports
- Bardex® I.C. Complete Care® Urine Meter Foley Tray 903016ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® I.C. Complete Care® Urine Meter Foley Tray 903018ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
- Bardex® I.C. Complete Care® Urine Meter Foley Tray 303016ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
Recent Bardex I.C. Complete Care Urine Meter Foley Tray adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Difficult to Remove; Fitting Problem
IT WAS REPORTED THERE WAS A DIFFICULTY IN DRAINING WATER FROM THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690114 ↗MalfunctionMar 11, 2026Wrong Label
IT WAS REPORTED THAT DURING THE PRE-TEST, WATER COULD BE INTRODUCED BUT NOT DRAINED. ALSO, IT'S A 773 (LATEX) BUT FOR SOME REASON THERE IS A 6630 (SIILCONE) CATHETER ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572171 ↗MalfunctionNov 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN OPENED THE TRAY, HAIR WAS FOUND INSIDE, SO USER REFRAINED FROM USING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495279 ↗MalfunctionNov 4, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT IN THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466904 ↗MalfunctionNov 4, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE SYRINGE WAS NOT INCLUDED THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466898 ↗MalfunctionOct 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT, AFTER OPENING, FOREIGN MATTER FOUND IN THE FOLEY TRAY AS IT WAS NOT SEALED IN A SMALL BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416400 ↗MalfunctionOct 28, 2025Gel Leak; Gel Leak
IT WAS REPORTED THAT BEFORE USE THE WATER-BASED LUBRICANT BROKE AND LEAKED INTO THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404916 ↗MalfunctionOct 28, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THERE WAS A SYRINGE TROUBLE DUE TO THIS WATER DID NOT DRAIN FROM THE FOLEY CATHETER DURING PRE-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404746 ↗MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BLACK FOREIGN OBJECT WAS PRESENT WHEN TRAY WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357713 ↗MalfunctionOct 9, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HAIR WAS FOUND ON THE BOTTOM OF THE FOLEY TRAY. IT HAD BEEN SECURED WITH TAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23257348 ↗MalfunctionSep 26, 2025Component Missing; Component Missing
IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED AND THE PATIENT WAS ABOUT TO BEGIN USING THE PRODUCT, IT HAD TO DISCONTINUE TO USE DUE TO A SHORTAGE OF SYRINGES FILLED WITH STERILE WATER. THERE WAS A SHORTAGE OF 10MM SYRINGES FILLED WITH STERILE WATER. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26AUG2025, STATED THAT STERILE WATER IN THE SYRINGE WAS NOT ENOUGH. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 03SEP2025, STATED THAT SYRINGE HAD BEEN LOST AND MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154632 ↗MalfunctionSep 12, 2025Component Missing; Component Missing
IT WAS REPORTED THAT WHEN OPENED, THE WATER-SOLUBLE LUBRICANT, BARD 10% POVIDONE-IODINE SOLUTION WAS NOT INCLUDED IN FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037632 ↗MalfunctionAug 6, 2025Component Missing; Component Missing
IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY PRODUCT THE SYRINGE CONTAINING STERILE WATER WAS NOT INCLUDED TO BEGIN WITH. HOWEVER, SINCE OTHER ITEMS WERE USABLE, THEY PREPARED AND USED STERILE WATER ON-SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22727589 ↗MalfunctionJul 25, 2025Component Missing; Component Missing
IT WAS REPORTED THAT, AFTER OPENING THE TRAY, THERE WAS NO SYRINGE INSIDE THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609423 ↗MalfunctionJul 2, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THE USER LOOKED AT THE FOLEY TRAY FROM THE OUTSIDE BEFORE OPENING IT, THE OUTER PACKAGING WAS TORN, SO THE PRODUCT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383757 ↗
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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