Bardex I.C. Complete Care Foley TrayRecalls & reported problems across all models
C. R. Bard, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 113
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 4 models of Bardex I.C. Complete Care Foley Tray by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2017 and Aug 19, 2026 — classified as 1 injury, 112 malfunctions.
The most frequently reported specific device problem is “Component Missing” (33 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 Foley Tray problems
Device problems
- Component Missing33
- Device Contamination with Chemical or Other Material18
- Material Fragmentation18
- Short Fill16
- Gel Leak7
- Material Split, Cut or Torn5
- Physical Resistance/Sticking5
- Component Misassembled4
Patient problems
- No Clinical Signs, Symptoms or Conditions111
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Bardex I.C. Complete Care Foley Tray models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® I.C. Complete Care® Foley Tray 900014ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES82 reports
- Bardex® I.C. Complete Care® Foley Tray 900016ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES21 reports
- Bardex® I.C. Complete Care® Foley Tray 900018ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES8 reports
- Bardex® I.C. Complete Care® Foley Tray 300016ACATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
Recent Bardex I.C. Complete Care Foley Tray adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Deformation Due to Compressive Stress; Material Twisted/Bent
It was reported that the Foley Catheter was Indentation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331264 ↗InjuryFeb 25, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING INSERTION, THE CATHETER EXPERIENCED THAT DURING BALLOON EXCHANGE AND INSERTION INTO THE PATIENT THE AREA NEAR THE FUNNEL BULGED AFTER APPROXIMATELY 5 ML OF WATER WAS INJECTED, ATTEMPTS TO WITHDRAW THE WATER WERE UNSUCCESSFUL AND THE SYRINGE COULD NOT BE MOVED, RESULTING IN THE FUNNEL BEING CUT TO ALLOW WITHDRAWAL OF THE WATER, WITH NO WATER ABLE TO BE INJECTED THEREAFTER, NO KINKING OR BENDING OBSERVED OTHER THAN BULGING AFTER INJECTION, THE LOT NUMBER IDENTIFIED AS MYKQ3348, AND THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS NOT ATTEMPTED, ALSO NOTED SAME LOT HAS ALSO BEEN RECALLED, ONE UNIT WAS USED BY A PATIENT, AND THREE UNITS REMAIN UNOPENED. (TOTAL: 4 UNITS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443446 ↗MalfunctionDec 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THEY STOPPED USING THE SHEETS BECAUSE THEY FOUND A FOREIGN OBJECT ON THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796957 ↗MalfunctionDec 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING FOLEY CATHETER PLACEMENT FOR URINARY DRAINAGE IN THE WARD, THE STERILE GLOVES WERE CONTAMINATED UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700461 ↗MalfunctionNov 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN ATTEMPTING TO USE FOLEY TRAY ON A PATIENT, THE USER NOTICED A FOREIGN OBJECT ATTACHED TO THE COTTON BALL AND DISCONTINUED USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616990 ↗MalfunctionNov 5, 2025Component Missing; Component Missing
IT WAS REPORTED THAT, BEFORE USE IT WAS FOUND SYRINGE CONTAINING STERILE WATER WAS MISSING IN FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478301 ↗MalfunctionNov 3, 2025Missing Information; Missing Information
IT WAS REPORTED THAT USE OF A LATEX FOLEY CATHETER IN LATEX-ALLERGIC PATIENTS DUE TO THE ABSENCE OF LATEX LABELING IN THE LEAFLET. AN INCIDENT OCCURRED IN THE HOSPITAL WHERE A LATEX CATHETER WAS USED ON A PATIENT WITH A LATEX ALLERGY BECAUSE THE TRAYS PRODUCT LEAFLET DID NOT INDICATE THE PRESENCE OF LATEX. THE PATIENT DID NOT EXPERIENCE ANY ALLERGIC REACTION AND THERE WERE NO PARTICULAR PROBLEMS. THE DEPUTY HEAD NURSE, WHO REPORTED THIS COMPLAINT, IS QUESTIONING WHY THE MEDICON PRODUCT¿S LEAFLET DOES NOT INDICATE LATEX, AS MOST OTHER MANUFACTURERS' LATEX PRODUCTS TYPICALLY INCLUDE LATEX LABELING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23455499 ↗MalfunctionNov 3, 2025Component Missing; Component Missing
IT WAS REPORTED THAT WHEN OPENED THE FOLEY TRAY BEFORE USE, THERE WAS NO LUBRICATING JELLY OR DISINFECTANT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452644 ↗MalfunctionOct 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING THE PRE-TEST, IT WAS DIFFICULT TO DRAIN THE WATER FROM THE CATHETER, DUE TO THE SYRINGE COULD NOT BE PULLED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438155 ↗MalfunctionOct 29, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING OPENING NO COTTON BALLS WERE INCLUDED IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416384 ↗MalfunctionOct 28, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PRE-TESTING, WHEN THEY CONNECTED THE SYRINGE TO THE INFLATION VALVE AND TRIED TO INJECT WATER INTO THE BALLOON, THE SYRINGE BECAME STUCK. SYRINGE CONNECTION WAS POOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405649 ↗MalfunctionOct 28, 2025Component Missing; Component Missing
IT WAS REPORTED THAT AFTER OPENING, CATHETER JELLY WAS NOT INCLUDED IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403725 ↗MalfunctionOct 28, 2025Component Missing; Component Missing
IT WAS REPORTED THAT FOLEY CATHETER WAS PLACED ON (B)(6) 2025. THE CATHETER WAS NATURALLY REMOVED THE FOLLOWING DAY, THE (B)(6) 2025. ALSO, IT WAS FOUND NO LEAFLET WAS PRESENT IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402695 ↗MalfunctionOct 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WERE IMPURITIES IN THE CATHETER JELLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393984 ↗MalfunctionOct 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AFTER OPENING THE FOLEY CATHETER WAS FOREIGN OBJECT INSIDE THE GLOVE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393256 ↗
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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