Bard Urine Meter with BagRecalls & reported problems across all models
C. R. Bard, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 231
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 9 models of Bard Urine Meter with Bag by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 231 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2017 and Sep 25, 2026 — classified as 12 injuries, 219 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (76 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 Urine Meter with Bag problems
Device problems
- Restricted Flow rate76
- Deformation Due to Compressive Stress58
- Fluid/Blood Leak17
- Component Misassembled13
- Material Twisted/Bent11
- Physical Resistance/Sticking10
- Disconnection9
- Device Contamination with Chemical or Other Material8
Patient problems
- No Clinical Signs, Symptoms or Conditions185
- No Consequences Or Impact To Patient26
- No Known Impact Or Consequence To Patient22
- Urinary Retention7
- Exposure to Body Fluids5
- Discomfort3
- No Information3
- Urinary Tract Infection3
Bard Urine Meter with Bag models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Urine Meter with Bag 153214ACOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- Bard® Urine Meter with Bag 153216COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER7 reports
- Bard® Urine Meter with Bag 153202COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER4 reports
- Bard® Urine Meter with Bag 153215ACOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 reports
- Bard® Urine Meter with Bag 153207COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 reports
- Bard® Urine Meter with Bag 862100COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Bard® Urine Meter with Bag 153304COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Bard® Urine Meter with Bag 153214COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
Recent Bard Urine Meter with Bag adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903553 ↗MalfunctionSep 18, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828905 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: Exposure to Body Fluids
MAUDE report 50722293 ↗MalfunctionSep 3, 2026Deformation Due to Compressive Stress
It was reported that the customer stated that they thought the way the tubing was placed inside the packaging of the tray caused the tubing to kink where it met the meter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50578067 ↗MalfunctionAug 27, 2026Complete Blockage; Physical Resistance/Sticking
It was reported that the patient received a urinary catheter during a primary cesarean section. Once in the PACU, the Registered Nurse attempted to drain the Foley catheter and observed that the drainage tube was sealed shut to the Foley bag, preventing drainage. The urinary catheter was removed, and a new catheter was placed. The RN retained the defective urinary catheter; however, the product packaging had been discarded at the time of insertion during the cesarean procedure, which occurred more than two hours earlier.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483956 ↗MalfunctionAug 19, 2026Material Fragmentation; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328800 ↗MalfunctionAug 4, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136210 ↗MalfunctionAug 3, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124260 ↗MalfunctionJul 27, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047592 ↗MalfunctionApr 8, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT A CUSTOMER WAS EXPERIENCING ISSUES WITH THE URINE METER DRAIN BAG TUBING KINKING. THE TUBING WAS KINKING AT THE POINT WHERE IT CONNECTED TO THE METER. THIS ISSUE HAD NOT BEEN PERSONALLY ENCOUNTERED PREVIOUSLY; HOWEVER, IT WAS ALSO ACKNOWLEDGED THAT NOT ALL COMPLAINTS ARE REPORTED DIRECTLY. IT WAS SUGGESTED THAT THE CUSTOMER CHECK HOW THE BAGS WERE BEING STORED TO ENSURE THAT STORAGE CONDITIONS WERE NOT CREATING A ¿MEMORY¿ IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24823520 ↗MalfunctionApr 8, 2026Restricted Flow rate
IT WAS REPORTED THAT AN ISSUE ENCOUNTERED WHEN USING A 21 ML URINE COLLECTOR WITH A 350 ML URINE METER REFERENCE (B)(4), BATCH NUMBER NGKV3431. URINE DOES NOT FLOW INTO THE URINE METER OR FLOWS POORLY. THE PROBE MUST BE PLACED ON THE FLOOR TO COLLECT THE URINE; OTHERWISE, URINE FLOW WAS LOW, WHICH RISKS SKEWING THE DIAGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821862 ↗MalfunctionApr 1, 2026Fluid/Blood Leak; Fitting Problem
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER SCREW CAP SPINS FREELY AND WON'T CLOSE AND URINE LEAKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758852 ↗MalfunctionMar 17, 2026Fracture
IT WAS REPORTED BY THE OPEN-HEART OPERATING ROOM TEAM THAT THEY HAD EXPERIENCED MULTIPLE FAILURES INVOLVING PRODUCT: A119216M. THEY NOTED TWO INSTANCES IN WHICH THE FOLEY CATHETER¿S UROMETER COMPONENT HAD DEVELOPED CRACKS, RESULTING IN URINE LEAKAGE DURING PROCEDURES. IN ONE CASE LAST WEEK, THE CATHETER HAD NEEDED TO BE REPLACED MID PROCEDURE. THIS MORNING, ANOTHER FOLEY HAD EXPERIENCED THE SAME ISSUE, LEADING TO LEAKAGE IN A CASE THAT WAS ULTIMATELY CANCELED. HOWEVER, THE BAG STILL HAD TO BE CHANGED. GUIDANCE WAS REQUESTED REGARDING NEXT STEPS FOR RESOLUTION AND INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621389 ↗MalfunctionMar 10, 2026Fracture
IT WAS REPORTED BY THE OPEN HEART OPERATING ROOM TEAM THAT THEY HAD EXPERIENCED MULTIPLE FAILURES INVOLVING PRODUCT A119216M. THEY NOTED TWO INSTANCES IN WHICH THE FOLEY CATHETER¿S UROMETER COMPONENT HAD DEVELOPED CRACKS, RESULTING IN URINE LEAKAGE DURING PROCEDURES. IN ONE CASE LAST WEEK, THE CATHETER HAD NEEDED TO BE REPLACED MID PROCEDURE. THIS MORNING, ANOTHER FOLEY HAD EXPERIENCED THE SAME ISSUE, LEADING TO LEAKAGE IN A CASE THAT WAS ULTIMATELY CANCELED. HOWEVER, THE BAG STILL HAD TO BE CHANGED. GUIDANCE WAS REQUESTED REGARDING NEXT STEPS FOR RESOLUTION AND INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24563583 ↗MalfunctionFeb 27, 2026Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED BY THE CUSTOMER THAT THE BAG AND DRAINAGE TUBE WERE FUSED TOGETHER, PREVENTING THE SYSTEM FROM DRAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475394 ↗
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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