Bard® Urine Meter with Bag 153215ARecalls & reported problems
C. R. Bard, Inc. · Bard® Urine Meter with Bag · Class 2
All models of Bard Urine Meter with Bag (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741033179), received between Jun 1, 2021 and Mar 22, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Restricted Flow rate2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2023Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT TWO DIFFERENT PATIENTS THEY HAD TO REPLACE FOLEY CATHETERS BECAUSE THE ONES THEY HAD CONTINUED TO AIR LOCK AND HAD UP TO 1000MLS OF URINE NOT DRAINING FROM THE PATIENT¿S BLADDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16590419 ↗MalfunctionJun 1, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE NURSE WAS HAVING QUALITY ISSUES WITH 16 FR FOLEY CATHETERS. THE CATHETERS WERE NOT FUNCTIONING PROPERLY AND HAD ONE THE PREVIOUS DAY IN WHICH THEY HAD TO UNHOOK IT FROM THE LEG AND DRAINED 700 CC. ALSO THE NURSE WANTED TO KNOW WHETHER THERE WERE CATHETERS IN PEDIATRIC SPECIFIC SIZES. PER FOLLOW UP VIA EMAIL ON 21MAY2021 THE CUSTOMER WAS UNSURE WHAT THE MALFUNCTION WAS ONLY THAT IT WAS NOT DRAINING UNLESS MANIPULATED LESS THAN 24 HRS THE CATHETER WAS IN PLACE WHEN THE ISSUE WAS OCCURRED. PER FOLLOW UP VIA EMAIL ON 12AUG2021 IT WAS STATED THAT THE URINE WAS DRAINED INTO THE BAG BUT VERY LITTLE WHICH WAS PROMPTED THE AID TO MANIPULATE THE CATHETER TO GET MORE OUT. THE CUSTOMER WAS UNSURE WHAT THEY ARE REFERRING TO WITH THE VAPOR LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11914051 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber 802001C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER117 reports
- Bard® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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