Bard® Urine Meter with Bag 153204Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00801741033117), received between Dec 8, 2017 and Sep 25, 2026 — classified as 4 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (38 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

Recent adverse event reports

The 25 most recent of 106 reports, 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 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 ↗
• 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 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT THAT THERE WAS AN ISSUE WITH THE INTEGRITY OF A FOLEY CATHETER USED THAT MORNING 2.3/25. 16F BARD SURESTEP FOLEY REF # A902416. THERE WAS NO OBVIOUS ISSUE UPON OPENING THE PACKAGE AND INITIAL ASSESSMENT. WHEN THE CERTIFIED REGISTERED NURSE ANESTHETIST WENT TO TIP THE URIMITER FOR MEASUREMENT, URINE BEGAN SPILLING OUT OF THE TOP PART OF THE BAG, AFTER CLOSE/THOROUGH INSPECTION, THERE WAS A NOTED HOLE/ TEAR IN THE BAG. DOCTOR OF MEDICINE WAS MADE AWARE, AND FOLEY CATHETER WAS TO BE REPLACED IN THE PATIENT POST PROCEDURE. AFTER ADDITIONAL INSPECTION ONCE THE CATHETER WAS REMOVED FROM THE PATIENT AND COMPARING IT TO THE REPLACEMENT CATHETER, THEY NOTICED THERE WAS A CIRCLE HOLE IN THE UPPER RIGHT CORNER OF THE BAG THE NEW FOLEY HAD A SQUARE WHITE BACKING INSIDE THE BAG, BLOCKING THE HOLE THAT APPEARED TO BE MISSED FROM THE LEAKING BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422224 ↗
• MalfunctionJan 28, 2026Difficult to Open or Close

  IT WAS REPORTED BY STAFF THAT SEVERAL FOLEY CATHETERS PLACED IN THE BNI OR WITHIN THE LAST 24 HOURS WERE NOT DRAINING PROPERLY. SPECIFICALLY, THE SPIGOT ON THE COLLECTION BAG, WHICH SHOULD ALLOW URINE TO BE DRAINED INTO A CONTAINER FOR DISPOSAL, IS MALFUNCTIONING. THEY PERSONALLY INSPECTED A PATIENT'S BAG AND FOUND THAT IT REQUIRES SIGNIFICANT EFFORT AND DIFFICULTY TO EMPTY. THIS APPEARS TO BE A PRODUCT DEFECT, AS THEY HAVE NOT ENCOUNTERED THIS ISSUE PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206298 ↗
• MalfunctionDec 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS A KINK ON TUBING WHERE IT WENT INTO URINE METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23833203 ↗
• MalfunctionDec 10, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT, IT WAS UNABLE TO DRAIN URINE FROM THE METER BAG AS CONNECTION WAS SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770346 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FOLEY CATHETER WAS INSERTED IN THE OPERATING ROOM FOR URINARY CATHETERIZATION AND TEMPERATURE MANAGEMENT AND WAS BEING MANAGED IN THE INTENSIVE CARE UNIT WHEN URINE LEAKAGE OCCURRED FROM THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645895 ↗
• MalfunctionNov 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PRODUCT THE STERILIZATION PACK, DISCOVERED THAT THE CONNECTION BETWEEN THE INLET TUBE AND THE METER OF THE DRAIN BAG WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453316 ↗
• MalfunctionOct 28, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AFTER OPENING BEFORE USE, THE TUBE OF THE DRAIN BAG WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405652 ↗
• MalfunctionOct 24, 2025Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE, WHEN THE BOX WAS OPENED IN THE OPERATING ROOM TO INSERT A CATHETER FOR URINARY CATHETERIZATION AND TEMPERATURE CONTROL, THE INLET TUBE OF THE DRAIN BAG CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384570 ↗
• MalfunctionOct 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN PLACED ON THE FLOOR, URINE LEAKED OUT ONTO THE FLOOR, AND UPON INSPECTION, THE TUBE OF THE DRAIN BAG WAS FOUND TO BE CUT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 22OCT2025, STATED THAT IT WAS UNKNOWN WHETHER THE DRAIN BAG TUBE GOT CUT OR THE CATHETER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357698 ↗
• MalfunctionOct 17, 2025Melted; Melted

  IT WAS REPORTED TO SUPPLY DISTRIBUTION THAT PRODUCT A902916, LOT NGKS0308 WAS OPENED AND FOUND TO HAVE A FOLEY CATHETER BAG THAT WAS MELTED TO THE OPENING WHERE THEY WOULD LET URINE OUT IF THEY WERE EMPTYING A CATHETER. THE NURSE WAS UNABLE TO EMPTY THE FOLEY BECAUSE OF THE OPENING SEALED SHUT AND THEY INDICATED THEY HAD TO GET A NEW BAG. THE NURSE MENTIONED THAT WAS THE SECOND TIME THEY NOTICED THAT EXACT SAME DEFECT, BUT THEY DID NOT COLLECT THE LOT NUMBER THE FIRST TIME AROUND, NOR DID THEY SAVE THE DEFECTIVE PRODUCT. THEY HAD RECEIVED OTHER ISSUES WITH THAT PRODUCT AND LOT YET AND DID NOT HAVE THE DEVICE TO SEND BACK FOR QA BUT DID WANT TO FOLLOW UP TO SEE IF THERE WAS A NEED TO PULL THAT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324559 ↗
• MalfunctionOct 15, 2025Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT AFTER PLACEMENT IN THE PATIENT, IT WAS CONFIRMED THAT THE PRECISION DEVICE OF DRAIN BAG HAD NO READINGS, LEADING TO DISCONTINUATION OF ITS USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304284 ↗
• MalfunctionOct 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT ONE OF OUR RESIDENT¿S 18 FR LATEX FOLEY CATHETER HAD DEFECT. THE FOLEY TUBING DETACHED FROM THE RED SEAL PORTION. THEY HAD ATTACHED PHOTOS. CATHETER HAD BEEN INSERTED (B)(6) 2025 AND DETACHED TODAY (B)(6) 2025. PROVIDED LOT# WAS NGJX6349.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271583 ↗
• MalfunctionSep 17, 2025Partial Blockage; Deformation Due to Compressive Stress; Partial Blockage; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT IT WAS UNCLEAR WHETHER IT IS THE CATHETER OR THE BAG, BUT IT SEEMED THERE WAS A BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073180 ↗
• MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED AFTER OPENING THE DRAIN BAG, THE PRECISION URINE METER AND TUBE WERE DAMAGED AND DETACHED, SO USAGE WAS REFRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063378 ↗