Bard® Urine Meter Foley Catheter Tray With Bardex® Lubricath® Foley Catheter 902916Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741024863), received between Apr 25, 2017 and Sep 29, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940513 ↗
• MalfunctionDec 27, 2024

  ATTEMPTED TO INSERT FOLEY CATHETER FOR PATIENT WITH URINARY RETENTION, THE CATHETER WAS DISCOLORED AT THE END CONNECTED TO THE FOLEY BAG, WHILE DOING BALLOON CHECK THE BALLOON INFLATED BUT WOULD NOT DEFLATE. STOPPED PROCEDURE GOT ANOTHER KIT FROM THE SUPPLY CLOSET AND ENCOUNTERED THE SAME PROBLEM WITH THE DISCOLORATION AND BALLOON. STOPPED PROCEDURE BROUGHT 2 KITS BACK THIS TIME SO I DID NOT HAVE TO GO FAR IF THE SAME PROBLEM PERSISTED, THE 3RD KIT WAS NOT DISCOLORED AND THE BALLOON WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025898 ↗
• MalfunctionFeb 29, 2024

  REGISTERED NURSE (RN) WAS ORDERED TO PLACE A FOLEY CATHETER IN A PATIENT. BEFORE ATTEMPTING TO PLACE CATHETER USING ASEPTIC TECHNIQUE, SHE INFLATED THE CATHETER PRIOR TO INSERTION. IT WAS EASY TO INFLATE BUT DIFFICULT TO DEFLATE. THE FOLEY CATHETER WAS EXCHANGED FOR A SIMILAR DEVICE AND THE INSERTION WAS SUCCESSFUL. THE DEFECTIVE DEVICE WAS SEQUESTERED, AND EMERGENCY DEPARTMENT (ED) MANAGER TRIED TO DEFLATE THE DEVICE. AFTER SEVERAL ATTEMPTS, SHE WAS ABLE TO DEFLATE THE CATHETER WITH MUCH EFFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807609 ↗
• MalfunctionFeb 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THEY HAD ISSUES THE PAST COUPLE OF MONTHS WITH LEAKS AND COMPLAINTS OF PATIENT DISCOMFORT RELATED TO THE FOLEY TRAY. PER ADDITIONAL INFORMATION RECEIVED ON 08APR2024, FOLEY WAS CHANGED WHEN PAIN OR DISCOMFORT WAS REPORTED BY THE PATIENTS. STAFF TOLD THAT ON FRIDAY THAT THEY WERE STILL HAD A GOOD NUMBER OF PATIENTS COMPLAINING ABOUT DISCOMFORT. ALSO THAT THERE WAS SOME SORT OF VAPOR LOCK ISSUE GOING ON WHERE THEY WERE NOT DRAINING. WHEN THEY DID FINALLY DRAIN IT WAS 500-700 ML. NO MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 18766505 ↗
• MalfunctionSep 20, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT INFLATING. THEY NEEDED REPLACEMENT OF SEVERAL BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782296 ↗
• MalfunctionNov 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BARD CATHETER WAS LEAKING. THERE HAVE ALSO BEEN REPORTED CASES REGARDING THE WAY THE PACKAGE IS PACKED. IN ORDER TO REMAIN STERILE, THE GLOVES SHOULD BE THE FIRST ITEM YOU TOUCH IN THE PACKAGING, NOT THE STERILE TOWEL (DRAPE). IT WAS ALSO REPORTED THAT A CATHETER WAS FOUND FUSED SO THAT IT COULD NOT BE EMPTIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10852644 ↗
• MalfunctionApr 27, 2020Gel Leak; Gel Leak; Leak/Splash

  IT AS REPORTED THAT UPON OPENING THE KIT, HEALTH PROFESSIONALS NOTICED 10 CC SYRINGE OF STERILE WATER HAD LEAKED OUT, LEAVING APPROXIMATELY 0.5 CC STERILE WATER LEFT IN THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10002217 ↗
• MalfunctionMar 27, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE ICU STATED THAT THE CATHETER WAS CLOGGED. A SMALL AMOUNT OF SEDIMENT WAS NOTED, BUT NOT ENOUGH TO CLOG THE FOLEY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9889905 ↗
• MalfunctionMar 24, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE ICU STATED THAT THE CATHETER WAS CLOGGED. THEY STATED THAT THERE WAS A SMALL AMOUNT OF SEDIMENT THAT SHOULD NOT HAVE BEEN ENOUGH TO CLOG THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9874288 ↗
• MalfunctionMar 20, 2020Gel Leak

  IT WAS REPORTED THAT GEL LEAKED FROM THE SYRINGE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9861266 ↗
• MalfunctionMar 6, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE PATIENT IN THE CCU AND IT FELL OUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9801614 ↗
• MalfunctionMar 5, 2020Filling Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON IS NOT FILLING PROPERLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9794452 ↗
• MalfunctionFeb 5, 2020Deflation Problem; Device Slipped; Gas/Air Leak; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED TO BE FLIPPED AND THE FOLEY SLIPPED OUT. THEY NOTICED THE BALLOON WAS LEAKING AIR BACK INTO THE CATHETER AND HAD DEFLATED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9671078 ↗
• MalfunctionApr 25, 2017Fluid/Blood Leak; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE TRAY THE BETADINE HAD LEAKED INSIDE OF THE TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6519270 ↗