Bardex® Lubricath® Temperature-Sensing Urine Meter Foley Tray 909116MRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741029158), received between Feb 13, 2019 and Jun 5, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Material Fragmentation

  IT WAS REPORTED THAT WHILE INJECTING STERILE WATER THE TIP OF THE SYRINGE BROKE AND THE TIP SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410143 ↗
• MalfunctionDec 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY. THERE WAS A STAIN (INSECT OR DIRT) ON THE SURFACE OF THE SHEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23833604 ↗
• MalfunctionDec 12, 2025Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT BEFORE USE IN THE OPERATING ROOM, SLEEVE WAS CAUGHT IN THE CONNECTION POINT OF THE DRAIN BAG. SO, THEY REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794385 ↗
• MalfunctionDec 9, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USE, IMMEDIATELY AFTER OPENING THERE WAS A HOLE IN THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763961 ↗
• MalfunctionOct 30, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER OPENING THE TRAY, THE LUBRICANT PACKAGING HAD A SLIT AND WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426399 ↗
• MalfunctionOct 29, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INNER PACKAGING WAS TORN FROM THE START, IT WAS FOUND IMMEDIATELY AFTER OPENING, SO USE WAS WITHHELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416407 ↗
• MalfunctionSep 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY PRODUCT THERE WAS A BLUE PLASTIC STUCK AT THE CONNECTION POINT BETWEEN THE BAG AND CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096390 ↗
• MalfunctionJul 23, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT, WHEN THEY OPENED THE FOLEY TRAY POVIDONE-IODINE BAG WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577017 ↗
• MalfunctionJul 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND IN A STERILE GLOVE OF FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411760 ↗
• MalfunctionJun 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE, CATHETER JELLY WAS TORN AND CONTENTS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358039 ↗
• MalfunctionJun 25, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE SYRINGE CONTAINING STERILIZED WATER WAS NOT INCLUDED IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327986 ↗
• MalfunctionMay 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE PRODUCT WAS OPENED. IT WAS DISCOVERED THAT THERE WAS A HOLE IN THE PAPER WRAPPING THE TRAY. AS A PRECAUTION, TREATED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984934 ↗
• MalfunctionMar 26, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE DURING THE PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697889 ↗
• MalfunctionDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FIXED WATER LEAKED WHEN THE SYRINGE WAS INSERTED. SYRINGE OR VALVE MAY BE FAULTY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18NOV2024, STATED THAT THERE WAS NO PATIENT INVOLVEMENT, AND THE WATER LEAKED FROM SYRINGE OR VALVE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831374 ↗
• MalfunctionSep 23, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TRAY PACKAGING WAS TORN. THE DEFECT WAS FOUND BEFORE OPENING THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279273 ↗
• MalfunctionAug 1, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN CHECKING THE FOLEY TRAY PACKAGE TO CHECK THE BALLOON'S EXPANSION PRIOR TO USE, THE SYRINGE CONTAINING THE FIXED WATER WAS NOT INCLUDED, SO THE PRODUCT WAS DETERMINED TO BE DEFECTIVE, AND USE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883587 ↗
• MalfunctionJul 25, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT STERILE WATER LEAKED FROM THE SYRINGE DURING INSERTION. THERE WAS CRACK IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824579 ↗
• MalfunctionJul 23, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO USE IT, FOUND THAT THE SYRINGE WAS NOT FILLED WITH STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806353 ↗
• MalfunctionJul 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ONE OF THE TIPS OF THE SESSI WAS MISSING WHEN THE FOLEY TRAY WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774078 ↗
• MalfunctionJun 13, 2022Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PAPER THAT WRAPPED THE FOLEY TRAY KIT WAS TORN BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682145 ↗
• MalfunctionFeb 13, 2019Labelling, Instructions for Use or Training Problem; Component Missing; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE FORCEPS AND THE IODINE SWABSTICKS WERE MISSING FROM THE TRAY. REMAINING PRODUCTS WERE USED WITH NO IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337389 ↗