Bardex® I.C. Complete Care® Foley Tray 900016ARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741019371), received between Jul 15, 2022 and Aug 19, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionAug 19, 2026Deformation Due to Compressive Stress; Material Twisted/Bent

  It was reported that the Foley Catheter was Indentation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331264 ↗
• InjuryFeb 25, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING INSERTION, THE CATHETER EXPERIENCED THAT DURING BALLOON EXCHANGE AND INSERTION INTO THE PATIENT THE AREA NEAR THE FUNNEL BULGED AFTER APPROXIMATELY 5 ML OF WATER WAS INJECTED, ATTEMPTS TO WITHDRAW THE WATER WERE UNSUCCESSFUL AND THE SYRINGE COULD NOT BE MOVED, RESULTING IN THE FUNNEL BEING CUT TO ALLOW WITHDRAWAL OF THE WATER, WITH NO WATER ABLE TO BE INJECTED THEREAFTER, NO KINKING OR BENDING OBSERVED OTHER THAN BULGING AFTER INJECTION, THE LOT NUMBER IDENTIFIED AS MYKQ3348, AND THE TROUBLESHOOTING PROCEDURE IN THE NOTICE DOCUMENT WAS NOT ATTEMPTED, ALSO NOTED SAME LOT HAS ALSO BEEN RECALLED, ONE UNIT WAS USED BY A PATIENT, AND THREE UNITS REMAIN UNOPENED. (TOTAL: 4 UNITS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443446 ↗
• MalfunctionOct 29, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING OPENING NO COTTON BALLS WERE INCLUDED IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416384 ↗
• MalfunctionOct 9, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE SYRINGE WAS NOT INCLUDED WHEN THEY OPENED THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257367 ↗
• MalfunctionSep 12, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN THEY OPENED THE STERILE PACK, THERE WAS NO SYRINGE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037810 ↗
• MalfunctionSep 11, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT ONLY THE SYRINGE WAS MISSING WHEN OPENED THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027176 ↗
• MalfunctionSep 9, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT, AT THE TIME OF OPENING THE FOLEY TRAY IT WAS FOUND THAT STERILE GLOVES WERE MISSING FROM THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006380 ↗
• MalfunctionSep 5, 2025Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PLACEMENT THE EASY-LOCK PART WAS STIFF THE FIRST FEW TIMES INSERTED THE SYRINGE, MAKING IT DIFFICULT TO FLUSH, OR MAKING IT DIFFICULT TO COLLECT URINE SAMPLES. THE SYRINGE WOULDN'T MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977848 ↗
• MalfunctionAug 29, 2025Nonstandard Device; Illegible Information; Nonstandard Device; Illegible Information

  IT WAS REPORTED THAT THE FOLEY TRAY LEAFLET WAS BENT, AND THE SIZE WAS NOT VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921719 ↗
• MalfunctionJun 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SYRINGE BROKE DURING STERILE WATER INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320017 ↗
• MalfunctionJun 23, 2025Material Discolored; Wrong Label; Material Discolored; Wrong Label

  IT WAS REPORTED THAT THE STICKER ON THE 16FR WAS YELLOW, SO THE USER REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310215 ↗
• MalfunctionJun 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY TRAY SYRINGE IN THE SET WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212197 ↗
• MalfunctionApr 28, 2025Fluid/Blood Leak; Short Fill; Fluid/Blood Leak; Short Fill

  IT WAS REPORTED THAT THE WHEN THE PRODUCT WAS OPENED, THE CONTENTS OF THE SYRINGE CONTAINING STERILE WATER WERE LEAKING, AND THERE WAS ALMOST NO WATER IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917885 ↗
• MalfunctionJan 16, 2025Inflation Problem; Short Fill; Inflation Problem; Short Fill

  IT WAS REPORTED THAT THE STERILE WATER HAD FLOWED BACK, BUT IT SEEMS THAT IT WAS DIFFICULT TO INJECT WATER. THE COLLECTED PRODUCT WAS ONLY A SYRINGE, NO CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169404 ↗
• MalfunctionOct 7, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THERE WAS ONLY 6 ML OF STERILE WATER IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384922 ↗
• MalfunctionSep 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE INJECTION WAS INSERTED INTO THE BALLOON AND INFLATED, THE TIP OF THE SYRINGE WAS BROKEN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 03SEP2024, STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258220 ↗
• MalfunctionSep 9, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, THEY FOUND SYRINGE WAS EMPTY WITH CRACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169148 ↗
• MalfunctionSep 6, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO CAT JELLY IN THE FOLEY TRAY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 30AUG2024, IT WAS STATED THAT THERE WAS PATIENT INVOLVEMENT AND CAT JELLY WAS A LUBRICATION JELLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157109 ↗
• MalfunctionAug 1, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO USE SYRINGE, IT BROKE OFF AT THE BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883692 ↗
• MalfunctionJul 8, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NO WATER IN THE SYRINGE WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690133 ↗
• MalfunctionJul 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE FOREIGN SUBSTANCES SUCH AS HUMAN HAIR WAS FOUND INSIDE THE DRAIN BAG UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028804 ↗