Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray 900114ARecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741032929), received between Dec 5, 2019 and Dec 4, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (17 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A DIRT ON THE PAPER WRAPPING THE GLOVES IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723074 ↗
• MalfunctionSep 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SYRINGE WATER INJECTION WAS STIFF, AND THE FOLEY CATHETER BULGES UNEVENLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23179864 ↗
• MalfunctionSep 8, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED, THERE WAS NO SYRINGE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991775 ↗
• MalfunctionAug 15, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BEFORE USE, THERE WAS NO CATHETER JELLY IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818724 ↗
• MalfunctionAug 7, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT THE SYRINGE IN THE FOLEY TRAY WAS NOT FILLED WITH STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736094 ↗
• MalfunctionJul 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY SYRINGE WAS NOT INCLUDED AND THERE ARE ONLY TWO COTTON BALLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469522 ↗
• MalfunctionJul 3, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT WHEN THE USER OPENED THE FOLEY TRAY, IT WAS STICKY, AND THE JELLY WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394814 ↗
• MalfunctionJun 30, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN OPENED THE FOLEY TRAY PRODUCT, THE CATHETER JELLY IN THE TRAY WAS NOT THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357386 ↗
• MalfunctionJun 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING, POVIDONE WAS NOT INCLUDED IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234698 ↗
• MalfunctionJun 16, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT AFTER OPENING CATHETER JELLY'S PACKAGING WAS DAMAGED, BUT IT WAS STICKY. THERE WAS ALSO BLACK FOREIGN MATTER MIXED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211128 ↗
• MalfunctionJun 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST THE STERILE WATER COULD NOT BE DRAINED FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175675 ↗
• MalfunctionMay 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DRAIN WATER. THE FOLEY CATHETER BALLOON WAS DIFFICULT TO DRAIN WATER AND TAKES A LONG TIME TO DEFLATE, SO THEY REFRAINED FROM USING IT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 16MAY2025, STATED THAT THERE WAS PATIENT INVOLVEMENT WITH NO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114735 ↗
• MalfunctionMay 22, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BLUE PLASTIC WRAP ON THE FOLEY CATHETER BODY WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069816 ↗
• MalfunctionApr 28, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT BEFORE USE, THE FOLEY TRAY HAD NO STERILE WATER IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917573 ↗
• MalfunctionApr 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING INSERTION, IT BECAME IMPOSSIBLE TO INJECT OR REMOVE WATER FROM FOLEY CATHETER, SO IT WAS SIMPLY PULLED OUT AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840261 ↗
• MalfunctionApr 14, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN THE INFLATION WAS CHECKED BEFORE PLACEMENT ON THE PATIENT, FOLEY CATHETER BALLOON WAS FULLY INFLATED ON ONLY ONE SIDE. PER INVESTIGATOR'S NOTIFICATION RECEIVED ON 25MAR2025, IT WAS REPORTED THAT DIFFICULT TO DEFLATE DUE TO RETURNED SYRINGE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832609 ↗
• MalfunctionMar 31, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST THE FOLEY CATHETER WATER DRAINAGE WAS SLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730528 ↗
• MalfunctionMar 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SYRINGE TIP BROKE OFF DURING PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687831 ↗
• MalfunctionMar 7, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING CUFF TEST, STERILE DISTILLED WATER DOES NOT DRAIN FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546464 ↗
• MalfunctionMar 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, FOLEY CATHETER COULD NOT DRAIN WATER. 10CC OF WATER DRAINED OUT WHEN REINSERTED. THERE WAS DIFFICULTY IN INJECTING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504512 ↗
• MalfunctionMar 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WATER IN THE FOLEY CATHETER DID NOT DRAIN DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503456 ↗
• MalfunctionFeb 7, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT DRAIN WATER DURING THE PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332375 ↗
• MalfunctionFeb 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRETEST, THE FOLEY CATHETER BALLOON SWELLED TO ONE SIDE AT THE RATIO OF 10:0. SO, THEY DISCONTINUED THE USE. PER INVESTIGATOR'S NOTIFICATION RECEIVED ON 15JAN2025, IT WAS REPORTED THAT DIFFICULT TO DEFLATE FOUND DURING SAMPLE EVALUATION ASSOCIATED TO THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292317 ↗
• MalfunctionJan 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT STERILE DISTILLED WATER DID NOT DRAIN DURING FOLEY CATHETER CUFF CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124499 ↗
• MalfunctionJan 6, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ONE-SIDED BULGING WAS OBSERVED DURING PRE-TEST OF FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079656 ↗