Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray 919214ARecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00801741040122), received between May 16, 2022 and Sep 10, 2026 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (43 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Decrease in Pressure; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722290 ↗
• MalfunctionNov 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A DIFFICULTY IN REMOVING THE FOLEY CATHETER BALLOON WATER. FOUR CONSECUTIVE INCIDENTS OCCURRED IN WHICH THE BALLOON COULD NOT BE REMOVED AFTER STERILE DISTILLED WATER WAS INJECTED DURING PRETESTING. PER FOLLOW UP INFORMATION RECEIVED ON 27OCT2025, STATED THAT ALL 4 INCIDENTS WERE FROM SAME BATCH MYKR3301 WITH DIFFERENT MANUFACTURING LOT NGKN3120X3 AND NGKN0583.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452713 ↗
• MalfunctionOct 27, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT STERILE WATER DID NOT DRAIN FROM FOLEY CATHETER DURING PRE-TEST. PER NOTIFICATION FROM INVESTIGATOR ON 18FEB2026, IT WAS REPORTED THAT THE BALLOON WAS NOTED TO INFLATED ASYMMETRICALLY, FOUND DURING SAMPLE EVALUATION ON 27JAN2026. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391052 ↗
• MalfunctionOct 21, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO CATHETER JELLY IN FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347476 ↗
• MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIS WAS A CASE OF FOREIGN MATTER CONTAMINATION. UPON OPENING THE FOLEY TRAY, A BLACK FOREIGN OBJECT WAS FOUND, SO USE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337603 ↗
• MalfunctionAug 27, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE CUFF CHECK THE FOLEY CATHETER STERILE WATER DID NOT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904322 ↗
• MalfunctionAug 6, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT, FLUID COULD NOT BE COMPLETELY DRAINED FROM FOLEY CATHETER DURING PRETEST. IT REQUIRED 12 HOURS TO DRAIN THE ENTIRE AMOUNT OF FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726535 ↗
• MalfunctionJul 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST THE FOLEY CATHETER HAD DIFFICULTY IN DRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576306 ↗
• MalfunctionJul 8, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST THE FOLEY CATHETER STERILE WATER DID NOT DRAIN. PER NOTIFICATION FROM UCC ON 17DEC2025, IT WAS REPORTED THAT ASYMMETRICAL BALLOON WAS FOUND DURING SAMPLE EVALUATION ON 05NOV2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438030 ↗
• MalfunctionJun 16, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT STERILE WATER DID NOT DRAIN FROM FOLEY CATHETER AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212801 ↗
• MalfunctionJun 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST, THE WATER COULD NOT BE COMPLETELY DRAINED FROM THE FOLEY CATHETER. MEDICON SYRINGE USED TO DRAIN THE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187497 ↗
• MalfunctionJun 9, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETEST, STERILE WATER CAN BE POURED IN, BUT NOT ALL OF IT COMES BACK WHEN DRAINING WATER FROM THE FOLEY CATHETER. THEY TOOK OUT A NEW TRAY AND DEALT WITH THE PROBLEM. MEDICON SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166828 ↗
• MalfunctionMay 30, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT STERILE WATER WAS INJECTED DURING THE PRE-TEST, BUT IT WAS DIFFICULT TO DRAIN WATER FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114734 ↗
• MalfunctionMay 21, 2025Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060872 ↗
• MalfunctionMay 5, 2025Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960333 ↗
• MalfunctionApr 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, IN THE FOLEY CATHETER, ONE SIDE WAS BULGED AT A RATIO OF 9:1 AND THERE WAS ALSO GARBAGE IN THE TRAY. PER SAMPLE EVALUATION RECEIVED ON 24MAR2025, DURING SAMPLE EVALUATION THE SYRINGE HAD DIFFICULTY TO DEFLATE WAS FOUND. PER SAMPLE EVALUATION RECEIVED ON 24MAR2025, DURING SAMPLE EVALUATION CUFFING WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21815514 ↗
• MalfunctionApr 10, 2025Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814075 ↗
• MalfunctionApr 9, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRETEST, THE FOLEY CATHETER WAS BULGED ONE SIDE AT THE RATIO OF 10:0. PER INVESTIGATOR'S NOTIFICATION RECEIVED ON 24MAR2025, IT WAS REPORTED THAT THE RETURNED SYRINGE DID NOT DEFLATE IN UNDER 5 MINUTES DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806392 ↗
• MalfunctionMar 31, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DUST BUILDUP, COLORED STRINGS, MESSY PACKING OF SHEETS AND INCONSISTENT CATHETER PACKING FORMAT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 19MAR2025, STATED THAT WHEN THE PACKAGE WAS OPENED AT THE OFFICE, A VARIETY OF DEFECTS WERE FOUND, JUST AS DESCRIBED, SO THE ISSUE WAS REPORTED. ALSO 20 PRODUCTS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729825 ↗
• MalfunctionMar 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD HAIR ATTACHED TO ITS TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697625 ↗
• MalfunctionMar 13, 2025Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594229 ↗
• MalfunctionMar 13, 2025Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593411 ↗
• MalfunctionMar 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, THEY TRIED TO DRAIN THE STERILE WATER FROM THE FOLEY CATHETER AFTER INJECTING IT, BUT IT DID NOT DRAIN OUT COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559417 ↗
• MalfunctionMar 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, STERILE WATER WAS INJECTED INTO THE FOLEY CATHETER, BUT IT WAS NOT POSSIBLE TO DRAIN IT. WE ALSO CHECKED WITH THE SALES DEPARTMENT AND FOUND THAT RESISTANCE WAS FELT FROM THE TIME THE WATER WAS INJECTED, AND IT WAS ALMOST IMPOSSIBLE TO DRAIN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559297 ↗
• MalfunctionMar 5, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, WATER COULD NOT BE DRAINED FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525368 ↗