Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray 319216ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741040160), received between Jan 12, 2018 and Sep 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE USER TRIED TO INJECT FIXED WATER IN THE FOLEY CATHETER AND THEN TRIED TO REMOVE THE WATER, BUT IT DID NOT WORK. PER INVESTIGATOR'S NOTIFICATION RECEIVED ON 12JAN2026, IT WAS REPORTED THAT ASYMMETRICAL BALLOON WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063377 ↗
• MalfunctionMay 5, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT STERILE WATER DID NOT DRAIN FROM THE FOLEY CATHETER DURING PRE-TEST. PER NOTIFICATION FROM UCC ON 08DEC2025, IT WAS REPORTED THAT ASYMMETRICAL BALLOON WAS FOUND DURING SAMPLE EVALUATION ON 30SEP2025. PER NOTIFICATION FROM UCC ON 08DEC2025, IT WAS REPORTED THAT DIFFICULT TO DEFLATE ISSUE AGAINST THE RETURNED SYRINGE WAS FOUND DURING EVALUATION ON 30SEP2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960551 ↗
• MalfunctionApr 14, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, WHEN DRAINING THE WATER IN THE FOLEY CATHETER, THE STERILE WATER DID NOT DRAIN EVEN AFTER WAITING FOR A WHILE. MEDICON SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832520 ↗
• MalfunctionDec 27, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST IN THE OUTPATIENT OPERATING ROOM, THE INFLATION VALVE DID NOT RETURN FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026174 ↗
• MalfunctionDec 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENING THE PRODUCT THERE WAS A CRACK IN THE SYRINGE IN THE FOLEY TRAY CONTAINING STERILE DISTILLED WATER, AND ONLY 5 ML OF DISTILLED WATER WAS CONTAINED. IT WAS NOTED THAT THE GIVEN LOT# WAS MYJP4408.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825174 ↗
• MalfunctionJan 12, 2018Component Missing

  IT WAS REPORTED THAT THE CORDS FOR THE CATHETER WERE MISSING FROM THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185345 ↗