Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119312MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741039898), received between Nov 30, 2018 and Dec 5, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Calcified” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Calcified; Calcified

  IT WAS REPORTED THAT PATIENT WAS ON THE INCREASED INTRACRANIAL PRESSURE PROTOCOL WHICH INVOLVED BEEN ON A COOLING BLANKET WITH A CENTRAL TEMPERATURE MONITOR. THAT PATIENT TEMPERATURE READING WAS FROM A FOLEY CATHETER THAT WAS PLACED ON (B)(6). AT THE START OF THE 19L SHIFT THE TEMPERATURE READING WAS APPROPRIATE IN THE 36'S. AROUND 0000 ON (B)(6), THE PATIENT TEMPERATURE WAS ELEVATED TO 37.5 AND SCHEDULED TYLENOL WAS GIVEN. THE COOLING BLANKET WAS DECREASING TEMPERATURE APPROPRIATELY AND THEY PLACED ICE PACKS ON THE PATIENT TO TRY AND PREVENT FEVER. BY 0200 THE TEMPERATURE WAS READING 39.5 AND QUICKLY JUMPED TO 40 THEN AT 0300 WAS 41. AT 0234 THE PATIENT STARTED HAVING BRADYCARDIA TO THE 40'S. FELLOW WAS CALLED TO BEDSIDE AND EVALUATED. INCREASED INTRACRANIAL PRESSURE WAS BELOW 20, EVD WAS PATENT, PATIENT HAD APPROPRIATE BLOOD PRESSURE, AND APPROPRIATE PERFUSION. THEY GOT AM LABS EARLY TO ENSURE ELECTROLYTES WERE STABLE AND NO DROP IN HEMOGLOBIN HAD OCCURRED. THEY ALSO FLUSHED THE FOLEY TOWARDS THE BLADDER WITH 10CC OF SALINE TO ENSURE PATENCY BECAUSE IN REPORT THEY WERE TOLD THAT PATIENT HAD ISSUES WITH SEDIMENT BUILDING UP. THE FOLEY TEMP GAVE NO OBVIOUS SIGNS THAT THERE WAS AN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727825 ↗
• MalfunctionDec 4, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE FOLEY CATHETER TEMPERATURE SENSING COMPONENT WAS NOT SUCCESSFUL IN MONITORING PATIENTS' BODY TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841681 ↗
• MalfunctionFeb 14, 2024Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT TEMPERATURE SENSING FOLEY CATHETER DEFLATED AND WHEN IT CAME OUT STAFF NOTICED THE ENTIRE BALLOON SECTION WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703197 ↗
• MalfunctionNov 30, 2018Inaccurate Flow Rate; Inaccurate Flow Rate; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER DID NOT DRAIN URINE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8118805 ↗