Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119218MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741046315), received between Jul 30, 2019 and Apr 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026No Display/Image

  IT WAS REPORTED THAT PATIENT HAD A TEMPERATURE SENSING FOLEY CATHETER THAT WAS NOT READING THE PATIENT TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784294 ↗
• MalfunctionMay 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOLEY CATHETER WAS LEAKING WHERE THE BAG CONNECTS TO THE GREEN DRAINAGE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320706 ↗
• MalfunctionSep 30, 2020Fluid/Blood Leak

  PATIENT STATED HER SILICON TEMP SENSING FOLEY CATHETER WAS LEAKING. THE CATHETER WAS PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020 AS PER ADDITIONAL INFORMATION RECEIVED VIA FOLLOW UP EMAIL ON 17 SEP 2020, URINE LEAKED AND NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10605951 ↗
• MalfunctionOct 28, 2019Deflation Problem; Fluid/Blood Leak; Deflation Problem

  IT WAS REPORTED THAT WHEN THE PATIENT STOOD UP, THE URINE STARTED LEAKING FROM THE MEATUS. THE CATHETER WAS REPORTEDLY REMOVED AND IT WAS NOTED THAT ONLY 8CC OF FLUID WAS LEFT IN THE BALLOON WHICH RESULTED IN THE MEATUS LEAK.

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

  MAUDE report 9243946 ↗
• MalfunctionJul 30, 2019Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE ON (B)(6) 2019. THE NURSE DEFLATED THE BALLOON TWICE, BUT MET RESISTANCE THAT FELT LIKE A ¿BARB WAS ON THE END OF THE CATHETER¿. THE PROVIDER WAS THEN CONTACTED AND GAVE ORDERS TO RE-ADVANCE THE FOLEY AND A UROLOGIST WAS CONSULTED. THE CATHETER WAS ADVANCED WITHOUT ISSUE. THE UROLOGIST REMOVED THE CATHETER ON (B)(6) 2019 WITHOUT ISSUE. PER FOLLOW UP WITH THE COMPLAINANT ON (B)(6) 2019, THE CATHETER WAS REMOVED BY DEFLATING THE BALLOON OF THE CATHETER AGAIN AND THEN PULLING THE CATHETER OUT. THIS IS THE EXTENT OF THE INFORMATION AVAILABLE.

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

  MAUDE report 8840804 ↗