Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119308MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741039874), received between Dec 22, 2023 and Dec 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE TEMPERATURE SENSING CATHETER DID NOT WORK FOR INSERTION AND THE TEMPERATURE PROBE DID NOT READ ACCURATELY. NO PATIENT HARM REPORTED. PRODUCT WAS NOT MEETING CLINICAL NEED FOR TEMPERATURE MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388561 ↗
• MalfunctionDec 22, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE SENSING CATHETER DID NOT WORK FOR INSERTION AND THE TEMPERATURE PROBE DID NOT READ ACCURATELY. NO PATIENT HARM REPORTED. PRODUCT WAS NOT MEETING CLINICAL NEED FOR TEMPERATURE MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382880 ↗