Bardex® Lubricath® Temperature Sensing Foley Catheter 119418MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741046155), received between Apr 28, 2020 and Apr 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2020Component Misassembled; Positioning Problem; Therapeutic or Diagnostic Output Failure; Component Misassembled

  IT WAS REPORTED THAT WHEN ASKED WHY THE TEMP SENSING FOLEY PRODUCT DID NOT PERFORM AS INTENDED, THE RESPONDENT SAID IT WAS THE POSITION FOR THE DRAINAGE.

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

  MAUDE report 10007418 ↗