Bardex® I.C. Complete Care® Temp-Sensing Foley Catheter with Urine Meter 319416AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741024450), received between Apr 26, 2017 and Oct 26, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 9, 2024Class IIOpen, Classified

   Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

   Z-2154-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionOct 26, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS STERILITY BREAKS IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697135 ↗
• MalfunctionJul 2, 2020Material Fragmentation; Material Fragmentation; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE CATHETER FAILED DURING CODE BLUE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10223758 ↗
• MalfunctionJan 10, 2019Restricted Flow rate; Device Sensing Problem; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG FROM THE TEMPERATURE SENSING FOLEY TRAY DEVELOPED A VAPOR LOCK, PREVENTING URINE FROM DRAINING INTO THE DRAIN BAG.

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

  MAUDE report 8235841 ↗
• MalfunctionFeb 2, 2018Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS MISSING FROM THE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7237076 ↗
• MalfunctionAug 21, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DRAIN BAG WOULD NOT DRAIN URINE. THE COMPLAINANT ALLEGED THAT DRAIN BAG APPEARED TO HAVE A VAPOR LOCK AND ONLY DRAINED UPON MANIPULATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6807318 ↗
• MalfunctionApr 26, 2017Component Missing

  IT WAS REPORTED THAT THE TRAY WAS MISSING THE LUBRICANT.

  Patient problems: No Information

  MAUDE report 6522771 ↗