Bard® Urine Meter Foley Catheter Tray, Bardex® All-Silicone Temp-Sensing Foley 849408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741029332), received between Nov 5, 2018 and Jan 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionJan 2, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER WAS LEAKING AROUND THE INSERTION SITE, BUT NOT INTO THE CATHETER. THE CATHETER WAS PLACED ALL THE WAY TO THE HUB AND THE BLADDER WAS PRESSED WITH NO URINE RETURN. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY. URINE WAS IMMEDIATELY NOTED IN THE SECOND CATHETER AND THE BALLOON WAS THEN INFLATED WITH NO RESISTANCE. THE COMPLAINANT REPORTED THE FIRST CATHETER WAS PLACED PER POLICY AND PLACEMENT WAS CORRECT WITH EASY VISUALIZATION AND INSERTION.

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

  MAUDE report 9538908 ↗
• MalfunctionNov 5, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED THAT, PRIOR TO THE USE, THE TEMPERATURE PROBE SENSOR WAS COILED AND THE TIP OF THE PROBE WAS NOT NEAR THE TIP OF THE CATHETER. THE TEMPERATURE PROBE WAS 2-3 INCHES FROM THE TIP OF THE CATHETER. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8039507 ↗