Bardex® I.C. Tiemann Model Coude Tip Foley Catheter 0102SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741017087), received between Aug 8, 2017 and Feb 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• InjuryFeb 13, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE PATIENT REQUESTED TO USE THE RESTROOM AND WHEN RETURNED TO BED, CATHETER WAS NO LONGER IN PLACE AND WAS LYING ON BED. IT WAS STATED THAT THE CATHETER WAS NOT PULLED BY PATIENT. ON EXAM OF THE CATHETER, IT WAS NOTICED THAT THE BALLOON WAS NO LONGER ATTACHED AND WAS COMPLETELY REMOVED FROM COUDE CATHETER. HEMATOMA WAS SEEN ON ULTRASOUND, MANUAL IRRIGATION ORDERED, HEMATURIA RESOLVED. PATIENT WAS TO FOLLOW UP WITH UROLOGY AS OUTPATIENT.

  Patient problems: Hematoma; Hematuria

  MAUDE report 16363040 ↗
• MalfunctionAug 8, 2017Inflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT INFLATE; THEREFORE, THE SHAFT OF THE CATHETER INFLATED ABOVE THE INFLATION LUMEN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6775556 ↗