Bardex® Lubri-Sil® All-Silicone Foley Catheter 176824Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741034251), received between Aug 19, 2021 and Aug 19, 2021 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BARDEX LUBRISIL FOLEY CATHETER HAD AN ISSUE BUT THE EXACT DEFECT WAS UNKNOWN. PER ADDITIONAL INFORMATION RECEIVED ON 28JUL2021 THE FOLEY CATHETER BALLOON WAS IN THE PATIENTS CERVIX FOR INDUCTION AND RUPTURED INSIDE THE UTERUS. WHEN THE CATHETER FELL OUT THE BALLOON WAS TORN. IT WAS NOTED THAT 30 CC WERE INFLATED INTO THE BALLOON AND NO MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER ANY MISSING PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344789 ↗