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Bardex® Silicone Coated Foley Catheter 0165V28SRecalls & reported problems

C. R. Bard, Inc. · Bardex® Foley Catheter 5cc Balloon Silicone Coated · Class 2

All models of Bardex Silicone Coated Foley Catheter (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741039454), received between Jan 7, 2020 and Jan 7, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Device problems

  • Fluid/Blood Leak1
  • Patient-Device Incompatibility1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 7, 2020Fluid/Blood Leak; Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE OPENING SEVERAL MONTHS AFTER THE CATHETER WAS IN PLACE, AND WAS GIVEN AN OINTMENT TO APPLY. THE COMPLAINANT NOTED THAT WHEN THE INFECTION CLEARED UP, THEN THE CATHETER BEGAN TO LEAK.

    Patient problems: Unspecified Infection

    MAUDE report 9558385 ↗

Other CATHETER, COUDE devices

All CATHETER, COUDE devices →

Sources and updates

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