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Bardex® Silicone Coated Foley Catheter 0166V20SRecalls & reported problems

C. R. Bard, Inc. · Bardex® Foley Catheter 30cc 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741039515), received between Mar 7, 2021 and Mar 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (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

  • Decrease in Pressure1
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 9, 2021Decrease in Pressure; Decrease in Pressure

    IT WAS REPORTED THAT THE BALLOON DID NOT STAY INFLATED AND THE CATHETER CAME OUT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11446248 ↗
  • MalfunctionMar 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE CATHETER BALLOON FAILED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11429830 ↗

Other CATHETER, UROLOGICAL devices

All CATHETER, UROLOGICAL devices →

Sources and updates

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