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Bard® Silastic® Foley Catheter 33428Recalls & reported problems

C. R. Bard, Inc. · Bard® Silastic® Foley Catheter 30cc Balloon · Class 2

All models of Bard Silastic Foley Catheter (13)

Data updated Oct 16, 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 00801741020049), received between Apr 21, 2017 and Jul 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 16, 2026.

Most reported problems

Device problems

  • Crack1
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE CLOSED PACKAGING OF THE FOLEY CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17379175 ↗
  • MalfunctionApr 21, 2017Crack

    IT WAS REPORTED THAT THE RUBBER WAS CRACKING AROUND THE RUBBER TUBING OF THE INFLATION PORT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6512977 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources and updates

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