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Bardex® Silicone Elastomer-Coated Foley Catheter Kit 710018SRecalls & reported problems

C. R. Bard, Inc. · Bardex® Silicone Elastomer-Coated Foley Catheter Kit · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741046551), received between Jun 18, 2019 and Jun 18, 2019 — 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

Device problems

  • Burst Container or Vessel1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Information1

Recent adverse event reports

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

  • MalfunctionJun 18, 2019Use of Device Problem; Burst Container or Vessel; Use of Device Problem

    IT WAS REPORTED THAT THE PATIENT NEEDED A BIGGER BALLOON (30 CC) SO THEY TRIED TO OVERFILL 5 CC AND IT BURST. THE FOLEY WAS REPLACED.

    Patient problems: No Consequences Or Impact To Patient; No Information

    MAUDE report 8708173 ↗

Other CATHETER, COUDE devices

All CATHETER, COUDE devices →

Sources and updates

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