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Bardex® I.C. CritiCore® Foley Tray Bardex® Temperature-Sensing Foley Catheter 901216Recalls & reported problems

C. R. Bard, Inc. · Bardex® I.C. CritiCore® Foley Tray Bardex® Temperature-Sensing Foley Catheter · 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 00801741019562), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 15, 2017Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT HAIR WAS FOUND IN THE SYRINGE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7034081 ↗

Other CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices

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Sources and updates

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