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Catheter Stylet 004036Recalls & reported problems

C. R. Bard, Inc. · Catheter Stylet · Class 1

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 00801741049040), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 4, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT THE THE FOLEY CATHETER STYLET WAS BROKEN WHILE BEING USED. THE CUSTOMER STATED THAT THE YEAR OF MANUFACTURE WAS UNKNOWN, BUT IT WAS SOME YEARS OLD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12568096 ↗

Other STYLET FOR CATHETER, GASTRO-UROLOGY devices

All STYLET FOR CATHETER, GASTRO-UROLOGY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.