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Bardex® Malecot Model Drain 086028Recalls & reported problems

C. R. Bard, Inc. · Bardex® Malecot Drain Proportionate Head · Class 2

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 00801741023903), received between May 12, 2023 and May 12, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1

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.

  • MalfunctionMay 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL FOUND BEFORE USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16918431 ↗

Other Catheter, malecot devices

All Catheter, malecot devices →

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