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Bardex® Malecot Model Drain 086014Recalls & reported problems

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741023835), received between Dec 19, 2019 and Sep 29, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

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 Puncture/Hole2
  • Device Damaged Prior to Use1
  • Incorrect Measurement1
  • Manufacturing, Packaging or Shipping Problem1
  • Material Protrusion/Extrusion1
  • Misassembled1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2020Incorrect Measurement; Manufacturing, Packaging or Shipping Problem; Incorrect Measurement

    IT WAS REPORTED THAT IT CONTAINED THE DEVICE OF DIFFERENT HARDNESS. IT WAS ALSO STATED THAT THE WRONG SIZE WAS INCORRECTLY PACKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

    MAUDE report 10600515 ↗
  • MalfunctionJan 27, 2020Material Puncture/Hole; Device Damaged Prior to Use; Material Protrusion/Extrusion; Device Damaged Prior to Use

    IT WAS REPORTED THAT A PINHOLE WAS FOUND ON THE CONNECTION BETWEEN THE FUNNEL AND SHAFT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 4 JANUARY 2020 FROM THE INVESTIGATOR, THE MALECOT WAS NOT MADE NOR INTENDED TO HAVE A BALLOON. HOWEVER, A PINHOLE WAS FOUND ON THE DEVICE. PER SAMPLE EVALUATION, IT WAS FOUND THAT THERE WAS A PROTRUSION COMING FROM THE MALECOT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9634648 ↗
  • MalfunctionDec 19, 2019Misassembled; Misassembled; Material Puncture/Hole

    IT WAS REPORTED THAT A PINHOLE WAS FOUND ON THE CONNECTION BETWEEN THE FUNNEL AND SHAFT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9497547 ↗

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.