Bardex® Malecot Model Drain 086012Recalls & reported problems
C. R. Bard, Inc. · Bardex® Malecot Drain Proportionate Head · Class 2
Data updated Oct 13, 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 00801741023828), received between Dec 17, 2019 and Dec 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
- Misassembled1
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionDec 17, 2019Misassembled; Misassembled; Material Puncture/Hole
IT WAS REPORTED THAT A PINHOLE WAS FOUND ON THE CONNECTION BETWEEN THE FUNNEL AND THE SHAFT OF THE CATHETER.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9484235 ↗
Other Catheter, malecot devices
- Bardex® Malecot Model Drain 086014C. R. Bard, Inc. · Catheter, malecot3 reports
- Bardex® Malecot Model Drain 086032C. R. Bard, Inc. · Catheter, malecot2 reports
- Bardex® Malecot Model Drain 086030C. R. Bard, Inc. · Catheter, malecot1 report
- Bardex® Malecot Model Drain 086034C. R. Bard, Inc. · Catheter, malecot1 report
- Bardex® Malecot Model Drain 086028C. R. Bard, Inc. · Catheter, malecot1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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