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Bard® Center Entry Foley Tray with Bardex® All Silicone Foley Catheter 897414Recalls & reported problems

C. R. Bard, Inc. · Bard® Center Entry Foley Tray with Bardex® All Silicone Foley Catheter · 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 00801741020285), received between Oct 2, 2018 and Oct 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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

  • Obstruction of Flow1
  • Restricted Flow rate1

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.

  • MalfunctionOct 2, 2018Restricted Flow rate; Obstruction of Flow; Restricted Flow rate

    IT WAS REPORTED THAT THE REFLUX CHAMBER BECAME CLOGGED AND CAUSED URINE TO BACKFLOW INTO THE CATHETER.

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

    MAUDE report 7926374 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

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