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Bardex® Silicone Elastomer-Coated Foley Catheter Kit 710014SRecalls & reported problems

C. R. Bard, Inc. · Bardex® Silicone Elastomer-Coated Foley Catheter Kit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741046537), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Deflation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Deflation Problem1
  • Deformation Due to Compressive Stress1
  • Difficult to Remove1

Patient problems

  • 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.

  • InjuryAug 24, 2020Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT THE PATIENT HAD THE CATHETER AT THE HOSPITAL AND THE CATHETER COULD NOT BE DEFLATED AT ALL. THE CATHETER HAD SEEMED TO HAVE CURLED OVER OR KINKED INSIDE AND FAILED TO COME OUT. THIS CAUSED THE CATHETER TO BE SURGICALLY REMOVED AND IT WAS SO SEVERE THAT THE PATIENT HAD TO BE GIVEN A SUPRAPUBIC CATHETER PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10444601 ↗

Other CATHETER, COUDE devices

All CATHETER, COUDE devices →

Sources and updates

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