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Pop-On™ Self-Adhering Male External Catheter 32304Recalls & reported problems

C. R. Bard, Inc. · Pop-On™ Self-Adhering Male External Catheter · Class 1

All models of Pop-On Self-Adhering Male External Catheter (9)

Data updated Oct 18, 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 00801741070587), received between Apr 23, 2019 and Apr 23, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1
  • Nonstandard Device1

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.

  • MalfunctionApr 23, 2019Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE.

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

    MAUDE report 8540462 ↗

Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices

All DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices →

Sources and updates

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