Pop-On™ Self-Adhering Male External Catheter 32305Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741070600), received between Jun 6, 2019 and Aug 8, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Nonstandard Device2
- Difficult to Remove1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- Skin Tears1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUE WITH ADHESIVE ON MALE EXTERNAL CATHETERS AND REPRESENTATIVE GAVE SOME TROUBLE SHOOTING TIPS ON REMOVING ADHESIVE WITH WARM WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15185080 ↗MalfunctionAug 3, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS VERY HARD TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15160214 ↗MalfunctionDec 1, 2020Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE IN THE MALE EXTERNAL CATHETER AND TEARING SKIN. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Skin Tears
MAUDE report 10929264 ↗MalfunctionJun 6, 2019Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE MECS HAD TOO MUCH ADHESIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674788 ↗
Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices
- Spirit® Hydrocolloid Adhesive Sheath 39302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE48 reports
- Spirit® Hydrocolloid Adhesive Sheath 39303C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE42 reports
- Spirit® Hydrocolloid Adhesive Sheath 35302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE36 reports
- Spirit® Hydrocolloid Adhesive Sheath 35303C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE32 reports
- UltraFlex™ Self-Adhering Male External Catheter 33302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE31 reports
- Spirit® Hydrocolloid Adhesive Sheath 39304C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE29 reports
- Wideband™ Self-Adhering Male External Catheter 36302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE29 reports
- Spirit® Hydrocolloid Adhesive Sheath 35304C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE25 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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