Natural™ Non-Adhesive Male External Catheter 38304Recalls & reported problems
C. R. Bard, Inc. · Natural™ Non-Adhesive Male External Catheter · Class 1
All models of Natural Non-Adhesive Male External Catheter (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741071256), received between Jan 6, 2021 and Apr 26, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Illegible Information1
- Inadequate Instructions for Healthcare Professional1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE HARD TO REMOVE, SOMETIMES IT GOT TIGHT ON THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14205300 ↗MalfunctionDec 29, 2021Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE OF MALE EXTERNAL CATHETERS WERE NOT CLEAR. THE PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13114985 ↗MalfunctionJan 6, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT THE LAST BOX OF THE CONDOM CATHETERS HAD ADHESIVE ON THEM, WHICH THEY WERE SUPPOSED TO BE NON-ADHESIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11124197 ↗
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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