Clear Advantage Spirit Adhesive Sheath 7243Recalls & reported problems
C. R. Bard, Inc. · Clear Advantage Spirit Hydrocolloid Adhesive Sheath · Class 1
All models of Clear Advantage Spirit Adhesive Sheath (6)
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 00801741071638), received between Dec 11, 2017 and Dec 12, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component2
- Failure To Adhere Or Bond2
- Device Operates Differently Than Expected1
- Product Quality Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Product Quality Problem
IT WAS REPORTED THAT THE SHEATHS HAD AN INSUFFICIENT AMOUNT OF ADHESIVE ON THEM WHICH CAUSED THEM TO COME OFF DURING THE NIGHT. DURING SAMPLE EVALUATION, LOTS WERE FOUND TO HAVE STRONG ADHESION.
Patient problems: No Information
MAUDE report 7107622 ↗MalfunctionDec 12, 2017Failure To Adhere Or Bond
IT WAS REPORTED THAT THE SHEATHS HAD AN INSUFFICIENT AMOUNT OF ADHESIVE ON THEM WHICH CAUSED THEM TO COME OFF DURING THE NIGHT. DURING SAMPLE EVALUATION, LOTS WERE FOUND TO HAVE STRONG ADHESION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7107618 ↗MalfunctionDec 11, 2017Detachment Of Device Component; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE SHEATHS HAD AN INSUFFICIENT AMOUNT OF ADHESIVE ON THEM WHICH CAUSED THEM TO COME OFF DURING THE NIGHT. DURING SAMPLE EVALUATION, LOTS WERE FOUND TO HAVE STRONG ADHESION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7107277 ↗
Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices
- Spirit® Hydrocolloid Adhesive Sheath 39302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE48 reports
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- 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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