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Clear Advantage Spirit Adhesive Sheath 5243Recalls & 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
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 00801741071560), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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

  • Nonstandard Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 21, 2021Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT PATIENT ORDERED MALE EXTERNAL CATHETERS WHICH WERE FAULTY, AS IT WAS ROLLING THEM ON THEY KEPT GETTING CRUMPLED UP, CAUSING AIR BUBBLES ON ONE SIDE AND THEN HAD A DIFFICULT TIME REMOVING THEM WITH THE ADHESIVE REMOVER SPRAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12035464 ↗

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

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

Sources and updates

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