Clear Advantage Spirit Adhesive Sheath 5323Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741071584), received between May 10, 2018 and Mar 16, 2023 — classified as 2 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE ROLLING UP AND CAUSING LEAKING. ALSO STATED THAT THEY WERE HAVING PROBLEMS TAKING THE SHEATHS OFF AS THEY WERE SO ADHESIVE AND WERE TOO STICKY. THE PATIENT STATED THAT THIS HAD RESULTED IN BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 16554295 ↗
• MalfunctionMay 10, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SHEATHS WERE COVERED IN TOO MUCH ADHESIVE SO MUCH SO THEY ARE DIFFICULT TO REMOVE AND ARE CAUSING DAMAGE TO THE PATIENT'S SKIN ON LEGS WHERE THEY TOUCH THE ADHESIVE. IT GETS ON THE PATIENTS CLOTHING AND THEY ARE MUCH MORE DIFFICULT TO UNROLL. PER ADDITIONAL INFORMATION THE SKIN WAS NOT DAMAGED.

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

  MAUDE report 7502651 ↗