Clear Advantage Male Continence Sheath 1283Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741070280), received between May 21, 2021 and Dec 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER ADVISED THE MALE EXTERNAL CATHETERS WERE NOT THE SAME QUALITY AS THEY WERE BEFORE. THE CUSTOMER STATED THAT MOST OF THE MALE EXTERNAL CATHETERS WERE VERY HARD TO ROLL AND SEEMED TO BE LOOKING LIKE THEY WERE STUCK ON THE EDGE, OR THE ADHESIVE HAD DRIED. SOME OF THEM WERE TOUGH AND SOME WERE SOFT. THE CUSTOMER WAS USING TWO SHEATHS A DAY BUT SOMETIMES THEY FORGOT TO CHANGE, AND ONE SHEATH LASTED UP TO 3 DAYS AND SOME OF THEM CAME OFF. THE CUSTOMER STATED THAT THEY HAD DONE EVERYTHING TO ENSURE THE SHEATH STAYS ON, BUT IT JUST UNROLLS. SOMETIMES, IT WAS QUITE HARD TO REMOVE SOME OF THE GLUE THAT WAS LEFT ON THE PENIS ONCE SHEATH WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968606 ↗
• MalfunctionAug 30, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SHEATHS OF THE MALE EXTERNAL CATHETER WERE LEAVING BEHIND EXCESS GLUE AND WERE DISINTEGRATING WHEN ADHESIVE REMOVER WAS USED. THE PATIENT STATED THAT IT TOOK 10 MINUTES TO CLEANLY REMOVE THE ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385682 ↗
• MalfunctionMay 21, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT FEW OF THE SHEATHS OF THE MALE EXTERNAL CATHETERS WERE TOO STICKY AND SO COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867336 ↗