Clear Advantage Spirit Adhesive Sheath 7283Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741071645), received between Sep 5, 2017 and Mar 29, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER THOUGHT THAT THEY WERE DOING SOMETHING WRONG WHEN THEY WERE UNABLE TO CONNECT A BAG TO THE MALE EXTERNAL CATHETER. THE REPRESENTATIVE WENT TO HELP AND FOUND A FAULTY SHEATH. ONE OF THE MALE EXTERNAL CATHETER WAS FOUND TO BE HAVING THE OUTLET ON THE FUNNEL OF THE SHEATH CLOSED OFF. THE OUTLET SHOULD BE OPEN TO ALLOW URINE TO DRAIN. THEY CHECKED ALL OTHER SHEATHS IN THE BOX AND FOUND THAT OTHER SHEATHS WERE OKAY. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 22MAR2022, IT WAS STATED THAT THE DEFECT FOUND WHILE BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637405 ↗
• MalfunctionNov 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THIS PRODUCT WAS SO STICKY THAT IT LEFT PEELS OF ADHESIVE ON THE PATIENT'S SHEATH AREA, PLUS THE ROLL DOWN WAS INEFFECTIVE AT WRAPPING AROUND THE PENIS TO WORK PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752788 ↗
• MalfunctionDec 7, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS STRUGGLING TO GET THE MALE EXTERNAL CATHETER OFF AND STATED THERE WAS A FAULT WITH THE SHEATHS. IT WAS ALSO STATED THAT THE USER HAD THE SAME ISSUE WITH THE SAME PRODUCT AND LOT NUMBER WITH 2 DIFFERENT CUSTOMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10962228 ↗
• MalfunctionApr 3, 2020Leak/Splash; Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT SOME OF THE SHEATHS STUCK SO FAST, THAT THEY STRUGGLED TO REMOVE THEM EVEN WITH THE SPRAY AND WARM WATER. SHE WAS UNSURE WHY THIS HAPPENED, BUT SHE WAS UNCOMFORTABLE USING SO MUCH OF THE SPRAY AS SHE WAS CONCERNED WHAT IT WOULD DO TO THE PATIENTS' SKIN. IT WAS ALSO REPORTED THAT THE SHEATHS WERE ALSO COMING OFF, AND BARELY LASTED HALF THE NIGHT. IT WAS UNCLEAR IF IT WAS BECAUSE OF THE AMOUNT OF URINE THAT WAS FLOWING BACK FROM THE LEG BAG, AND THE PATIENT WONDERED IF IT COULD BE DISSOLVING THE ADHESIVE ON THE SHEATHS.

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

  MAUDE report 9923643 ↗
• MalfunctionDec 19, 2017Output above Specifications

  IT WAS REPORTED THAT DURING THE SAMPLE EVALUATION OF THE INVESTIGATION, TWO OF THOSE SAMPLES TESTED ABOVE SPECIFICATION FOR STRONG ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131921 ↗
• MalfunctionDec 18, 2017Output above Specifications

  IT WAS REPORTED THAT DURING THE SAMPLE EVALUATION OF THE INVESTIGATION, TWO OF THOSE SAMPLES TESTED ABOVE SPECIFICATION FOR STRONG ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127459 ↗
• MalfunctionSep 5, 2017Incorrect Measurement

  IT WAS REPORTED THAT THE ADHESIVE THE PATCH ON THE (CLEAR ADVANTAGE SPIRIT HYDROCOLLOID SHEATH STYLE 2 28MM) CATHETER IS NOT LONG ENOUGH COMPARED TO THE OTHER BATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6842606 ↗