Clear Advantage Spirit Adhesive Sheath 7323Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741071652), received between Aug 24, 2017 and Dec 22, 2023 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER SHEATHS WERE COMING OFF AT THE BASE OF THE PENIS AND THAT AREA HAD ALSO BEEN GETTING A BIT SORE. SOMETIMES THE WHOLE PENIS HAD BEEN SORE, AND THE GENERAL PRACTITIONER PRESCRIBED A CREAM. THE SHEATHS WERE NOT USED WHILE SORE AND CONFIRMED THAT THE AREA WAS COMPLETELY DRY. THE PATIENT WAS USING A SIMPLE SOAP AND WAS SUGGESTED IMPERIAL LEATHER. THEY WERE NOT USING WET WIPES AND WERE ADVISED TO USE DRY WIPES AND KITCHEN TOWELS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18382771 ↗
• MalfunctionDec 27, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD NOTICED A CHANGE IN THE PACKAGING OF THEIR SHEATH. THE WHITE PLASTIC WAS A LOT THINNER AND ON THE CLEAR PLASTIC SIDE IT WAS VERY THIN AND VACUUM WAS PACKED AROUND THE SHEATH. THEY ALSO FELT THAT THE SHEATH ITSELF WAS INFERIOR TO WHAT THEY HAD BEEN USING WITH AND WERE COMING OFF MORE FREQUENTLY. AS PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2022, STATED THAT THE STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052462 ↗
• MalfunctionMay 23, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THIS BATCH OF MALE EXTERNAL SHEATHS SEEMED TO HAVE MORE ADHESIVE THAN USUAL AND WERE HARD TO TAKE OFF. AS PER THE FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 17MAY2022, IT WAS STATED THAT THERE WAS NO IMPACT TO THE PATIENT AND IT WAS JUST HARDER TO TAKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473917 ↗
• MalfunctionMar 10, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT WHEN THE MALE EXTERNAL SHEATHS WERE TAKEN OUT OF BOX, THE GLUE WAS CONGEALED AND SHEATHS SEEMED UNUSABLE. IT WAS ALSO STATED THAT THE SHEATHS FROM THE SAME LOT WERE KEPT ON POPPING OFF AT NIGHT AND HAD TO PUT ON 4 NEW SHEATHS AS THEY WOULD NOT STAY ON. PER FOLLOW UP VIA IBC ON 22FEB2022, THE SHEATHS WERE STUCK TO THEMSELVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721125 ↗
• MalfunctionAug 24, 2017Detachment Of Device Component; Product Quality Problem

  IT WAS REPORTED THAT THE SHEATHS KEPT COMING OFF. THE PATIENT'S WIFE STATED THERE WAS EITHER TOO MUCH OR NOT ENOUGH GLUE. THE CATHETER KEPT FALLING OFF NEAR WHERE THE LEG BAG WAS ATTACHED. THIS COMPLAINT IS OPENED TO ADDRESS THE "TOO MUCH GLUE" ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818718 ↗