Spirit® Hydrocolloid Adhesive Sheath 37302Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741071188), received between Apr 9, 2018 and Jun 28, 2024 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Loss of or Failure to Bond; Component Misassembled; Loss of or Failure to Bond; Component Misassembled

  IT WAS REPORTED THAT MALE EXTERNAL CATHETERS WERE NOT STAYING IN PLACE, CUSTOMER REPORTS THAT THEY ARE MISSING GLUE, THE BOTTOM HALF WAS MISSING. CUSTOMER HAS SORES FROM THE DEVICE COMING OFF AND BEING EXPOSED TO BODILY FLUID. CUSTOMER DOES HAVE NURSE TO COME IN TO TREAT WOUNDS. THEY HAD TO PURCHASE VENILAX TO TREAT THE SORES. CUSTOMER DID SEND IN URINALYSIS FOR FURTHER EVALUATION. PER CUSTOMER FOLLOW UP RECEIVED ON 26SEP2024, IT WAS REPORTED THAT THEY HAD BEEN USING THE SPIRIT CATHETERS FOR 18 YEARS AND THEY GOT A BAD BATCH EVERY SO OFTEN. CUSTOMER DESCRIBED THAT THE ADHESIVE WAS NOT SPREAD EVENLY THROUGHOUT THE CATHETER, AND IT DID NOT STAY ON FOR THE DESIGNATED, SPECIFIED AMOUNT OF TIME THAT IT SHOULD. THE BOTTOM HALF OF THE CATHETER WAS THE AREA WHERE THE ADHESIVE WAS NEEDED THE MOST, AND SOMETIMES WOULD HAVE ABSOLUTELY NO ADHESIVE. LOT NUMBER WAS ALREADY PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19632123 ↗
• MalfunctionMar 20, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE MADE IT DIFFICULT TO APPLY AND REMOVE THE MALE EXTERNAL CATHETER. THE PATIENT¿S HAIR GOT CAUGHT IN THE ADHESIVE CAUSING PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16578456 ↗
• MalfunctionSep 15, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE DID NOT REMOVE EASILY. THE REPRESENTATIVE ADVISED THAT THE PATIENT TO LET THE ADHESIVE BREAK DOWN TO AVOID DIFFICULT REMOVAL. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON 09SEP2022, NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427902 ↗
• MalfunctionJan 10, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS HARD TO TAKE OFF. THE REPRESENTATIVE WOULD LOOK TO HELP WITH THE REMOVAL OF THE CATHETER. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. PER CARDINAL HEALTH EMAIL RECEIVED ON 26DEC2021, IT WAS REPORTED THAT THE CUSTOMER HAD A HARD TIME REMOVING THE MALE EXTERNAL CATHETER DUE TO THE ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204583 ↗
• MalfunctionOct 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT TRIED USING A 29MM MALE EXTERNAL CATHETER AND IT GOT STUCK. THE PATIENT COULD NOT GET THE CATHETER OFF AND THOUGHT THAT THEY HAD TO GO TO THE EMERGENCY ROOM. ALSO STATED THAT THE PATIENT HAD PAIN IN THE PENIS FOR SEVERAL DAYS AFTER. THE MENTIONED CATALOG NUMBERS WERE 35302, 37302 AND 39302. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 12722453 ↗
• MalfunctionJul 19, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED IN MALE EXTERNAL CATHETER THE GLUE WOULDN'T COME OFF AND ALSO STATED THAT IT LITERALLY TOOK AN HOUR TO GET THE 29MM OFF. PATIENT SENT OTHER SIZES IN A SAMPLE ORDER TO TRY AND PREFERRED THE 36MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191595 ↗
• MalfunctionOct 20, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WERE TOO MUCH ADHESIVE ON CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10705745 ↗
• MalfunctionOct 20, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS HAVING TOO GLUE. AS PER THE FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 24SEP2020, THE PATIENT STATED THAT THE CATHETER WAS DIFFICULT TO REMOVE AND HAD WARM WASH CLOTH IN ORDER TO GET THE ADHESIVE OFF THE SKIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10703581 ↗
• MalfunctionSep 29, 2020Nonstandard Device; Therapeutic or Diagnostic Output Failure; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THE ADHESIVE OF THE MALE EXTERNAL CATHETER CHANGED AND WAS NOW STICKING TOO WELL.

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

  MAUDE report 10604073 ↗
• InjuryApr 27, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION FROM THE EXTERNAL CATHETERS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA PHONE ON 17APR2020, THE PATIENT WAS REPORTEDLY PRESCRIBED ANTIBIOTICS AND IT REPORTEDLY TOOK ABOUT A MONTH TO GET RID OF THE INFECTION.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 10001807 ↗
• MalfunctionMar 13, 2020Nonstandard Device; Patient-Device Incompatibility; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID THE SAMPLES SENT WERE TOO SMALL FOR HIM AND CAUSED SOME PAIN; AND, HE SAID THEY WERE PAINFUL TO REMOVE.

  Patient problems: Pain

  MAUDE report 9832231 ↗
• MalfunctionFeb 19, 2020Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETER, WHICH MADE IT DIFFICULT TO REMOVE THEM. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9727178 ↗
• MalfunctionNov 26, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378568 ↗
• MalfunctionAug 21, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON A FEW OF THE MALE EXTERNAL CATHETERS WAS TOO STICKY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8917317 ↗
• MalfunctionDec 10, 2018Nonstandard Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG.

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

  MAUDE report 8148703 ↗
• MalfunctionAug 8, 2018Inadequate Instructions for Healthcare Professional; Component Missing; Component Missing

  IT WAS REPORTED THAT THE CATHETER DID NOT COME WITH THE INSTRUCTIONS FOR USE.

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

  MAUDE report 7764603 ↗
• MalfunctionApr 9, 2018Nonstandard Device; Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS STRONG, THEREFORE IT WAS DIFFICULT TO REMOVE THE MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7408043 ↗