Spirit® Hydrocolloid Adhesive Sheath 35303Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741070945), received between Jan 8, 2018 and Aug 25, 2025 — classified as 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (21 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SAID PATIENT WAS NO LONGER USING THE MALE EXTERNAL CATHETER DUE TO URINARY TRACT INFECTIONS. DID NOT SPECIFICALLY SAY ITEM CAUSED URINARY TRACT INFECTIONS. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22884290 ↗
• MalfunctionDec 4, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON ATTEMPTING TO INSERT THE TEMPERATURE SENSING FOLEY CATHETER INTO THE PATIENT, UPON CHECKING THE BALLOON, THE BALLOON WAS FOUND DEFECTIVE. IT WOULD INFLATE BUT WOULD NOT DEFLATE TO INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257926 ↗
• MalfunctionMar 13, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE DIFFICULT TO REMOVE AS THE ADHESIVE WOULD NOT LET GO AND CAUSED SEVERE IRRITATION WHEN IT REMOVED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16529293 ↗
• MalfunctionJan 3, 2023Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT 5 OF 30 MALE EXTERNAL CATHETERS HAD VERY LITTLE ADHESIVE AND WOULD NOT STICK OR HAD SO MUCH ADHESIVE AND BEEN GLUED TOGETHER AND IT DID NOT ALLOW THE CATHETER TO ROLL ONTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088375 ↗
• MalfunctionJan 2, 2023Inadequate Instructions for Healthcare Professional; Wrong Label; Inadequate Instructions for Healthcare Professional; Wrong Label

  IT WAS REPORTED THAT THE THERE WAS A LABEL DEFECT IN THE MALE EXTERNAL CATHETER, THE SMALLEST NOTES. INDICATES SPIRIT MODEL 1 25MM BT30 PENIEN CASE WHILE IT WAS THE 32MM MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16084167 ↗
• MalfunctionAug 9, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE IF THE PATIENT LAID THERE AND DRINK WATER, IT START FILLING UP THEN THE MALE EXTERNAL CATHETER WOULD FALL OFF. PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS (BATCH# JUFW0493). PER INVESTIGATOR NOTIFICATION RECEIVED ON 17FEB2022. IT WAS STATED THAT THE THREE LOTS WERE RECEIVED FOR THIS COMPLAINT: (BATCH# JUFU2520), (BATCH# JUFW1132) AND (BATCH# JUFV9017) PER NOTIFICATION FROM INVESTIGATOR BASED ON SAMPLE EVALUATION ON 26JUL2022, IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD STRONG ADHESIVE (BATCH# JUFW1132).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192558 ↗
• MalfunctionMay 20, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DRY ROTTED, OLD AND STUCK TO THEIR FINGERS AND DID NOT WANT TO ROLL. ALSO STATED THAT IT WAS YELLOWING AROUND THE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459723 ↗
• MalfunctionMar 29, 2022Nonstandard Device; Inadequacy of Device Shape and/or Size; Nonstandard Device; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD ADHESION AND RETRACTION PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13944058 ↗
• InjuryFeb 22, 2022Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER CAUSED URINARY TRACT INFECTION AND THE DOCTOR TOOK THE PATIENT OFF IT. THE PATIENT WAS NO LONGER USING IT. THE PATIENT HAD BEEN USING THIS PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 13577582 ↗
• MalfunctionFeb 17, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH GLUE. THE PATIENT HAD BEEN USING THIS PRODUCT FOR MORE THAN 90 DAYS. PER ADDITIONAL INFORMATION RECEIVED VIA FOLLOW-UP ON (B)(6) 2022, PATIENT STATED THAT BECAUSE OF THE ADHESIVE IT TOOK A LONG TIME (20-30 MINUTES) TO REMOVE THE EXTERNAL. PATIENT ALSO STATED THAT THEY HAD USED SOAP AND WATER BUT IT DID NOT WORK WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553029 ↗
• MalfunctionDec 30, 2021Inadequate or Insufficient Training; Device Handling Problem; Inadequate or Insufficient Training; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT DID NOT KNOW HOW TO REMOVE THE MALE EXTERNAL CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120365 ↗
• MalfunctionDec 26, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD A DIFFICULT TIME WHILE REMOVING THE ADHESIVE. IT WAS ALSO STATED THAT THE 3 MM WAS TOO BIG WHILE USING THE MALE EXTERNAL CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 17FEB2022, CUSTOMER STATED THAT WHEN REMOVING THE FREEDOM CLEAR 31MM CATHETERS, ADHESIVE REMAINS ON THE SKIN. ALSO STATED THAT EVEN AFTER WASHING WITH MILD SOAP AND WATER, AND USING A CREAM CUSTOMER WOULD STILL EXPERIENCE ADHESIVE RESIDUE ON THE SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085700 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO REMOVE THE MALE EXTERNAL CATHETER. THE PATIENT SENT ALL THREE OF THE EXTERNALS, BUT THE PATIENT DID NOT INDICATE WHICH ONE SPECIFICALLY HAD AN ISSUE OR WHETHER IT WAS MULTIPLE CATHETERS FROM THE ORDER. THE LIBERATOR REPRESENTATIVE RECOMMENDED THE PATIENT TO USE A WARM CLOTH TO HELP WITH THE REMOVAL. ALSO SUGGESTED THAT THE PATIENT COULD USE REMOVER WIPES IF THE WARM CLOTH DID NOT HELP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778187 ↗
• MalfunctionOct 13, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT ONE OF THE MALE EXTERNAL CATHETERS WERE INCORRECTLY PACKAGED AND THE ADHESIVE WAS ON THE PACKAGING. ALSO STATED THAT THERE WAS NO DIRECTION FOR THE ITEMS. THE COMPLAINANT STATED THAT ONE CATHETER OF 32 MM WAS REMAINING, AND THEY WOULD TRY IT. THE REPRESENTATIVE SENT A LINK FOR AN INSTRUCTION VIDEO ON MALE EXTERNAL CATHETERS. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. PER CUSTOMER CONTACT VIA PHONE ON 11NOV2021, IT WAS STATED THAT THERE WERE NO DIRECTIONS ON HOW TO USE THE MALE EXTERNAL CATHETERS AND THERE WAS NO MEASUREMENT TOOL. AS A NEW USER, THEY NEEDED THIS AND IT WAS LATER STATED THAT THEY WERE OFFERED A LINK TO A VIDEO THAT EXPLAINED THINGS. PER FOLLOW-UP VIA PHONE ON 17NOV2021 , CUSTOMER STATED ABOUT THE SIZING GUIDE USED FOR MEASURING THE PENIS WHEN ORDERING CONDOM CATHETERS BUT PATIENT DID NOT HAVE A SIZING GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624484 ↗
• MalfunctionAug 6, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS LEAKING AND THE PATIENT DID NOT PROVIDE FURTHER DETAILS. PER FOLLOW UP VIA PHONE ON 15JUL2021, IT WAS REPORTED THAT THE FIRST BOX OF MALE EXTERNAL CATHETERS DID NOT HAVE ANY INSTRUCTIONS AND THEY CALLED TO GET HELP WITH INSTRUCTIONS. THE SECOND BOX THEY RECEIVED HAD INSTRUCTIONS RIGHT ON TOP, THEY INDICATED WASHING THE PENIS PRIOR TO USE DUE TO OILS ON THE BODY, AND THEY HAVE NOT HAD THE PROBLEMS WITH LEAKING SINCE THEY STARTED WASHING THE PENIS PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292074 ↗
• MalfunctionJul 25, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS (MEC) DID NOT COME WITH THE REMOVAL INSTRUCTIONS. THE PATIENT STATED THAT THE MEC DID NOT STAY ON AND WHEN THE PATIENT USED FOR THE FIRST TIME, THE ADHESIVE GOT OVER EVERYWHERE AND ALL OVER THE HANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222977 ↗
• MalfunctionJun 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS VERY DIFFICULT TO REMOVE DUE TO THE ADHESIVE BEING SO STRONG. REPRESENTATIVE ADVISED PATIENT TO USE A WARM WET CLOTH AROUND THE PENIS TO LOOSEN THE ADHESIVE BEFORE TRYING TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958089 ↗
• InjuryApr 1, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF USING MALE EXTERNAL CATHETERS THAT RESULTED IN A URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11603103 ↗
• MalfunctionMar 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HURT THE PATIENT BECAUSE OF THE ADHESIVE. NO DETAILS WERE PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 11447292 ↗
• MalfunctionNov 3, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE AND UPON REMOVAL, IT WAS CAUSING SKIN TEARS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779423 ↗
• MalfunctionOct 26, 2020Nonstandard 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 10733689 ↗
• MalfunctionJun 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE URINE BACKED UP WHERE THE EXTERNAL FUNNELS DOWN. THE PATIENT ALSO STATED THAT SOME OF THE CATHETER TUBE WAS THICKER AND SOME WAS THINNER AND THE CATHETER WAS VERY HARD TO GET THE ADHESIVE OFF OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191154 ↗
• MalfunctionMay 27, 2020Nonstandard Device; Nonstandard Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE CUNNINGHAM CLAMP SHOULD BE MORE CIRCULAR AS IT CAUSED PAIN TO THE PATIENT AND THE EXTERNAL CATHETERS WERE HARD TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 10093748 ↗
• MalfunctionSep 4, 2019Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG, CAUSING THE MECS TO BE DIFFICULT TO REMOVE.

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

  MAUDE report 8961873 ↗
• InjuryJun 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION AND HEMATURIA WHILE USING THE MALE EXTERNAL CATHETER. TREATMENT PROVIDED IS UNKNOWN.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 8728077 ↗