Spirit® Hydrocolloid Adhesive Sheath 35304Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741070952), received between Mar 5, 2018 and Jun 22, 2022 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (18 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND THE DOCTOR TOLD THE PATIENT TO STOP USING THE MALE EXTERNAL CATHETERS. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND THE MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 14778410 ↗
• MalfunctionMar 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THE ADHESIVE OF THE MALE EXTERNAL CATHETER STICKING TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693758 ↗
• MalfunctionJan 17, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT HAVE DRAINAGE AND THE PATIENT WANTED TO SEND 23 BACK. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13271382 ↗
• MalfunctionDec 16, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WENT ON SMOOTHLY FOR THE PATIENT BUT HAD A REALLY HARD TIME IN THE MORNING WHILE TRYING TO REMOVE THE CATHETER. IT WAS NOTED THAT THE PATIENT HAS BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018094 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO REMOVE THE MALE EXTERNAL CATHETER. 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. 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 12778189 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO REMOVE THE MALE EXTERNAL CATHETER. 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. 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 12778188 ↗
• InjuryJun 8, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN URINARY TRACT INFECTION BECAUSE OF USING THE MALE EXTERNAL CATHETER. THE PATIENT ALSO HAD TROUBLE URINATING IF THE CATHETER WAS ON ALL NIGHT. IT WAS UNKNOWN THAT WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER CUSTOMER¿S RESPONSE VIA PHONE ON (B)(6) 2021, IT WAS STATED THAT THE PATIENT WAS CHANGED TO A DIFFERENT MALE EXTERNAL CATHETER AND A LARGER BAG WITH GOOD RESULTS. PATIENT ONLY HAD ONE URINARY TRACT INFECTION AND NO PROBLEMS SINCE.

  Patient problems: Urinary Tract Infection

  MAUDE report 11959195 ↗
• MalfunctionApr 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WENT DOWN TOO FAR AND THERE WAS TOO MUCH ADHESIVE. ALSO THE PATIENT SAID THAT THEY WERE USING CORN STARCH TO KEPT THE SPIRIT SHEATH MALE EXTERNAL CATHETER FROM STICKING SO TIGHT BECAUSE THE PATIENT HAD EXPERIENCED A LOT OF PAIN AND DISCOMFORT WHILE REMOVING IT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 11748496 ↗
• MalfunctionMar 17, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER SHEATH LEFT A LOT TO BE DESIRED. IT WAS VERY DIFFICULT TO REMOVE EVEN WITH WARM WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509918 ↗
• MalfunctionJan 6, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED THE ADHESIVE WAS SO STRONG AND THE MALE EXTERNAL CATHETER PULLED AWAY FROM ITSELF AND RIPPED OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11123933 ↗
• 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 10733693 ↗
• MalfunctionOct 13, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETER FROM THIS BOX. AS A RESULT THE PATIENT HAD A DIFFICULT TIME TAKING THEM OFF .IT CAUSED DISCOMFORT AND PAIN AND ALSO IT WAS IRRITATING THE SKIN. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Discomfort; Irritation; Pain

  MAUDE report 10674077 ↗
• MalfunctionSep 24, 2020Nonstandard Device; Product Quality Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD PEELED SKIN OFF WITH THE CONDOM CATHETER. THE PATIENT HAD A SORE NOW HENCE HAD TO QUIT USING FOR A WHILE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Injury; Pressure Sore/Ulcer

  MAUDE report 10580414 ↗
• MalfunctionSep 11, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THE ADHESIVE STICKING TOO MUCH.

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

  MAUDE report 10521569 ↗
• MalfunctionMay 13, 2020Nonstandard Device; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED BY THE PATIENT THAT ADHESIVE ON THE EXTERNALS WAS TOO STRONG, THE PATIENT SAID IT WAS DIFFICULT TO REMOVE THE EXTERNAL AND ALSO DIFFICULT TO REMOVE THE RESIDUE.

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

  MAUDE report 10051453 ↗
• InjuryFeb 25, 2020Obstruction of Flow; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE NOT UNROLLING ALL THE WAY, AND URINE WAS COLLECTING IN THE TIP AND NOT DRAINING PROPERLY. THE PATIENT ALLEGED THAT THE ISSUE CAUSED UTI'S (URINARY TRACT INFECTIONS). THE PATIENT WAS NOT TREATED BY A DOCTOR FOR A URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 9750554 ↗
• InjuryNov 5, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT STATED THE EXTERNAL 36 MM SPIRIT CATHETERS ALLEGEDLY CAUSED A URINARY TRACT INFECTIONS. HOWEVER, THERE WAS NO TREATMENT BY A MEDICAL DOCTOR, AND NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9280088 ↗
• MalfunctionSep 9, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A HARD TIME REMOVING THE EXTERNALS AS THERE WAS TOO MUCH ADHESIVE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976314 ↗
• MalfunctionJul 23, 2019Nonstandard Device; Nonstandard Device; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY REMOVING THE ADHESIVE FROM THE SPIRIT STYLE CATHETER. AS A RESULT THE PATIENT EXPERIENCED SKIN IRRITATION.

  Patient problems: Skin Irritation

  MAUDE report 8816145 ↗
• MalfunctionJun 5, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT FIRST FIVE CATHETERS IN THE PACKAGE WERE TOO STICKY. THE PATIENT STATED THAT WEATHER IN HIS AREA MAY HAVE CAUSED THE ISSUE AS THERE WAS MOISTURE IN THE PACKAGE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671425 ↗
• MalfunctionMay 31, 2019Nonstandard Device; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG ON THE MALE EXTERNAL CATHETER. THE PATIENT HAD ISSUES TRYING 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 8658367 ↗
• MalfunctionSep 10, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG. THE COMPLAINANT REPORTEDLY HAD TO CUT THE CATHETER WITH SCISSORS IN ORDER TO REMOVE IT.

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

  MAUDE report 7862064 ↗
• MalfunctionSep 6, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE CATHETER WAS TOO STRONG. THE PATIENT ALLEGEDLY EXPERIENCED SKIN TEARING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 7850188 ↗
• MalfunctionAug 17, 2018Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STRONG AND LED TO THE PATIENT EXPERIENCING DIFFICULTIES WITH REMOVAL. THE PATIENT ALLEGEDLY EXPERIENCED SKIN IRRITATION FOLLOWING REMOVAL OF THE MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Skin Irritation

  MAUDE report 7795787 ↗
• MalfunctionMar 5, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO UNROLL; THE CATHETER WOULD PULL ON THE SKIN AND LEAVE THE PENIS STICKY. THE COMPLAINANT ALLEGED THAT A WARM WASH CLOTH WAS USED BEFORE TRYING TO REMOVE AND IT WOULD NOT WORK. THE PATIENT EXPERIENCED PAIN AND DISCOMFORT WITH REMOVAL OF THE CATHETER. THE CATHETER WAS ALLEGEDLY IN PLACE FOR 12-24 HRS.

  Patient problems: Discomfort; Pain

  MAUDE report 7312742 ↗