Spirit Hydrocolloid Adhesive SheathRecalls & reported problems across all models

We found 28 models of Spirit Hydrocolloid Adhesive Sheath by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 354 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2017 and Aug 25, 2025 — classified as 59 injuries, 295 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (239 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Spirit Hydrocolloid Adhesive Sheath problems

Spirit Hydrocolloid Adhesive Sheath models

28 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Spirit® Hydrocolloid Adhesive Sheath 39302

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  48 reports
• Spirit® Hydrocolloid Adhesive Sheath 39303

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  42 reports
• Spirit® Hydrocolloid Adhesive Sheath 35302

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  36 reports
• Spirit® Hydrocolloid Adhesive Sheath 35303

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  32 reports
• Spirit® Hydrocolloid Adhesive Sheath 39304

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  29 reports
• Spirit® Hydrocolloid Adhesive Sheath 35304

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  25 reports
• Spirit® Hydrocolloid Adhesive Sheath 37303

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  21 reports
• Spirit® Hydrocolloid Adhesive Sheath 37302

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  17 reports
• Spirit® Hydrocolloid Adhesive Sheath 35305

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  12 reports
• Spirit® Hydrocolloid Adhesive Sheath 39102

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  12 reports
• Spirit® Hydrocolloid Adhesive Sheath 35301

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  11 reports
• Spirit® Hydrocolloid Adhesive Sheath 37301

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  11 reports
• Spirit® Hydrocolloid Adhesive Sheath 37304

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  10 reports
• Spirit® Hydrocolloid Adhesive Sheath 39301

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  9 reports
• Spirit® Hydrocolloid Adhesive Sheath 39305

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  8 reports
• Spirit® Hydrocolloid Adhesive Sheath 37103

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  6 reports
• Spirit® Hydrocolloid Adhesive Sheath 35104

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  5 reports
• Spirit® Hydrocolloid Adhesive Sheath 35102

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  4 reports
• Spirit® Hydrocolloid Adhesive Sheath 35101

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  3 reports
• Spirit® Hydrocolloid Adhesive Sheath 35103

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  2 reports
• Spirit® Hydrocolloid Adhesive Sheath 37102

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  2 reports
• Spirit® Hydrocolloid Adhesive Sheath 39103

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  2 reports
• Spirit® Hydrocolloid Adhesive Sheath 39104

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  2 reports
• Spirit® Hydrocolloid Adhesive Sheath 35105

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report
• Spirit® Hydrocolloid Adhesive Sheath 37101

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report
• Spirit® Hydrocolloid Adhesive Sheath 37104

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report
• Spirit® Hydrocolloid Adhesive Sheath 37305

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report
• Spirit® Hydrocolloid Adhesive Sheath 39101

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report

Recent Spirit Hydrocolloid Adhesive Sheath adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT OVER THE LAST EIGHT MONTHS DEVELOPED SKIN IRRITATION. DID CONSULTED PRIMARY CARE PHYSICIAN WHO PRESCRIBED MEDICATION.

  Patient problems: Skin Inflammation/ Irritation; Tissue Breakdown; Urinary Tract Infection

  MAUDE report 22331771 ↗
• 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 ↗
• InjuryMay 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SPIRIT CONDOM MALE EXTERNAL CATHETER PATIENT HAD TO APPLY TAPE TO HOLD IT ON ALL NIGHT AND THAT WAS CAUSING IRRITATION WHEN REMOVED. PER ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER FOLLOW UP ON 07MAY2024, IT WAS REPORTED THAT SOME OF THE CATHETERS WOULD NOT STAY IN PLACE ONCE APPLIED. THEY ALSO CAUSE A BIT OF IRRITATION IN THE CUSTOMER'S PRIVATE AREA. CUSTOMER WAS PRESCRIBED AN ANTIBIOTIC CREAM TO APPLY IN THE AFFECTED AREA.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19392388 ↗
• 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 ↗
• MalfunctionJun 30, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE NOT SEALED PROPERLY AND WAS LEAKED . PER ADDITIONAL INFORMATION RECEIVED ON 13JUNE2023, IT WAS REPORTED THAT THE STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237139 ↗
• MalfunctionJun 14, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THESE MALE EXTERNAL CATHETERS CAUSED SORES ON TIP AND SHAFT OF PENIS. THE PATIENT STATED THAT THE ADHESIVE REMOVED THE SKIN OFF. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 17124782 ↗
• MalfunctionMay 31, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THESE MALE EXTERNAL CATHETERS WERE TOO STICKY AND VERY HARD TO GET OFF. PER FOLLOW UP VIA PHONE ON 05JUN2023, THE ADHESIVE WAS SO STRONG ON THE MALE EXTERNAL CATHETER THAT WHEN TRYING TO REMOVE THE FOLLOWING DAY, IT WOULD BE VERY DIFFICULT TO REMOVE. CUSTOMER STATED THAT SOMETIMES IT TOOK UP TO AN HOUR TO REMOVE ALL OF THE GLUE. ALSO STATED THAT IT ONLY HAPPENED WITH THE VERY LAST ORDER THEY RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031899 ↗
• InjuryMay 22, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINS IN THEIR KIDNEYS AND A BLADDER INFECTION AFTER TRYING THE INTERMITTENT CATHETER. IT WAS UNKNOWN IF THE DEVICE CAUSED THE BLADDER INFECTION AND UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE BLADDER INFECTION AT THIS TIME. PER FOLLOW UP VIA PHONE (B)(6) 2023, THEY RECEIVED CATHETERS THAT WERE TOO SMALL FOR THEIR ANATOMY THAT CAUSED AN INFECTION. THEY HAD SINCE RECEIVED BIGGER ONES THAT WORK MORE EFFECTIVELY. CUSTOMER WAS IN THE HOSPITAL FOR 3 DAYS AND RECEIVED ANTIBIOTICS FOR THE INFECTIONS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16973276 ↗
• InjuryMay 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THIS ISSUE HAS BEEN GOING ON FOR ABOUT THREE MONTHS AND THE PATIENT WAS STILL HAVING WHEN REMOVING. THE PATIENT¿S SKIN BECAME SENSITIVE AND IRRITATED. THE PATIENT STATED THAT THEIR DOCTOR GAVE A MATERIAL TO PUT ON THEIR PENIS FOR A COUPLE OF WEEKS AND NOW IT IS REALLY RED. THE PATIENT HAD BEEN USING A BLOW DRYER FOR THE PAST FIVE WEEKS TO KEEP THE CONDOM CATHETER ON. IT WAS STATED THAT THE PATIENT WAS THINKING THAT WITH WASHING, THEY WOULD BE OK.

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 16918222 ↗
• InjuryMay 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT USED SPIRIT CATHETERS AND BAGS. THE PATIENT WAS HOSPITALIZED WITH AN INFECTION AND HIGH FEVER AND URINARY TRACT INFECTION WITH BLOOD THEM URINE. THE CUSTOMER STATED WAS NOT SURE IF IT IS DUE TO CONDOM CATHETER, BUT THEY HAD ISSUES WITH CATHETERS TWISTING. THE HOSPITAL USING SOMETHING TO HOLD CATHETERS IN PLACE. THE REPRESENTATIVE LET CUSTOMER KNOW ASK WHAT THEY ARE USING. THE REPRESENTATIVE MIGHT BE USING A STAT LOCK AND PROVIDED PRICING. THERE WAS NO MENTION IF LOT INFORMATION WAS AVAILABLE. IT WAS UNKNOWN IF THE DEVICE CAUSED THE INFECTION AND UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION AT THIS TIME.

  Patient problems: Fever; Hematuria; Unspecified Infection; Urinary Tract Infection

  MAUDE report 16885462 ↗
• MalfunctionMay 4, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH FOUR MALE EXTERNAL CATHETER. THEY THAT HAD TOO MUCH ADHESIVE AND THE PATIENT COULD NOT GET THEM OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868028 ↗
• MalfunctionApr 26, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THEY WERE HARD TO REMOVE THE MALE EXTERNAL CATHETER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817912 ↗
• 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 ↗
• MalfunctionMar 16, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ALL OF 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 16551991 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports