Wideband Self-Adhering Male External CatheterRecalls & reported problems across all models

We found 9 models of Wideband Self-Adhering Male External Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between May 26, 2017 and Nov 10, 2025 — classified as 29 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (55 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 Wideband Self-Adhering Male External Catheter problems

Wideband Self-Adhering Male External Catheter models

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

• Wideband™ Self-Adhering Male External Catheter 36302

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  29 reports
• Wideband™ Self-Adhering Male External Catheter 36304

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  18 reports
• Wideband™ Self-Adhering Male External Catheter 36303

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  16 reports
• Wideband™ Self-Adhering Male External Catheter 36101

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  10 reports
• Wideband™ Self-Adhering Male External Catheter 36103

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  10 reports
• Wideband™ Self-Adhering Male External Catheter 36104

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  10 reports
• Wideband™ Self-Adhering Male External Catheter 36301

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  8 reports
• Wideband™ Self-Adhering Male External Catheter 36102

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  6 reports
• Wideband™ Self-Adhering Male External Catheter 36105

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

Recent Wideband Self-Adhering Male External Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE WOUND CARE NURSE AT THE (B)(6) CENTER. THEY CURRENTLY RECEIVED BD CONDOM CATHETERS FROM THEIR DISTRIBUTORS FOR USE ON THEIR VETERANS BUT DO NOT SEEM TO HAVE SIZERS FOR PROPER MEASURING TO APPLY THE CORRECT SIZE PER PATIENT. THEY HAVE BEEN EXPERIENCING AN INCREASE IN THE NUMBER OF MEDICAL DEVICE RELATED PRESSURE INJURIES LATELY WITH THE USE OF CONDOM CATHETERS AND BELIEVE IT WAS IN RELATION TO NOT SECURING TO CORRECT SIZE. NO MEDICAL INTERVENTION WAS REPORTED. CUSTOMER EMAIL RESPONSE RECEIVED ON 04NOV2025. IT WAS REPORTED THAT, "THE LOT NUMBERS FOR THE CONDOM CATHETERS THAT WERE USED MOST OFTEN ARE AS FOLLOWS: 29MM REF 36102 LOT NUMBER: JUKQ1552, 25MM REF 36101 LOT NUMBER: JUKV1982. THERE WERE NO DEFECTS IN THE PRODUCTS. CUSTOMER CAN ATTRIBUTE THE MINOR SKIN INJURIES TO USE OF THE INCORRECT SIZE DEVICE FOR SELECTED PATIENTS. IT WAS BROUGHT TO CUSTOMER'S ATTENTION THAT THE NURSING STAFF WERE NOT PROVIDED WITH ACCURATE SIZING GUIDES TO ASSIST THEIR CHOICES. THESE INJURIES WERE CHARACTERIZED AS MEDICAL DEVICE RELATED PRESSURE INJURIES FOR PATIENTS, NOW HEALED AND LONG DISCHARGED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23518896 ↗
• InjurySep 17, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE WOUND CARE NURSE AT THE (B)(6) MEDICAL CENTER. THEY CURRENTLY RECEIVED BD CONDOM CATHETERS FROM THEIR DISTRIBUTORS FOR USE ON THEIR VETERANS BUT DO NOT SEEM TO HAVE SIZERS FOR PROPER MEASURING TO APPLY THE CORRECT SIZE PER PATIENT. THEY HAVE BEEN EXPERIENCING AN INCREASE IN THE NUMBER OF MEDICAL DEVICE RELATED PRESSURE INJURIES LATELY WITH THE USE OF CONDOM CATHETERS AND BELIEVE IT WAS IN RELATION TO NOT SECURING TO CORRECT SIZE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23075274 ↗
• InjuryDec 30, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE 10 MALE EXTERNAL CATHETER29MM, MEDIUM, ROCHESTER, EXTRA ADHESIVE PURCHASED THIS ITEM AND WAS EXTERNAL CONDOM CATHETER FOR URINE DRAINAGE. AFTER THE CATHETER WAS INSERTED INTO THE PENIS, IT TOOK ALMOST 4 HOURS TO REMOVE THE PRODUCT. IT WAS VERY STICKY. NO WARNING OR INSTRUCTION TO REMOVE WERE GIVEN ON THE WEBSITE WHICH ADVERTISED THE PRODUCT. IT CAUSED INJURY TO THE PENIS, INCLUDING BLEEDING WHILE TRYING TO REMOVE IT. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 12DEC2024, STATED THAT AFTER INSERTING THE CATHETER, IT REMAINED IN PLACE FOR A DURATION OF 12 HOURS. WHEN THEY ATTEMPTED TO REMOVE IT, THEY ENCOUNTERED SIGNIFICANT DIFFICULTY. THE CATHETER ADHERED STRONGLY TO THE SKIN AND FOUND THAT THEY COULD NOT DETACH IT QUICKLY OR EASILY. IN FACT, THE PROCESS OF REMOVAL TOOK NEARLY TWO HOURS, DURING WHICH THEY HAD TO BE EXTREMELY CAUTIOUS TO AVOID CAUSING FURTHER DISCOMFORT. AS THEY SLOWLY WORKED TO PEEL IT AWAY, THEY NOTICED THAT THE ADHESIVE WAS EXCESSIVELY STICKY, LEADING TO IRRITATION OF THE SKIN ON THE PENIS. UNFORTUNATELY, THIS RESULTED IN INJURY AND SUBSEQUENT BLEEDING FROM THE SITE OF INJURY. IT TOOK ALMOST A WEEK FOR THE INJURY SITE TO HEAL AND TOPIC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation

  MAUDE report 21036924 ↗
• InjuryOct 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER GAVE THE PATIENT BLISTERS. PATIENT SOUGHT MEDICAL ATTENTION. PER FOLLOW UP ON (B)(6) 2023, PATIENT WAS GIVEN A PRESCRIPTION CREAM FOR THE REACTION.

  Patient problems: Blister

  MAUDE report 17912847 ↗
• MalfunctionJul 28, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE GLUE SUBSTANCE WAS STUCK TO APPLICATION AREA, CAUSING RAW SKIN AND WAS UNCOMFORTING. NO MEDICAL INTERVENTION WAS REPORTED. AS PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT PATIENT'S PROSTATE WAS REMOVED TWO MONTHS AGO. THE BATCH OF MALE EXTERNAL CATHETERS THEY RECEIVED HAD FAR TOO MUCH ADHESIVE TO THE POINT WHERE THEY HAD TO USE SCISSORS TO GENTLY CUT AWAY ANY RESIDUAL RESIDUE. THEY USED RUBBING ALCOHOL AS WELL, BUT IT DID LITTLE TO RESOLVE THE ISSUE.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 17413706 ↗
• InjuryJun 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS GETTING A RASH ON HIS PENIS, WENT TO THE DOCTOR AND GAVE MEDICATION AND IT IS CLEARING UP.

  Patient problems: Rash

  MAUDE report 17152438 ↗
• MalfunctionMay 22, 2023Inaccurate Flow Rate; Material Twisted/Bent; Inaccurate Flow Rate; Material Twisted/Bent

  IT WAS REPORTED, THAT THE PATIENT WAS HAVING ISSUES WITH THE URINE FLOWS SLOWLY DOWN TUBING IN MALE EXTERNAL CATHETER. PATIENT SAID, THAT IT COULD BE, DUE TO BENT OR KINK IN TUBING, SEDIMENT OR HOW THE BODY WAS RELEASING URINE SLOWER, BUT NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975970 ↗
• InjuryMay 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE ON THE MALE EXTERNAL CATHETERS. THE CUSTOMER HAD TWO BOXES OF CATHETERS (BATCH# JUGT1701 AND BATCH# JUGU9119). ON (B)(6) 2022, THE CUSTOMER STATED THAT THE BOX OF CATHETERS WERE NOT WORKING AND THEY KEPT COMING OFF. THE CUSTOMER STATED THAT THEY HAD TO CHANGE THE CATHETERS FOUR TIMES BECAUSE THEY KEPT COMING OFF. SO THE REPRESENTATIVE RECOMMENDED TO USE THE PRODUCT FROM THE BOTTOM OF THE BOX AS THE TOP PRODUCT MIGHT BE DEFECTIVE ON (B)(6) 2022. ON (B)(6) 2022, THE CUSTOMER STATED THAT THEY PICKED THE CATHETERS FROM THE BOTTOM AS RECOMMENDED BY REPRESENTATIVE. HOWEVER, THE CUSTOMER HAD TO CHANGE 2 CATHETERS AS THEY WERE STILL COMING OFF AND THE PATIENT WAS GETTING WET. ON (B)(6) 2022, THEY CUSTOMER STATED THAT THE PATIENT WAS NOT ABLE TO GET INTO THEIR CHAIR BECAUSE THEY KEPT GETTING WET AND HAD TO STAY IN BED. THE CUSTOMER COULD NOT GO OUT BECAUSE THEY HAD TO MAKE SURE TO KEEP CHANGING THE PATIENT'S CATHETER AND CLEAN THEM SO THAT THEY DO NOT GET INFECTIONS. THEY COULD NOT GO OUT BECAUSE THE CATHETERS KEPT LEAKING. AS PER FOLLOW-UP INFORMATION RECEIVED ON 27JAN2023, STATED THAT BOTH OF THE BOXES OF CONDOMS LEAKED

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16961147 ↗
• MalfunctionApr 24, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WOULD HOLD FOR UP TO ONE HOUR AND LATER WOULD FALL OFF. ALSO STATED THAT THE CATHETERS WERE STICKING. THE CUSTOMER REPLACED THE CATHETERS WITH A DIFFERENT LOT. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON (B)(6) 2023, IT WAS STATED THAT THE STRONG ADHESIVE THAT WAS FOUND DURING THE SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796739 ↗
• MalfunctionApr 20, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE AND THE PATIENT HAD ISSUES TRYING TO REMOVE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775752 ↗
• InjuryFeb 13, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE ON THE MALE EXTERNAL CATHETERS. THE CUSTOMER HAD TWO BOXES OF CATHETERS (BATCH#: JUGT1701 AND BATCH#: JUGU9119). ON 14DEC2022, THE CUSTOMER STATED THAT THE BOX OF CATHETERS WERE NOT WORKING AND THEY KEPT COMING OFF. THE CUSTOMER STATED THAT THEY HAD TO CHANGE THE CATHETERS FOUR TIMES BECAUSE THEY KEPT COMING OFF. SO THE REPRESENTATIVE RECOMMENDED TO USE THE PRODUCT FROM THE BOTTOM OF THE BOX AS THE TOP PRODUCT MIGHT BE DEFECTIVE ON 14DEC2022. ON 15DEC2022, THE CUSTOMER STATED THAT THEY PICKED THE CATHETERS FROM THE BOTTOM AS RECOMMENDED BY REPRESENTATIVE. HOWEVER, THE CUSTOMER HAD TO CHANGE 2 CATHETERS AS THEY WERE STILL COMING OFF AND THE PATIENT WAS GETTING WET. ON 18DEC2022, THE CUSTOMER STATED THAT THE PATIENT WAS NOT ABLE TO GET INTO THEIR CHAIR BECAUSE THEY KEPT GETTING WET AND HAD TO STAY IN BED. THE CUSTOMER COULD NOT GO OUT BECAUSE THEY HAD TO MAKE SURE TO KEEP CHANGING THE PATIENT'S CATHETER AND CLEAN THEM SO THAT THEY DO NOT GET INFECTIONS. THEY COULD NOT GO OUT BECAUSE THE CATHETERS KEPT LEAKING. PER FOLLOW-UP INFORMATION RECEIVED ON 27JAN2023, STATED THAT BOTH OF THE BOXES OF CONDOMS LEAKED. THE PATI

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16365175 ↗
• InjuryJan 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE ON THE MALE EXTERNAL CATHETERS AND INTERMITTENT CATHETERS. THE CUSTOMER HAD TWO BOXES OF CATHETERS (BATCH# JUGT2701 AND BATCH# JUGU9119). ON (B)(6) 2022, THE CUSTOMER STATED THAT THE BOX OF CATHETERS WERE NOT WORKING, AND THEY KEPT COMING OFF. THE CUSTOMER STATED THAT THEY HAD TO CHANGE THE CATHETERS FOUR TIMES BECAUSE THEY KEPT COMING OFF. SO THE REPRESENTATIVE RECOMMENDED USING THE PRODUCT FROM THE BOTTOM OF THE BOX AS THE TOP PRODUCT MIGHT BE DEFECTIVE ON (B)(6) 2022. ON (B)(6) 2022, THE CUSTOMER STATED THAT THEY PICKED THE CATHETERS FROM THE BOTTOM AS RECOMMENDED BY REPRESENTATIVE. HOWEVER, THE CUSTOMER HAD TO CHANGE 2 CATHETERS AS THEY WERE STILL COMING OFF, AND THE PATIENT WAS GETTING WET. ON (B)(6) 2022, THE CUSTOMER STATED THAT THE PATIENT WAS NOT ABLE TO GET INTO THEIR CHAIR BECAUSE THEY KEPT GETTING WET AND HAD TO STAY IN BED. THE CUSTOMER COULD NOT GO OUT BECAUSE THEY HAD TO MAKE SURE TO KEEP CHANGING THE PATIENT'S CATHETER AND CLEAN THEM SO THAT THEY DO NOT GET INFECTIONS. THEY COULD NOT GO OUT BECAUSE THE CATHETERS KEPT LEAKING. AS PER FOLLOW-UP INFORMATION RECEIVED ON 27JAN2023, STATED THAT BOTH OF

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 16272256 ↗
• MalfunctionJan 23, 2023Nonstandard Device; Insufficient Device Problem Information; Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE ADHESIVE STRENGTH OF THE CONDOM URINALS ADHERE ONLY BRIEFLY AND SLIP OFF WITH EVERY MOVEMENT. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 30NOV2022, STATED THAT THE PATIENT COMPLAINS ABOUT THE ADHESION AND THE LENGTH OF THE WEARING TIME TO INSUFFICIENT ADHESION. ALSO STATED THAT THERE WAS NO INFORMATION ON THE CONNECTION WITH A URINE BAG. BASED ON SAMPLE EVALUATION RECEIVED ON 12DEC2022, STATED THAT STRONG ADHESION WAS FOUND IN MALE EXTERNAL CATHETER. BASED ON SAMPLE EVALUATION RECEIVED ON 04JAN2023, STATED THAT STRONG ADHESION WAS FOUND IN MALE EXTERNAL CATHETER FOR THE ADDITIONAL SAMPLES RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223562 ↗
• MalfunctionDec 30, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT HAVE ENOUGH ADHESIVE AND FELL OFF IMMEDIATELY AFTER INSERTION. PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2022, IT WAS REPORTED THAT THE STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078135 ↗
• MalfunctionDec 28, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE ADHESIVE STRENGTH OF THE CONDOM URINALS ADHERE ONLY BRIEFLY AND SLIP OFF WITH EVERY MOVEMENT. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 30NOV2022, STATED THAT THE PATIENT COMPLAINS ABOUT THE ADHESION AND THE LENGTH OF THE WEARING TIME TO INSUFFICIENT ADHESION. ALSO STATED THAT THERE IS NO INFORMATION ON THE CONNECTION WITH A URINE BAG. BASED ON SAMPLE EVALUATION RECEIVED ON 12DEC2022, STATED THAT STRONG ADHESION WAS FOUND IN MALE EXTERNAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061092 ↗

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