Wideband™ Self-Adhering Male External Catheter 36303Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741071065), received between May 15, 2018 and Apr 20, 2023 — classified as 2 injuries, 14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 9, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE 90 PERCENTAGE OF MALE EXTERNAL CATHETERS WOULD NOT STICK. PATIENT STATED THAT ANY MOVEMENT WOULD MAKE THE CATHETERS PEEL OFF AND NO SENSE OF ADHESION AT ALL (LOT#JUFZ9068). PER ADDITIONAL INFORMATION FROM CARDINAL HEALTH, IT WAS REPORTED THAT ONE IN EVERY FEW OF THE MALE EXTERNAL CATHETERS WERE NOT STICKING DUE TO ADHESIVE. PER SAMPLE RECEIVED ON 18OCT2022, AN ADDITIONAL LOT WAS RETURNED LOT# JUFZ9067. PER INVESTIGATOR NOTIFICATION ON (B)(6) 2022, IT WAS REPORTED THAT STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION. THE AFFECTED LOTS WERE JUFZ9068 AND JUFZ9067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758552 ↗
• MalfunctionNov 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE 90 PERCENTAGE OF MALE EXTERNAL CATHETERS WOULD NOT STICK. PATIENT STATED THAT ANY MOVEMENT WOULD MAKE THE CATHETERS PEEL OFF AND NO SENSE OF ADHESION AT ALL (LOT#JUFZ9068). PER ADDITIONAL INFORMATION FROM CARDINAL HEALTH, IT WAS REPORTED THAT ONE IN EVERY FEW OF THE MALE EXTERNAL CATHETERS WERE NOT STICKING DUE TO ADHESIVE. PER SAMPLE RECEIVED ON 18OCT2022, AN ADDITIONAL LOT WAS RETURNED LOT# JUFZ9067. PER INVESTIGATOR NOTIFICATION ON 26OCT2022, IT WAS REPORTED THAT STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION. THE AFFECTED LOTS WERE JUFZ9068 AND JUFZ9067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752084 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING URINARY TRACT INFECTIONS AND WAS TOLD BY THE DOCTOR NOT TO USE EXTERNAL CATHETERS AT NIGHT AND THE DOCTOR THOUGHT IT WAS DUE TO THE MALE EXTERNAL CATHETERS, BUT THE PATIENT WAS STILL USING THEM . IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. AS PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAS HAD 2 URINARY TRACT INFECTIONS AND THE DOCTOR PRESCRIBED ANTIBIOTICS BOTH TIMES AND THE URINARY TRACT INFECTION CLEARED UP. ALSO THE DOCTOR RECOMMENDED THAT THE PATIENT NO LONGER USE THE MALE EXTERNAL CATHETER BUT THE PATIENT CHOSE TO USE THEM ANYWAY.

  Patient problems: Urinary Tract Infection

  MAUDE report 15486439 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING URINARY TRACT INFECTIONS AND WAS TOLD BY THE DOCTOR NOT TO USE EXTERNAL CATHETERS AT NIGHT AND THE DOCTOR THOUGHT IT WAS DUE TO THE MALE EXTERNAL CATHETERS, BUT THE PATIENT WAS STILL USING THEM . IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAS HAD 2 URINARY TRACT INFECTIONS AND THE DOCTOR PRESCRIBED ANTIBIOTICS BOTH TIMES AND THE URINARY TRACT INFECTION CLEARED UP. ALSO THE DOCTOR RECOMMENDED THAT THE PATIENT NO LONGER USE THE MALE EXTERNAL CATHETER BUT THE PATIENT CHOSE TO USE THEM ANYWAY.

  Patient problems: Urinary Tract Infection

  MAUDE report 15455694 ↗
• MalfunctionAug 2, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE 2 OR 3 MALE EXTERNAL CATHETERS HAD FALLEN OFF BECAUSE OF NOT ENOUGH ADHESIVE AND SOMETIMES THEY DID NOT ROLL DOWN RIGHT AND WOULD STICK TO ITSELF AND KNOT UP IF SOME HAVE TOO MUCH GLUE AND SOMETIMES THE PATIENT HAD LEAK IF THERE WAS NOT ENOUGH ADHESIVE ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152723 ↗
• MalfunctionFeb 22, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER CONDOMS NO LONGER HAD A TIGHT GRIP AND SLIPPED OFF. PER SAMPLE EVALUATION FROM INVESTIGATOR VIA EMAIL ON 31JAN2022, THE ADHESIVE WAS FOUND TO BE STRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578990 ↗
• MalfunctionApr 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SAMPLES OF THE MALE EXTERNAL CATHETERS WITH ADHESIVE WERE DIFFICULT TO REMOVE. PATIENT STATED THAT USING A SOAPY WATER DID NOT REALLY HELP WITH REMOVING THESE EXTERNALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607441 ↗
• MalfunctionDec 23, 2020Nonstandard Device; Nonstandard Device

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

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

  MAUDE report 11065387 ↗
• MalfunctionDec 4, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT CATHETERS LEFT SCARRING DUE TO ADHESIVE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 10950186 ↗
• MalfunctionSep 15, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE REMOVAL OF THE MALE EXTERNAL CATHETERS. THE PATIENT EXPERIENCED THE PAIN. ADVISED THE PATIENT TO USE THE WARM COMPRESSES BEFORE TRYING TO REMOVE THE CATHETER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 10536430 ↗
• MalfunctionAug 21, 2020Nonstandard Device; Material Integrity Problem; Nonstandard Device

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

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

  MAUDE report 10436473 ↗
• MalfunctionJul 10, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS EXTRA STICKY WHICH MADE IT DIFFICULT TO REMOVE THE CATHETER FROM THE PATIENT. THE PATIENT REPORTEDLY HAD TO USE COCONUT OIL AND DISH DETERGENT TO REMOVE THE CATHETER.

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

  MAUDE report 10259591 ↗
• MalfunctionMar 5, 2020Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER PEELED THE PATIENT'S SKIN OFF AND HE STOPPED USING THEM FOR A WHILE.

  Patient problems: Skin Tears; Tissue Damage

  MAUDE report 9794989 ↗
• MalfunctionAug 7, 2019Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE URINE SOMETIMES BACKS UP INTO THE CATHETER.

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

  MAUDE report 8870509 ↗
• MalfunctionMay 15, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Sticking; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER'S ADHESIVE WAS STRONG, AS A RESULT IT WAS DIFFICULT TO REMOVE THE CATHETER. IT WAS REPORTED THAT A WARM COMPRESS WAS USED TO TRY AND REMOVE THE MALE EXTERNAL CATHETER, HOWEVER THE CATHETER WAS STILL NOT COMING OFF. ALLEGEDLY IT TOOK 30 MINUTES TO REMOVE THE MALE EXTERNAL CATHETER AND SCISSORS HAD TO BE USED TO REMOVE THE CATHETER. ALLEGEDLY THE PATIENT ONLY CHANGED ON THE MALE EXTERNAL 2 TIMES A WEEK, WHEN THE INSTRUCTIONS STATE TO CHANGE THE CATHETER EVERY 24 HOURS.

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

  MAUDE report 7515115 ↗