UltraFlex™ Self-Adhering Male External Catheter 33303Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741070778), received between May 26, 2017 and Sep 27, 2022 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GETTING URINARY TRACT INFECTIONS BUT WAS NOT SURE WHETHER IT WAS FROM THE CONDOM CATHETERS. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTIONS AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN. AS PER CUSTOMER VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT PATIENT DID HAVE AN URINARY TRACT INFECTIONS TWICE AND WAS PRESCRIBED ANTIBIOTICS TWICE FROM THEIR DOCTOR.

  Patient problems: Urinary Tract Infection

  MAUDE report 15494208 ↗
• MalfunctionOct 5, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE IN THE MALE EXTERNAL CATHETER WAS TOO AGGRESSIVE, AND IT SEEMED TO PULL AWAY THE SKIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 12576613 ↗
• InjurySep 29, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS ONGOING YEAST INFECTIONS AND NOT USING THE MALE EXTERNAL CATHETER. STATED THAT THE PATIENT ALSO USES ADULT DIAPERS FROM TIME TO TIME AND HAD CURRENTLY STOPPED THE USE OF BOTH. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE INFECTION AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Fungal Infection

  MAUDE report 10602367 ↗
• MalfunctionSep 29, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS TOO STRONG AND RIPPED THE PATIENT'S SKIN OFF. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion; Skin Tears

  MAUDE report 10600518 ↗
• MalfunctionSep 1, 2020Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE REMOVING THE EXTERNAL CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 10477669 ↗
• MalfunctionJun 5, 2020Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT CATHETER STUCK TOGETHER SOMETIMES AND THE PATIENT TOOK TIME TO GET THE CATHETER OFF. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 10122740 ↗
• MalfunctionMay 4, 2020Nonstandard Device; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE EXTERNALS WERE HARD TO REMOVE.

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

  MAUDE report 10021083 ↗
• MalfunctionMay 1, 2020Nonstandard Device; Nonstandard Device; Use of Device Problem

  IT WAS REPORTED THAT THE CATHETERS WERE PAINFUL TO REMOVE FROM THE PATIENT AND SHOULD COME WITH INSTRUCTIONS TO TRIM THE AREA.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 10018306 ↗
• MalfunctionMar 19, 2020Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED HE WAS HAVING INCONSISTENCY WITH THE EXTERNAL CATHETERS. SOME HAD EXTREMELY STRONG ADHESIVE, AND SOME JUST SLID RIGHT OFF IN THE EVENING TIME.

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

  MAUDE report 9853621 ↗
• MalfunctionMar 3, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS PAINFUL DURING REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 9780448 ↗
• MalfunctionJun 5, 2019Nonstandard Device; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG. THE PATIENT EXPERIENCED BRUISING WHILE REMOVING THE CATHETER; NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Bruise/Contusion

  MAUDE report 8672060 ↗
• InjuryMay 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN IRRITATION AND AN URINARY TRACT INFECTION.

  Patient problems: Skin Irritation; Urinary Tract Infection

  MAUDE report 8630680 ↗
• InjuryJul 23, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  THE PATIENT ALLEGEDLY DEVELOPED AN URINARY TRACT INFECTION WHILE USING THE CATHETER. AT THIS TIME IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Urinary Tract Infection

  MAUDE report 7712236 ↗
• MalfunctionMay 30, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTIES REMOVING THE MALE EXTERNAL CATHETER. THE PATIENT STATED THAT THE ADHESIVE REMAINED ON HIS SKIN. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7555688 ↗
• MalfunctionMar 26, 2018Nonstandard Device; Nonstandard Device; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETERS WERE TOO STRONG, WHICH MADE THEM DIFFICULT AND PAINFUL TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 7369861 ↗
• MalfunctionNov 26, 2017Component Missing

  IT WAS REPORTED THAT THE CUSTOMER COMPLAINED OF EMPTY POUCHES. INSIDE THE BOX WERE 6 PACKAGES WITHOUT A DEVICE INSIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7058311 ↗
• MalfunctionOct 11, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG.

  Patient problems: No Information

  MAUDE report 6939992 ↗
• MalfunctionOct 11, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6939895 ↗
• MalfunctionSep 19, 2017Product Quality Problem; Sticking

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS STICKIER THAN USUAL.

  Patient problems: No Information

  MAUDE report 6877157 ↗
• MalfunctionSep 14, 2017Difficult to Remove; Sticking

  IT WAS REPORTED THAT THE CONDOMS ADHERED TOO STRONG. GLUE REMAINED ON THE SKIN AND LED TO IRRITATIONS AND DEFECTS.

  Patient problems: Skin Irritation

  MAUDE report 6866900 ↗
• MalfunctionSep 12, 2017Product Quality Problem; Sticking

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

  Patient problems: No Information

  MAUDE report 6859293 ↗
• MalfunctionMay 26, 2017Difficult to Remove

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG. THE REMOVAL OF THE DEVICE WAS VERY PAINFUL, EVEN WITH THE ASSISTANCE OF WATER AND OTHER AIDS, AND ALLEGEDLY IRRITATED THE PATIENT'S SKIN.

  Patient problems: Adhesion(s); Pain

  MAUDE report 6593579 ↗