UltraFlex™ Self-Adhering Male External Catheter 33103Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741070686), received between Apr 25, 2017 and Jan 3, 2023 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE STICKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086164 ↗
• MalfunctionMar 24, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER WAS TRYING OUT MALE EXTERNAL CATHETERS AND HAVE TRIED TWO TYPES BUT BOTH WERE INCONSISTENTLY STAYING IN PLACE THROUGH THE NIGHT. CUSTOMER MENTIONED THAT THEY HAVE STAYED ON 2 OUT OF 5 NIGHTS (LOT: JUFV2649 & LOT: JUFX2803). INQUIRER REVIEWED THE DIRECTION FOR USE WITH THE CUSTOMER AND FOUND THAT THEY WERE APPROPRIATELY APPLYING THE CATHETER. CUSTOMER REPORTED THAT THEY CLEANED THE PENIS WITH SOAP AND WATER, THOROUGHLY DRIED IT AND APPLIED THE CATHETER SO THAT IT HAD A LIMITED NUMBER OF WRINKLES AND TRIED TO SQUEEZE IT SO THAT THE ADHESIVE STUCK TO THE SKIN. CUSTOMER ALSO REPORTED THAT THE LARGER OF THE TWO CATHETERS SEEMED TO FIT THE PATIENT BETTER BUT SAID THAT IT EVEN CAME OFF AND ALSO NOTED THAT SOME CATHETERS SEEMED TO BE MORE STICKY THAN OTHERS (LOT: JUFV2649 & LOT: JUFX2803).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873490 ↗
• MalfunctionMar 24, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER WAS TRYING OUT MALE EXTERNAL CATHETERS AND HAVE TRIED TWO TYPES BUT BOTH WERE INCONSISTENTLY STAYING IN PLACE THROUGH THE NIGHT. CUSTOMER MENTIONED THAT THEY HAVE STAYED ON 2 OUT OF 5 NIGHTS (LOT: JUFV2649 & LOT: JUFX2803). INQUIRER REVIEWED THE DIRECTION FOR USE WITH THE CUSTOMER AND FOUND THAT THEY WERE APPROPRIATELY APPLYING THE CATHETER. CUSTOMER REPORTED THAT THEY CLEANED THE PENIS WITH SOAP AND WATER, THOROUGHLY DRIED IT AND APPLIED THE CATHETER SO THAT IT HAD A LIMITED NUMBER OF WRINKLES AND TRIED TO SQUEEZE IT SO THAT THE ADHESIVE STUCK TO THE SKIN. CUSTOMER ALSO REPORTED THAT THE LARGER OF THE TWO CATHETERS SEEMED TO FIT THE PATIENT BETTER BUT SAID THAT IT EVEN CAME OFF AND ALSO NOTED THAT SOME CATHETERS SEEMED TO BE MORE STICKY THAN OTHERS (LOT: JUFV2649 & LOT: JUFX2803).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13872392 ↗
• MalfunctionNov 30, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS PULLING OFF THE SKIN WHEN THE CUSTOMER WAS REMOVING THE CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Tears

  MAUDE report 12899738 ↗
• MalfunctionDec 7, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CUTS IN SKIN WHICH CAUSED PAIN AND BLEED BECAUSE OF THE SHARP PLASTIC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain; Skin Tears

  MAUDE report 10962810 ↗
• MalfunctionDec 7, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CUTS IN SKIN WHICH CAUSED PAIN AND BLEED BECAUSE OF THE SHARP PLASTIC. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain; Skin Tears

  MAUDE report 10962773 ↗
• MalfunctionDec 7, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CUTS IN SKIN WHICH CAUSED PAIN AND BLEED BECAUSE OF THE SHARP PLASTIC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain; Skin Tears

  MAUDE report 10962692 ↗
• MalfunctionMay 26, 2020Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CUSTOMER USED THE ULTRAFLEX PRODUCT, AND STATED THAT IT REMOVED SKIN. PER FOLLOW UP, THE CUSTOMER REMOVED THE CATHETER IN THE SHOWER, AND SAID THERE WAS STILL GLUE REMAINING.

  Patient problems: No Consequences Or Impact To Patient; Skin Tears

  MAUDE report 10089759 ↗
• MalfunctionJul 3, 2019Nonstandard Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG AND AS A RESULT THE PATIENT COULD NOT USE THE MALE EXTERNAL CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8757814 ↗
• MalfunctionJun 6, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO STRONG OF AN ADHESIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674790 ↗
• MalfunctionMay 28, 2019Nonstandard Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO STRONG OF AN ADHESIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8645616 ↗
• MalfunctionMar 14, 2019Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER (MEC) HAD TOO STRONG OF AN ADHESIVE. THE PATIENT ALLEGEDLY EXPERIENCED SKIN TEARING. THERE WAS NO REPORTED MEDICAL INTERVENTION.

  Patient problems: Skin Tears

  MAUDE report 8420086 ↗
• MalfunctionOct 11, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE BECAUSE THE ADHESIVE WAS TOO STRONG. THE COMPLAINANT REPORTED IT TOOK ABOUT 15 MINUTES FOR HIM TO REMOVE THE CATHETER.

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

  MAUDE report 7957311 ↗
• MalfunctionSep 11, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG, MAKING THE CATHETER DIFFICULT TO REMOVE.

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

  MAUDE report 7864367 ↗
• MalfunctionSep 11, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG, MAKING THE CATHETER DIFFICULT TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7864362 ↗
• MalfunctionAug 27, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG, MAKING THE CATHETERS DIFFICULT TO REMOVE.

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

  MAUDE report 7820782 ↗
• MalfunctionAug 22, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO UNROLL.

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

  MAUDE report 7804296 ↗
• MalfunctionJul 25, 2018Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS REMAINING ON THE PATIENTS SKIN AFTER REMOVAL.

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

  MAUDE report 7719645 ↗
• MalfunctionMay 10, 2017Difficult to Remove; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETER WAS TOO TIGHT AND DIFFICULT TO REMOVE. THE PATIENT STATES THAT HE WAS NEVER MEASURED FOR THE CATHETER AND WILL TRY A SIZE BIGGER.

  Patient problems: No Information

  MAUDE report 6556847 ↗
• InjuryApr 25, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SORES ON HIS PENIS.

  Patient problems: Injury

  MAUDE report 6518803 ↗