UltraFlex™ Self-Adhering Male External Catheter 33104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741070693), received between Sep 4, 2017 and Aug 11, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2022Inaccurate Flow Rate; Device Handling Problem; Inaccurate Flow Rate; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTIES WITH MALE EXTERNAL CATHETER. STATED THAT WHEN THE PATIENT URINATES, THE URINE STAYED INSIDE THE TIP OF THE CATHETER AND WOULD NOT FLOW DOWN THE TUBING AND INTO THE BAND AND CAUSED LEAKAGE AND SAID IT SEEMED LIKE THERE WAS A POCKET OF AIR AND THE URINE WOULD NOT FLOW. INQUIRER CONFIRMED THAT THE PATIENT HAD BEEN CONNECTING THE BAG AND TUBING TO THE MALE EXTERNAL CATHETER PRIOR TO PLACING THE CATHETER ON THE PENIS AND IT DID NOT FEEL LIKE THE PATIENT GOT A GOOD GRIP FROM THE ADHESIVE ON THE CATHETER AND ALSO DISCUSSED WAYS TO PREVENT AIR LOCK, PUT THE CATHETER ON FIRST THEN CONNECTED THE TUBING OR BAG TO THE TIP AND EXERCISING THE BAG PRIOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208874 ↗
• MalfunctionAug 6, 2018Nonstandard Device; Material Too Rigid or Stiff; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE CATHETER WAS TOO STRONG. THE PATIENT ALLEGEDLY EXPERIENCED SKIN TEARING AND BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient; Skin Tears

  MAUDE report 7752624 ↗
• MalfunctionFeb 5, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ADHESIVE OF THE CATHETER WAS TOO STRONG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7241614 ↗
• MalfunctionSep 4, 2017Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER ADHESIVE WAS TOO STRONG MAKING IT DIFFICULT TO REMOVE FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6840851 ↗