UltraFlex™ Self-Adhering Male External Catheter 33101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741070662), received between Mar 17, 2020 and May 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE NEW BATCH OF MALE EXTERNAL CATHETERS WERE DIFFICULT TO REMOVE. PATIENT WAS NORMALLY ABLE TO REMOVE USING A WARM COMPRESS BUT WITH THIS BATCH THEY HAD TO USE ALCOHOL AND A COTTON SWAB TO GET THE CATHETER OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376394 ↗
• MalfunctionMar 17, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETERS WHICH RESULTED IN IT MAKING THEM DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9841551 ↗