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UltraFlex™ Self-Adhering Male External Catheter 33305Recalls & reported problems

C. R. Bard, Inc. · UltraFlex™ Self-Adhering Male External Catheter · Class 1

All models of UltraFlex Self-Adhering Male External Catheter (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741070815), received between Jun 6, 2019 and Apr 21, 2022 — classified as 2 injuries, 3 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

Device problems

  • Nonstandard Device2
  • Adverse Event Without Identified Device or Use Problem1
  • Biocompatibility1
  • Defective Device1
  • Inadequacy of Device Shape and/or Size1
  • Product Quality Problem1
  • Structural Problem1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Blood Loss1
  • Patient Problem/Medical Problem1
  • Urinary Tract Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 21, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS NOT ADHERING AND FALLING OFF. STATED THAT THEY HAD TROUBLE FITTING THE CATHETER, HAD BLEEDING FROM BLADDER AND HAD A BLADDER CANCER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

    MAUDE report 14166721 ↗
  • MalfunctionJul 3, 2020Nonstandard Device; Nonstandard Device; Structural Problem

    IT WAS REPORTED THAT THE CATHETER HAD ADHESIVE BOTH INSIDE AND OUTSIDE.

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

    MAUDE report 10228167 ↗
  • MalfunctionJun 3, 2020Nonstandard Device; Nonstandard Device; Defective Device

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE DEFECTIVE AND HAD ADHESION ALL OVER THEM. TWO PRODUCTS WERE ALLEGED 33304 AND 33305.

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

    MAUDE report 10113561 ↗
  • InjuryJun 1, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING DUE TO URINARY TRACT INFECTION WHILE USING A MALE EXTERNAL CATHETER.

    Patient problems: Blood Loss; Patient Problem/Medical Problem; Urinary Tract Infection

    MAUDE report 10106281 ↗
  • MalfunctionJun 6, 2019Product Quality Problem; Product Quality Problem

    IT WAS REPORTED THAT THE MECS HAD TOO MUCH ADHESIVE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8674786 ↗

Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices

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Sources and updates

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