UltraFlex™ Self-Adhering Male External Catheter 33301Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741070730), received between Aug 24, 2017 and May 3, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2022Nonstandard Device; Patient Device Interaction Problem; Nonstandard Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER (MEC) WAS VERY STICKY. THE PATIENT HAD BEEN USING THE MEC PRODUCTS FOR MORE THAN 90 DAYS. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, THE PATIENT¿S WIFE REPORTED THE MALE EXTERNAL CATHETERS WERE TOO STICKY TO USE. THREE OF THE PRODUCTS STUCK TO THEMSELVES WHEN THEY WERE REMOVED FROM THE PACKAGE. THE FOURTH MEC ADHERED TO THE PATIENT WHEN APPLIED AND CAUSED PAIN. THE PATIENT'S WIFE ALSO REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2022 DUE TO SEPSIS. A CLINICAL FOLLOW UP CALL WAS PLACED ON (B)(6) 2022, BUT THE PATIENT¿S WIFE DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION AND REQUESTED NOT TO BE CONTACTED AGAIN. THERE WAS NO INDICATION THAT THE DEVICE CONTRIBUTED TO THE PATIENT¿S DEATH.

  Patient problems: Pain

  MAUDE report 14269812 ↗
• MalfunctionJan 14, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS VERY STICKY. PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 13257763 ↗
• MalfunctionAug 25, 2021Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE PATIENT NEEDED HELP WITH HOW TO USE EXTERNAL CATHETERS. THERE WAS NO MALFUNCTION WITH THE DEVICE. THE PATIENT WOULD CONTACT LIBERATOR OR DOCTOR FOR FURTHER INSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367180 ↗
• MalfunctionJul 30, 2020Nonstandard Device; Patient-Device Incompatibility; Nonstandard Device

  IT WAS REPORTED THAT THE EXTERNAL CONDOMS HURT TOO BAD WHEN TOOK THEM OFF. STATED THAT THE PATIENT USED WARM WATER BUT NOTHING WORKED.

  Patient problems: Pain

  MAUDE report 10345865 ↗
• MalfunctionMay 4, 2020Nonstandard Device; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE EXTERNAL'S ADHESIVE WAS TOO STRONG CAUSING THEM TO BE 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 10020921 ↗
• MalfunctionMay 1, 2020Nonstandard Device; Nonstandard Device; Adverse Event Without Identified Device or Use 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 10018221 ↗
• MalfunctionJun 27, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG THE PATIENT FELT AS THOUGH THE SKIN WAS BEING PEELED OFF OF THE PENIS AND CAUSED PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8741082 ↗
• MalfunctionJun 26, 2019Nonstandard Device; Nonstandard Device; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG CAUSING THE CUSTOMER TO EXPERIENCE SKIN TEARS AND PAIN. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abrasion; Pain; Skin Tears

  MAUDE report 8736945 ↗
• MalfunctionJun 20, 2019Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CASE OF MALE EXTERNAL CATHETERS CONTAINED 13 CATHETERS, NOT 30.

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

  MAUDE report 8718268 ↗
• MalfunctionJul 5, 2018Mechanical Problem; Difficult to Remove; Difficult to Remove

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

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7663699 ↗
• MalfunctionJun 15, 2018Nonstandard Device; Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOO STICKY, WHICH ALLEGEDLY RESULTED IN SKIN IRRITATION. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Skin Irritation

  MAUDE report 7605165 ↗
• MalfunctionOct 24, 2017Sticking

  IT WAS REPORTED THAT THE CONDOMS ADHERED TOO STRONGLY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973518 ↗
• MalfunctionAug 25, 2017Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE. THERE WAS BRUISING OF THE SKIN BUT MEDICAL ATTENTION WAS NOT NEEDED.

  Patient problems: Bruise/Contusion

  MAUDE report 6820052 ↗
• MalfunctionAug 24, 2017Fluid/Blood Leak; Split

  IT WAS REPORTED THAT THE CATHETER SPLIT DOWN THE MIDDLE DURING USE. AS A RESULT, URINE LEAKED FROM THE BELL AREA OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816711 ↗