UltraFlex™ Self-Adhering Male External Catheter 33102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741070679), received between Nov 7, 2017 and Sep 8, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2020Difficult to Remove; Unintended Movement; Difficult to Remove

  IT WAS REPORTED THAT USER HAD TO USE SENSE CARE STING FREE ADHESIVE REMOVER TO GET THE CATHETERS OFF COMFORTABLY SEVERAL MONTHS AGO. THE CATHETER KEPT COMING OFF ON THEIR OWN WITHOUT THE ADHESIVE REMOVER OVER PAST FEW WEEKS AND ALSO STATED THAT THERE WAS A NUMBER OF CATHETERS WITH EXPIRATION DATES OF 2024 AND FEW WITH 2005 EXPIRATION DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10501095 ↗
• MalfunctionJan 22, 2019Nonstandard Device; Material Integrity Problem; Nonstandard Device

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

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

  MAUDE report 8268738 ↗
• MalfunctionAug 8, 2018Labelling, Instructions for Use or Training Problem; Component Missing; Component Missing

  IT WAS REPORTED THAT THE CATHETER DID NOT COME WITH THE INSTRUCTIONS FOR USE.

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

  MAUDE report 7763096 ↗
• MalfunctionJul 18, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS STRONG.

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

  MAUDE report 7697971 ↗
• MalfunctionNov 7, 2017Difficult to Remove

  IT WAS REPORTED THAT A LARGE AMOUNT OF ADHESIVE WAS LEFT ON THE PATIENT'S SKIN FOLLOWING REMOVAL OF THE CATHETER. THE PATIENT REPORTEDLY EXPERIENCED DIFFICULTY REMOVING THE ADHESIVE AND HAD USED A PETROLEUM PRODUCT AND WARM COMPRESSES TO SUCCESSFULLY REMOVE THE ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7007746 ↗