CURE CATHETER HM14UKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815947020505), received between Nov 18, 2019 and Mar 29, 2023 — classified as 1 injury, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Unsealed Device Packaging; Difficult to Remove; Unsealed Device Packaging; Difficult to Remove

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639953 ↗
• MalfunctionMar 29, 2023Unsealed Device Packaging; Difficult to Remove; Unsealed Device Packaging; Difficult to Remove

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639374 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) REPORTED HE EXPERIENCED A URINARY TRACT INFECTION (UTI) AND THE CATHETER FELT DIFFERENT AFTER USING THE CATHETER PACKAGED WITH THE CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD).

  Patient problems: Urinary Tract Infection

  MAUDE report 9339271 ↗