CURE CATHETER M14UKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947020499), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K072539); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS HE HAS EXPERIENCED UTIS DURING PAST USING THIS PRODUCT, NOT BLAMING THIS PRODUCT FOR HIS UTIS. THIS HAS BEEN HIS PREFERRED CATHETER, LONG TIME USER. HE SAID SINCE HE STARTED CATHING 13 YRS AGO, HE WAS NOT PRONE TO UTIS. HE SAID IT TOOK HIM ABOUT 5 YRS INTO CATHING TO GET HIS FIRST UTI AND THEN GOT ANOTHER ONE 3 YRS AFTER THAT. EARLIER THIS YEAR HE SAID HE STARTED GETTING MULTIPLE UTIS HE SAID, "ABOUT 4 OR 5" OF THEM DURING THE TIME FROM JAN TO MAY OF THIS YEAR. HE SAID HIS SYMPTOMS WERE BURNING AND MILKY WHITE SUBSTANCE COMING OUT WITH URINE WHEN HE WOULD CATH., HE SAID EACH TIME HE WOULD GO DO A URINE CULTURE AND NEEDED PRESCRIPTION ANTIBIOTICS WHICH WOULD RESOLVE HIS SYMPTOMS. HE SAID HE HAS BEEN MORE MINDFUL IN HIS HYGIENE AND IN DOING SO, HAS REMAINED UTI FREE SINCE MAY OF THIS YEAR. HE BELIEVES HIS TECHNIQUE TO KEEP BETTER ATTENTION TO HIS HYGIENE HAS BEEN IMPROVED AND THIS HAS HELPED HIM THE MOST TO AVOID UTIS. HE SAID NOW HE IS MINDFUL TO WASH HIS HANDS, WEARS GLOVES AND USES ADULT WIPES FROM MCKESSON TO CLEANSE HIS PENIS/ MEATUS PRIOR TO CIC AND THEN ALSO CLEANSES WITH A BZK WIPE AFTERWARDS. HE SAID THIS CONSISTENCY WITH HIS HYGIENE HAS MADE ALL THE DIFFERE

  Patient problems: Urinary Tract Infection

  MAUDE report 23831654 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072539. One submission often covers many models, so check the product and lot details in each record.

• Z-0004-2013 · Sep 19, 2012 · Terminated
  Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (