CURE ULTRA MALE CATHETER ULTRA M18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815947021083), received between Apr 20, 2023 and Aug 6, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Sharp Edges; Sharp Edges

  END USER IS AN 82 YR OLD MALE THAT HAS BEEN USING THIS PRODUCT FOR THE PAST 5 YRS. HE CATHS EVERY 4-6 HRS AND USES ABOUT 210/ CATHETER PER MONTH. HE HAD AN ACCIDENT IN 1963 WHICH RUPTURED HIS BLADDER, CRUSHED HIS LEFT KIDNEY AND SEVERELY AFFECTED HIS BACK. HE HAS HAD 3 BACK SURGERIES AND AFTER A BACK SURGERY 6 YRS AGO THAT LEFT HIM MOSTLY IN A WHEELCHAIR AND 5 YRS AGO HE HAS HAD TO START CIC FOR RETENTION. SINCE HIS ACCIDENT, THIS LEFT HIM WITH A URETHRAL STRICTURE. HE GETS IT DILATED ONCE A YEAR FOR YEARS NOW. HIS LAST URETHRAL DILATION BY HIS UROLOGIST WAS END OF (B)(6) 2025 WHERE HE ALWAYS GETS LEFT IN A FOLEY CATHETER FOR 4 DAYS AND THEN IT IS REMOVED AND HE RESUMES CIC (ALWAYS NOTES SOME BLEEDING WITH THIS WHICH IS NORMAL FOR HIM). HE SAID IN THE LAST FEW WEEKS STARTING ON (B)(6) 2025 HE STARTED NOTICING WITH HIS CATHETERS, NEARLY EVERY SINGLE ONE FELT LIKE THE EYELETS WERE NOT POLISHED WELL. HE SAID IT WOULD FEEL LIKE THE EYELETS WERE "SCRAPING" THE LENGTH OF HIS URETHRA WITH USE. HE SAID RIGHT BEFORE HE GOT INTO HIS BLADDER IT WAS THE WORST. HE SAID THIS WOULD CAUSE HIM OFF AND ON BLEEDING AFTER CATHING, LIGHT BLEEDING OR SPOTTING HE SAID. HE DID NOT FEEL THE CATHETERS WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22734744 ↗
• InjuryApr 20, 2023Device Handling Problem; Device Handling Problem

  CONSUMER STATED 'HAD A LOT OF BLEEDING THAT CAUSED A 2 DAY HOSPITALIZATION AND FOLEY CATHETER'. HE HAS BEEN CATHING FOR ABOUT 25 YEARS ABOUT 4 X A DAY AND HE IS PARALYZED HAS NO FEELING IN HIS BLADDER. CONSUMER STATED THE BLEEDING WAS DUE TO A RECENT DIFFERENT TIP DESCRIBING A COUDE TIP THAT CAUSED HIM THIS BLEEDING. HE WAS NOT SURE WHY HE WAS SWITCHED TO COUDE AND HE HAD NO IDEA ABOUT HOW TO INSERT THE TIP PROPERLY STATING "I WOULD INSERT IT ANY OLD WAY" PRIOR TO BLEEDING EPISODE AS HE WAS NEVER INSTRUCTED ON HOW TO CATHETERIZE PROPERLY WITH COUDE TIP. HE THINKS THE TIP IS WHAT CAUSED HIM THE BLEEDING EPISODE. A LITTLE OVER A MONTH AGO HE SAID HE WAS AT A ROUTINE MD CHECK UP APPT AFTER HE HAD RECENTLY CATHED THAT DAY AND HE TOLD HIS MD HE HAD BEEN HAVING A LARGE AMOUNT OF BLEEDING AFTER HE HAD CATHETERIZED, HE SAID HIS ENTIRE DIAPER WAS "FULL OF BLOOD" AFTER THAT CATH. THAT MD ADMITTED HIM TO HOSPITAL WHERE THEY PLACED A FOLEY IN HIM AND IRRIGATED HIM WELL UNTIL BLEEDING STOPPED. HE STAYED IN HOSPITAL FOR 2 DAYS AND THEN SENT HOME WITH FOLEY FOR A MONTH. ABOUT A WEEK AND HALF AGO HE WENT INTO HIS UROLOGIST TO FOLLOW UP AND A CYSCTOSCOPY WAS DONE AND "HE COULDN'T FIND ANYTHING WRON

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16776140 ↗