CURE ULTRA MALE CATHETER ULTRA M18CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815947021137), received between Jun 3, 2022 and Jan 7, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Product Quality Problem

  PATIENT STATED WITH EVERY ORDER THERE IS AT LEAST TWO TO THREE CATHETERS THAT ARE DRY. PATIENT HAS USED BEFORE. NO LOT NUMBER GIVEN. THIS EMDR COVERS THE UNKNOWN ACTUAL NUMBER OF DRY CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989962 ↗
• MalfunctionJan 7, 2026Product Quality Problem

  PATIENT STATED WITH EVERY ORDER THERE IS AT LEAST TWO TO THREE CATHETERS THAT ARE DRY. PATIENT HAS USED BEFORE. NO LOT NUMBER GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989961 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS MULTIPLE UTIS OVER THE LAST YEAR, ABOUT EVERY 6 MONTHS HE SAID, LAST ONE IN (B)(6) 2022 WHILE USING THESE CATHETERS. WHEN ASKED IF HE THINKS THE CATHETERS ARE THE CAUSE OF HIS PREVIOUS UTIS HE SAID HE ISN'T SURE. HE SAID HIS DOCTOR PUT HIM ON A DAILY LOW DOSE PROPHYLACTIC ANTIBIOTIC AFTER HIS LAST UTI IN FEB/MARCH AND HE DOES NOT KNOW THE NAME OF IT, BUT IT HAS BEEN WORKING TO PREVENT FURTHER UTIS SINCE HIS LAST UTI IN FEB/MARCH AND STILL USES THESE CATHETERS. HE SAID HE IS ALWAYS MINDFUL TO WASH HIS HANDS PRIOR TO CATH USE, IF THEY TOUCH ANYTHING AND BECOME UNSTERILE HE THROWS THEM AWAY AND HE DOES WIPE PRIOR TO INSERTION WITH AN ANTIBACTERIAL WIPE. HIS SYMPTOMS THAT INDICATED HE WAS HAVING A UTI WERE ALWAYS FOUL ODOR, IRRITATION, FEVERS, AND TROUBLE URINATING (SMALL FREQUENT AMTS), BURNING. HE SAID HE ALWAYS WENT TO DO A URINE SAMPLE AND HIS DOCTOR FOUND EAT TIME THAT HE WAS POSITIVE FOR UTI AND THEY PRESCRIBED HIM AN ANTIBIOTIC COURSES EACH TIME BEFORE BEING PLACED ON CURRENT LOW DOSE DAILY ANTIBIOTIC. HE HAS BEEN USING THESE CATHETERS FOR A LITTLE LESS THAN THE FULL YEAR HE HAS BEEN CATHING. HE SAID HE HAD TRIALED OTHER CATHETERS BEFORE CHOOSING THE ULTRAM18C.

  Patient problems: Urinary Tract Infection

  MAUDE report 14596479 ↗