CURE ULTRA CATHETER ULTRA12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815947020437), received between Mar 3, 2020 and Aug 23, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETERS "THEY FEEL TOO FLEXIBLE LIKE THEY "REDUCED THE AMOUNT/ QUALITY OF THE PLASTIC" THEY ARE USING ON THEM MAKING THEM TOO BENDABLE NOW. SHE WAS ALWAYS ABLE TO PLACE THEM IN URETHRA BY FEEL JUST FINE WITHOUT A MIRROR EASILY. SHE SAID NOW THEY ARE JUST BENDING, DIFFICULT TO PLACE AND OFTEN SLIDE INTO VAGINA. USING A MIRROR HELPS BUT WITHOUT IT, SHE FINDS SHE CAN GO THROUGH QTY"10" FOR EACH TIME SHE CATHS UNTIL 1 FINALLY GOES IN AND THIS HAS NEVER BEEN THE CASE BEFORE. SHE USES SO MANY AS SHE DOESN'T WANT TO USE A CATHETER THAT HAS BEEN CONTAMINATED IN ANY WAY HAVING NOT GONE STRAIGHT INTO URETHRA. SHE SAID ALL THE CATHETERS IN HER LAST 2 ORDERS HAVE BEEN LIKE THIS AND SHE WILL RUN OUT BEFORE HER NEXT ORDER SINCE SHE HAS TO USE SO MANY TO GET ONE TO GO IN SINCE THEY BEND SO EASILY. THEY ARE STORED IN A 74 DEGREE ROOM. SHE WAS "DIAGNOSED WITH A UTI" IN (B)(6) FROM HER PRIMARY. SHE THINKS ALL THE "POKING AROUND" BECAUSE OF THIS CHANGE SHE HAS NOTED IN THE PLASTIC AND WITH THE CATHETERS BENDING POSSIBLY THIS COULD HAVE CAUSED THIS. SHE HAD NO UTI SYMPTOMS AT THE TIME. IT WAS AN ANNUAL PHYSICAL AND THEY DID A ROUTINE URINE TEST. HER MD CALLED HER WITH THE RESULT

  Patient problems: Urinary Tract Infection

  MAUDE report 17606786 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE HAD BURNING AND A UTI AFTER USE OF THE ULTRA12 CATHETER, USED A COUPLE "ABOUT A WEEKS WORTH" FROM 1 MU OF LOT 22B20803. SHE HAS BEEN CATHING FOR 2 YRS NOW 2 X A DAY AS WELL AS VOIDS ON OWN THROUGHOUT THE DAY. SHE SAID IT IS DUE TO HER BLADDER NOT EMPTYING." SHE SAID "SHE ONLY USED "ABOUT A WEEKS WORTH" OF THESE CATHING AND SHE FELT LIKE THEY WERE TOO SHORT FOR HER ANATOMY TO FULLY DRAIN HER. SHE SAID SHE PUT THEM "AS FAR AS THEY WOULD GO" FUNNEL UP TO URETHRA AND AFTER SHE DRAINED, OFTENTIMES 20 MIN LATER SHE FELT LIKE SHE HAD TO VOID AGAIN AND THEN SHE WOULD VOID ON HER OWN MORE URINE OUT. SHE ALSO SAID IT ALSO BURNED "FOR JUST A LITTLE WHILE" AFTER SHE USED THE CATHETER AND THEN SHE WOULD WASH HERSELF WITH SOAP AN WATER IN PERI/ URETHRAL AREA AND THE BURNING WOULD GO AWAY AFTER CATHING. SHE HAS NO ALLERGIES TO ANYTHING SHE IS AWARE OF TO LUBRICANT SHE JUST SAID SHE HAD SOME "ALLERGIES TO DRUGS TAKEN BY MOUTH." SHE MENTIONED 2-3 DAYS AFTER USING THESE SHE WAS DIAGNOSED WITH A UTI. SHE SAID SHE IS NOT SURE IF IT WAS DUE TO THIS CATHETER OR NOT. "I DON'T KNOW IF THIS WAS JUST A COINCIDENCE" SHE HAD URGENCY, DID NOT FEEL HERSELF. SHE DID DO URINE TESTING AND SAID

  Patient problems: Urinary Tract Infection

  MAUDE report 16867337 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRODUCT END USER IS AN ADULT FEMALE WITH URINARY RETENTION WHO STARTED PERFORMING INTERMITTENT URINARY SELF-CATHETERIZATION 3-4XDAY APPROXIMATELY A MONTH AGO DUE TO PROLAPSED UTERUS AND "BOWEL" ISSUES. END USER REPORTS "BURNING AND STINGING TO THE URETHRA DURING CATHETERIZATION AND FOR UP TO 15 MINUTES AFTERWARD THEN HAS "DISCOMFORT" TO THE FLANK AND BLADDER AREAS". IT IS UNCLEAR IF THE DISCOMFORT IS RELATED THE CATHETER OR HER HEALTH ISSUES IE PROLAPSED UTERUS. END USER FEELS SHE FOLLOWS THE RECOMMENDED PROTOCOL FOR CATHETERIZATION AND FEELS SHE EMPTIES HER BLADDER COMPLETELY. SHE STATES SHE HAS BEEN TREATED FOR 3 URINARY TRACT INFECTIONS OVER THE PAST MONTH WHICH SHE WONDERS IF THEY ARE RELATED TO THE CATHETERS. SHE DID A HOME TEST WHICH INDICATED URINARY TRACT INFECTION AND THEN WAS SEEN IN HER LOCAL URGENT CARE, A URINE CULTURE CONFIRMED URINARY TRACT INFECTION. SHE WAS GIVEN AN ANTIBIOTIC WHICH WAS INEFFECTIVE AND THEN WAS SWITCHED TO KEFLEX ANTIBIOTIC WHICH SHE COMPLETED.

  Patient problems: Dysuria; Urinary Tract Infection

  MAUDE report 13409396 ↗
• InjuryMar 3, 2020Biocompatibility; Biocompatibility

  PATIENT (USER) REPORTED SHE IS SENSITIVE TO THE LUBRICANT AND HAS BEEN WIPING IT OFF THE CATHETERS BEFORE USING THEM. COINCIDING WITH CATHETER USE THE PATIENT ACQUIRED A URINARY TRACT INFECTION. SHE HAS BEEN PRESCRIBED AN ANTIBIOTIC AND FEELS BETTER NOW BUT SHE IS STILL TAKING IT (A 10 DAY COURSE). PATIENT IS CHANGING TO A CATHETER THAT IS NOT PRE-LUBRICATED AND PLANS TO APPLY HER OWN LUBRICANT.

  Patient problems: Skin Irritation; Urinary Tract Infection

  MAUDE report 9781582 ↗