CURE ULTRA CATHETER ULTRA10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815947020420), received between Apr 25, 2024 and Nov 11, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE "CONTINUED TO HAVE RECURRENT UTIS MANY MONTHS IN A ROW MONTH DIAGNOSED AT URGENT CARES AND HER MD SINCE WE LAST SPOKE. SHE SAID SHE HAD ONE DIAGNOSED EACH MONTH IN (B)(6)T AND FEELS LIKE SHE HAS ANOTHER ONE NOW IN NOVEMBER. THE URINE CULTURES ALWAYS GROW OUT THE SAME BACTERIA THE LAST FEW MONTHS, KLEBSIELLA PNEUMONIAE. HER SYMPTOMS ARE ALWAYS URGENCY FREQUENCY AND BURNING. FOR HER PRIOR UTIS IN (B)(6) SHE SAID SHE ALWAYS FELT BETTER FOR A FEW WEEKS AFTER ANTIBIOTIC TREATMENT BEFORE THE NEW ONE STARTED. HER SYMPTOMS RETURNED AGAIN IN (B)(6). THE END OF (B)(6) AFTER A TREATMENT COURSE OF ANTIBIOTICS FOR A POSITIVE UTI (STATED SHE WAS STARTED ON CEFINDIR BUT WHEN THAT CAME BACK AS RESISTANT AND SHE WAS SWITCHED TO ANOTHER ANTIBIOTIC - NAME CNO) SHE SAID SHE DID CHECK HER URINE CULTURE AND IT SHOWED NO GROWTH BUT SHE STILL FELT SYMPTOMATIC. SHE SAID SHE RECENTLY WENT TO URGENT CARE TO DO ANOTHER URINE TEST DUE TO HER SYMPTOMS NOT GOING AWAY AND HAS YET TO HEAR BACK ON MOST RECENT RESULTS BUT SUSPECTS ANOTHER UTI. SHE SAW HER UROLOGIST (B)(6) IN PERSON FOR FOLLOW UP BUT THEY ARE JUST MONITORING HER. SHE STILL HAS A SMALL KIDNEY STONE THEY ARE MONITORING AS WELL." SH

  Patient problems: Urinary Tract Infection

  MAUDE report 23521604 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE "CONTINUED TO HAVE RECURRENT UTIS MANY MONTHS IN A ROW MONTH DIAGNOSED AT URGENT CARES AND HER MD SINCE WE LAST SPOKE. SHE SAID SHE HAD ONE DIAGNOSED EACH MONTH IN AUG, SEPT, OCT AND FEELS LIKE SHE HAS ANOTHER ONE NOW IN NOVEMBER. THE URINE CULTURES ALWAYS GROW OUT THE SAME BACTERIA THE LAST FEW MONTHS, KLEBSIELLA PNEUMONIE. HER SYMPTOMS ARE ALWAYS URGENCY FREQUENCY AND BURNING. FOR HER PRIOR UTIS IN AUG AND SEPT SHE SAID SHE ALWAYS FELT BETTER FOR A FEW WEEKS AFTER ANTIBIOTIC TREATMENT BEFORE THE NEW ONE STARTED. HER SYMPTOMS RETURNED AGAIN IN OCTOBER. THE END OF OCTOBER (B)(6) AFTER A TREATMENT COURSE OF ANTIBIOTICS FOR A POSITIVE UTI (STATED SHE WAS STARTED ON CEFINDIR BUT WHEN THAT CAME BACK AS RESISTANT AND SHE WAS SWITCHED TO ANOTHER ANTIBIOTIC - NAME CNO) SHE SAID SHE DID CHECK HER URINE CULTURE AND IT SHOWED NO GROWTH BUT SHE STILL FELT SYMPTOMATIC. SHE SAID SHE RECENTLY WENT TO URGENT CARE TO DO ANOTHER URINE TEST DUE TO HER SYMPTOMS NOT GOING AWAY AND HAS YET TO HEAR BACK ON MOST RECENT RESULTS BUT SUSPECTS ANOTHER UTI. SHE SAW HER UROLOGIST ON (B)(6) IN PERSON FOR FOLLOW UP BUT THEY ARE JUST MONITORING HER. SHE STILL HAS A SMALL KIDNEY STONE THEY ARE

  Patient problems: Urinary Tract Infection

  MAUDE report 23521598 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "FOR ABOUT A YEAR NOW SHE HAS REMAINED UTI FREE, CONTINUING TO USE THE ULTRA10, BUT LAST MONTH ON (B)(6) DID GO IN TO SEE HER UROLOGIST WITH ONE OF THE WORST UTIS SHE HAS EVER HAD SHE SAID. SHE HAD PUS DRAINING FROM HER URETHRA AND BAD URETHRAL PAIN. SHE DID A URINE CULTURE WHICH WAS POSITIVE FOR UTI AND PRESCRIBED 2 DIFFERENT ANTIBIOTICS. SHE FELT LIKE IT NEVER GOT BETTER AND STILL NOT 100% BETTER, EVEN NOW, BUT MUCH BETTER THAN HOW SHE WAS. SHE IS ON HER LAST ANTIBIOTIC PILL TODAY AND ACTUALLY DID ANOTHER URINE TEST LAST FRIDAY (B)(6) 2025 (WHILE SHE WAS STILL ON ANTIBIOTICS) DUE TO HER CONTINUED SYMPTOMS IS STILL WAITING FOR THOSE CULTURE RESULTS AS THEY ARRIVED TO THE LAB ON MONDAY SHE WAS TOLD. SHE IS FOLLOWING UP WITH HER MD. SHE STILL HAS A SMALL KIDNEY STONE THEY ARE MONITORING. " HER TECHNIQUE WAS DISCUSSED AND SHE STATES SHE IS VERY CAUTIOUS TO FOLLOW ALL PROPER STEPS FOR CLEANLINESS. SHE ALSO SAID AFTER BOWEL MOVEMENTS SHE WILL ALSO WASH HERSELF VERY WELL EVEN IN THE SHOWER WITH SOAP AND WATER."

  Patient problems: Urinary Tract Infection

  MAUDE report 22838179 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE IS NOT BLAMING ANY DEFECT ON THIS PRODUCT BUT RATHER JUST THE ACT OF CATHING SHE WAS TOLD BY HER MD PLACES HER SUSCEPTIBLE TO UTIS." SHE REPORTS HAVING "MORE UTIS WITH USE OF THIS CATHETER THAN ANY OTHER SHE HAS PREVIOUSLY USED, ALTHOUGH SHE HAS HAD PRIOR UTIS BEFORE. SHE STATES SHE NO LONGER HAS PAIN/ PINCHING FEELING WITH THIS CATHETER - CATHS 6-7 X DAY. SHE THINKS HER INTERSTITIAL CYSTISIS WAS THE CAUSE OF THAT FEELING SHE PREVIOUSLY HAD THIS WITH PRODUCT BUT SHE HAS NEVER GOTTEN SO MANY UTIS IN A SHORT TIME FRAME, MORE SO THAN EVER PREVIOUSLY WITH ANY OTHER CATHETER AND SHE CALLED TO REPORT THIS AND EXPLORE OTHER OPTIONS. SHE SAID SHE HAS ALWAYS CLOSELY FOLLOWED UP WITH HER UROLOGIST; ALSO WITH INFECTIOUS DISEASE. SHE HAS HAD A RECENT URODYNAMICS, CYSTOSCOPY AND RENAL US. SHE HAS A SMALL KIDNEY STONE IN HER LEFT KIDNEY BUT THEY ARE JUST MONITORING IT NOW. SHE SAID HER UTI SYMPTOMS ARE USUALLY URGENCY, FREQUENCY, BLADDER PAIN BURNING AND CHILLS AND THEN SHE GOES INTO DO A URINE SAMPLE. THIS YEAR WITH USE OF THIS CATHETER SHE HAS BEEN DIAGNOSED WITH A UTI IN FEBRUARY - E. COLI. SYMPTOMS CLEARED AFTER ORAL ANTBIOTIC TREATMENT - NAME UNKNOWN. APRIL - DIAGNOSED

  Patient problems: Urinary Tract Infection

  MAUDE report 19358499 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE IS NOT BLAMING ANY DEFECT ON THIS PRODUCT BUT RATHER JUST THE ACT OF CATHING SHE WAS TOLD BY HER MD PLACES HER SUSCEPTIBLE TO UTIS." SHE REPORTS HAVING "MORE UTIS WITH USE OF THIS CATHETER THAN ANY OTHER SHE HAS PREVIOUSLY USED, ALTHOUGH SHE HAS HAD PRIOR UTIS BEFORE. SHE STATES SHE NO LONGER HAS PAIN/ PINCHING FEELING WITH THIS CATHETER - CATHS 6-7 X DAY. SHE THINKS HER INTERSTITIAL CYSTISIS WAS THE CAUSE OF THAT FEELING SHE PREVIOUSLY HAD THIS WITH PRODUCT BUT SHE HAS NEVER GOTTEN SO MANY UTIS IN A SHORT TIME FRAME, MORE SO THAN EVER PREVIOUSLY WITH ANY OTHER CATHETER AND SHE CALLED TO REPORT THIS AND EXPLORE OTHER OPTIONS. SHE SAID SHE HAS ALWAYS CLOSELY FOLLOWED UP WITH HER UROLOGIST; ALSO WITH INFECTIOUS DISEASE. SHE HAS HAD A RECENT URODYNAMICS, CYSTOSCOPY AND RENAL US. SHE HAS A SMALL KIDNEY STONE IN HER LEFT KIDNEY BUT THEY ARE JUST MONITORING IT NOW. SHE SAID HER UTI SYMPTOMS ARE USUALLY URGENCY, FREQUENCY, BLADDER PAIN BURNING AND CHILLS AND THEN SHE GOES INTO DO A URINE SAMPLE. THIS YEAR WITH USE OF THIS CATHETER SHE HAS BEEN DIAGNOSED WITH A UTI IN FEBRUARY - E. COLI. SYMPTOMS CLEARED AFTER ORAL ANTBIOTIC TREATMENT - NAME UNKNOWN. (B)(6) - DIAGNOSED

  Patient problems: Urinary Tract Infection

  MAUDE report 19358494 ↗
• MalfunctionApr 25, 2024Sharp Edges; Sharp Edges

  END USER STATES "SOME CATHETERS ARE NOT POLISHED AND THEY SCRATCH HER AND SHE GETS A UTI. NO MEDICAL ATTENTION REPORTED."

  Patient problems: Urinary Tract Infection

  MAUDE report 19179781 ↗