CURE CATHETER F14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815947020215), received between Jan 30, 2019 and Jul 4, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22403280 ↗
• MalfunctionJul 5, 2023Sharp Edges; Sharp Edges

  END USER REPORTS ONE F14 CATHETER WITH A DEFORMED SHARP EDGED TIP. END USER STATES SHE HAS BEEN USING THESE "FOR YEARS, 6X A DAY, TO EMPTY HER BLADDER DUE TO HER BLADDER'S INABILITY TO EMPTY. SHE SAID THIS CATHETER HAS ALWAYS BEEN GREAT FOR HER. SHE SAID THIS MUST BE "ONE IN A MILLION" DEFECTS AS ALL THE YEARS SHE HAS USED THIS SHE HAS NEVER HAD THIS OCCUR. SHE SAID SHE ONLY FOUND 1 FROM A BOX SHE USED UP THAT HAD THIS DEFECT WHERE THE TIP WAS NOT ROUNDED AS USUAL BUT RATHER LOOKED CUT OFF." SHE SAID "IT LOOKS LIKE SOMEONE CUT OFF THE END WITH A KNIFE." SHE SAID SHE USUALLY NEVER LOOKS AT THEM PRIOR TO USE AND WHEN SHE TRIED TO INSERT IT, IT DID "HURT A LITTLE" AS THE ENDS FELT SHARP SO SHE DID NOT PROCEED TO INSERT. SHE REMOVED IT AND LOOKED AT IT AND NOTED THIS DEFECT AND DID NOT CONTINUE TO USE. SHE SAID SHE HAS "NO DAMAGE" TO HERSELF FROM HAVING ATTEMPTED USE OF THIS. SHE SAID SHE TYPICALLY WILL TRY AND VOID FIRST TO WET HER URETHRA THEN DOES PLACE LUBRICANT ON HER CATHETER PRIOR TO INSERTION. SHE NORMALLY DOESN'T INSPECT THEM PRIOR TO USE AS SHE IS SO USED TO CATHING." END USER WAS ADVISED TO LOOK AT HER CATHETERS PRIOR TO USE JUST TO MAKES NO DEFECTS ARE FOUND AND IF SO TO NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17255695 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "BLEEDING WITH THE F14 CATHETER FOR THE LAST 3 MONTHS. SHE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST 3 MONTHS." SHE STATES "SHE HAS USED THESE CATHETERS FOR MANY YEARS AND NEVER HAD BLEEDING WITH THEM BEFORE THIS IS A NEW OCCURRENCE IN THE LAST 3 MONTHS. SHE CATHS FOR RETENTION FROM BLADDER SPASMS WHICH SHE STATES CAUSE HER NOT TO EMPTY HER BLADDER AND SHE CATHS 6-7 X A DAY. PHONE CONNECTION WAS POOR SO THE INFORMATION BELOW WAS ALL I COULD OBTAIN. SHE SAID THE BLEEDING OCCURS WHEN SHE FINDS IT HARD TO PASS THE CATHETER THROUGH THE SPHINCTER BEFORE ENTERING THE BLADDER AND SHE WILL NOTE DISCOMFORT WHEN SHE REMOVES THE CATHETER. WHEN SHE LOOKS AT THE RETRACTED CATHETER SHE SEES ONLY "A LITTLE BIT (OF BLOOD) IN THE TUBE" AND STATES "IT IS NOT MUCH". IT STOPS IMMEDIATELY BUT SHE WILL NOTICE THIS OCCURS "ABOUT EVERY 3RD TIME" SHE CATHS AND IT IS NOT ALL THE TIME. SHE DOES NOT THINK IT IS A PRODUCT DEFECT WITH THE CATHETER BUT RATHER AN ANATOMICAL CHANGE OF SOME SORT. SHE SAID SHE HAS NEVER NEEDED TO LUBRICATE THE CATHETER PRIOR TO INSERTION AS SHE HAS NEVER HAD ANY ISSUES WITH THIS CA

  Patient problems: Bruise/Contusion; Urinary Tract Infection

  MAUDE report 15477774 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTED MULTIPLE UTI'S WHILE USING THE CURE F14 CATHETER THROUGHOUT HER LIFE, UNKNOWN LOTS, UNKNOWN MU/S, UNKNOWN QTY. CONSUMER HAS BEEN USING THIS PRODUCT CURE F14 NEARLY ALL HER LIFE SHE SAID AS SHE WAS BORN WITH SPINA BIFIDA AND THE NEED FOR CATHETERIZATION VIA HER URETHRA. CALL WAS KEPT BRIEF AS SHE HAD TO GET TO AN APPOINTMENT. SHE SAID TWICE SHE DOESN'T THINK HER UTIS ARE CAUSED BY THE CATHETERS BUT RATHER THE CONDITIONS SHE HAS. CONSUMER SAID HER CHRONIC UTIS HAVE CAUSED HER MULTIPLE HOSPITAL STAYS, TREATED WITH ANTIBIOTICS MOST RECENTLY AS A WEEK AGO. SHE SAID HER UTIS HAVE BEEN MORE FREQUENT LATELY BUT HAVE OCCURRED ALL THROUGHOUT HER LIFE. SHE SAID HER UTIS ARE ALWAYS CHECKED BY HER MD WITH URINE TESTING AND THIS IS HOW SHE IS DIAGNOSED WITH UTIS. SHE WAS BORN WITH SPINA BIFIDA AND HAS BEEN CATHING ALL HER LIFE, MOSTLY 7 X A DAY SOMETIMES MORE OR LESS DEPENDING ON HOW MUCH WATER SHE DRINKS. WE EXPLORED HER CATHETERIZATION TECHNIQUE AND SHE OFTEN STILL USES THE CATHETER IF IT BECOMES UNSTERILE PRIOR TO INSERTION. OFTEN IT WILL TOUCH THE COUNTER AND THEN SHE WILL WIPE THE CATHETER ITSELF DOWN WITH A BABY WIPE PRIOR TO INSERTION. SHE SAID SHE HAS NEVER USED LUBRICA

  Patient problems: Urinary Tract Infection

  MAUDE report 15275134 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE "PERFORMS INTERMITTENT URINARY SELF-CATHETERIZATION EVERY 4-6 HRS DUE TO RETENTION FOR THE PAST 30 YEARS." END USER REPORTS THE "CURE F14 IS 5 ¼¿ LONG (END OF HUB TO TIP OF CATHETER) INSTEAD OF 6¿ AS NOTED ON THE PACKAGE AND SHE FEELS SHE DOES NOT EMPTY COMPLETELY BECAUSE OF THIS AND ATTRIBUTES THE 3 URINARY TRACT INFECTIONS UTI¿S SHE HAS HAD SINCE (B)(6) 2022 TO THIS ISSUE. UTI SYMPTOMS REPORTED TO HER HCP INCLUDED BURNING WITH VOIDING, BACK PAIN, LOW GRADE FEVER. A URINE CULTURE AND BLOOD WORK WERE DONE. SHE WAS GIVEN 3 COURSES OF ORAL ANTIBIOTIC - MACROBID X 1 AND CURRENTLY COMPLETING A COURSE OF CEPHELEX.."

  Patient problems: Discomfort; Fever; Urinary Tract Infection

  MAUDE report 13636989 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) REPORTED SHE WAS ADVISED TO CHANGE TO PRELUBRICATED CATHETERS AND DISCONTINUE USING CATHETERS SHE HAS ON HAND. SHE REPORTED SHE WAS ADDING LUBRICANT TO THE CATHETERS AND HER DOCTOR BELIEVES SHE WAS GETTING URINARY TRACT INFECTIONS (UTI) BECAUSE OF THE PROCESS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9089422 ↗
• InjuryJan 30, 2019Sharp Edges; Sharp Edges

  PATIENT (USER) REPORTED THAT RECENTLY SHE WAS FEELING SOME SCRATCHINESS AND A SLIGHT BURNING SENSATION WHILE USING URINARY CATHETERS. DURING FOLLOW-UP THE PATIENT REPORTED SHE ACQUIRED A UTI IN NOVEMBER. HER DOCTOR DELAYED PRESCRIBING AN ANTIBIOTIC AND THE UTI SPREAD TO A BLADDER INFECTION. THE PATIENT TOOK ANTIBIOTIC COURSES IN DECEMBER AND JANUARY TO TREAT THE INFECTION. AFTER FINISHING THE ANTIBIOTICS THE PATIENT REPORTED A COMPLETE RECOVERY FROM THE INFECTION.

  Patient problems: Burning Sensation; Skin Irritation; Urinary Tract Infection

  MAUDE report 8291088 ↗

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 (