CURE CATHETER F14NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00815947020246), received between Aug 22, 2022 and Nov 29, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2023Off-Label Use; Off-Label Use

  CONSUMER REPORTS "SHE SOMETIMES GETS UTIS WITH USE OF CATHETERS, OF AN UNKNOWN QTY, UNKNOWN MUS AND UNKNOWN LOTS. CONSUMER REPORTS THAT SHE WASHES AND REUSES HER USUAL F14NC CATHETERS AND THIS CAUSED HER A UTI. SHE HAS ALWAYS USED THE CATHETER F14NC AND IT HAS WORKED WELL FOR HER ABLE TO GET THEM IN TO DRAIN EASILY. SHE HAS NEVER NEEDED TO USE LUBE SHE SAID. SHE SAID SOON AFTER SHE STARTED USING THE F14NC CATHETERS SHE WOULD WASH AND RE-USE SHE WOULD "SANITIZE BY SOAKING THEM IN ALCOHOL" SHE FELT LIKE HER URGENCY, BURNING AND JUST BLADDER PAIN KEPT GETTING WORSE AND SHE KNEW SHE HAD A UTI. HER PCP PLACED AN ORDER FOR HER TO GO THE LAB FOR A URINE SAMPLE AND SHE WAS THEN PRESCRIBED ON A COURSE OF 5 DAYS OF ANTIBIOTICS (NAME UNKNOWN) WHICH SHE IS STILL FINISHING UP AND FEELING "A LITTLE BIT BETTER." SHE ADMITS SHE HAS HAD MANY UTIS AND THE LAST ONE SHE REMEMBERS BEING ABOUT 2 MONTHS AGO WITH THE SAME SYMPTOMS AND SHE NEEDED TO UNDERGO LAB TESTING (UA AND URINE CULTURE AND NEEDED ANTIBIOTICS THEN TOO.) SHE SAID SHE THINKS SHE GETS THESE UTIS BECAUSE SHE ADMITS TO OFTEN WASHING AND REUSING HER CATHETERS BECAUSE SHE NEEDS MORE THAN WHAT THEY WILL GIVE HER IN SUPPLIES. SHE SAID SHE FEELS

  Patient problems: Urinary Tract Infection

  MAUDE report 18229455 ↗
• InjuryNov 29, 2023Off-Label Use; Off-Label Use

  CONSUMER REPORTS "SHE SOMETIMES GETS UTIS WITH USE OF CATHETERS, OF AN UNKNOWN QTY, UNKNOWN MUS AND UNKNOWN LOTS. CONSUMER REPORTS THAT SHE WASHES AND REUSES HER USUAL F14NC CATHETERS AND THIS CAUSED HER A UTI. SHE HAS ALWAYS USED THE CATHETER F14NC AND IT HAS WORKED WELL FOR HER ABLE TO GET THEM IN TO DRAIN EASILY. SHE HAS NEVER NEEDED TO USE LUBE SHE SAID. SHE SAID SOON AFTER SHE STARTED USING THE F14NC CATHETERS SHE WOULD WASH AND RE-USE SHE WOULD "SANITIZE BY SOAKING THEM IN ALCOHOL" SHE FELT LIKE HER URGENCY, BURNING AND JUST BLADDER PAIN KEPT GETTING WORSE AND SHE KNEW SHE HAD A UTI. HER PCP PLACED AN ORDER FOR HER TO GO THE LAB FOR A URINE SAMPLE AND SHE WAS THEN PRESCRIBED ON A COURSE OF 5 DAYS OF ANTIBIOTICS (NAME UNKNOWN) WHICH SHE IS STILL FINISHING UP AND FEELING "A LITTLE BIT BETTER." SHE ADMITS SHE HAS HAD MANY UTIS AND THE LAST ONE SHE REMEMBERS BEING ABOUT 2 MONTHS AGO WITH THE SAME SYMPTOMS AND SHE NEEDED TO UNDERGO LAB TESTING (UA AND URINE CULTURE AND NEEDED ANTIBIOTICS THEN TOO.) SHE SAID SHE THINKS SHE GETS THESE UTIS BECAUSE SHE ADMITS TO OFTEN WASHING AND REUSING HER CATHETERS BECAUSE SHE NEEDS MORE THAN WHAT THEY WILL GIVE HER IN SUPPLIES. SHE SAID SHE FEELS

  Patient problems: Urinary Tract Infection

  MAUDE report 18229454 ↗
• MalfunctionMar 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "CATHETERS INSIDE MANUFACTURER BOX ARRIVED COVERED IN BLACK POWDER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553425 ↗
• MalfunctionMar 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "CATHETERS INSIDE MANUFACTURER BOX ARRIVED COVERED IN BLACK POWDER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553421 ↗
• MalfunctionMar 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "CATHETERS INSIDE MANUFACTURER BOX ARRIVED IN A STRANGE/OFF COLOR AND COVERED IN BLACK POWDER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553420 ↗
• InjuryNov 18, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS RECURRENT UTIS FOR LAST 3 MONTHS WITH USE OF F14NC CATHETERS. SHE SAID "SHE REALLY ISN'T SURE WHY SHE HAS BEEN GETTING SO MANY UTIS ALL OF A SUDDEN THESE LAST 3 MONTHS. SHE HAS BEEN USING THESE CATHETERS FOR MANY YEARS DURING HER 15 YEARS CATHING AND DIDN'T GET UTIS PRIOR WITH USE OF THESE. SHE CATHS 6 X A DAY FOLLOWING NERVE DAMAGE TO HER BLADDER FOLLOWING A TUMOR THAT WAS REMOVED FROM HER SPINE. SHE SAID SHE DID HAVE KIDNEY STONES DURING THESE LAST 3 MONTHS SHE GOT SURGICALLY TAKEN CARE OF AND SHE THOUGHT THAT WAS TO BLAME FOR HER UTIS AS SHE KNOWS STONES WILL PLACE HER AT RISK FOR UTIS. SHE SAID SHE HAS TO FOLLOW UP WITH HER UROLOGIST TO FOLLOW UP POST SURGICALLY AS SHE WAS RECENTLY X-RAYED TO ENSURE ALL STONES GONE. SHE SAID SHE HASN'T HAD TYPICAL UTI SYMPTOMS AND DENIES ALL OTHER UTI SYMPTOMS WITH HER ONLY SYMPTOM IS HAVING A "DRAGGY FEELING" AND JUST DOESN'T "FEEL WELL" SO SHE CALLS HER UROLOGIST AND THEY HAVE HER DO A URINE SAMPLE AND THEY HAVE HER TREATED WITH ANTIBIOTICS BASED ON URINE RESULTS SHOWING UTIS. SHE MENTIONED SHE HAS HAD AMOXICILLIN, BACTRIM ROUNDS DURING LAST 3 MONTHS SHE HAS HAD AND SHE IS CURRENTLY TAKING A TREATMENT ROUND OF BACTRIM SINCE L

  Patient problems: Urinary Tract Infection

  MAUDE report 15827623 ↗
• InjuryNov 18, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS RECURRENT UTIS FOR LAST 3 MONTHS WITH USE OF F14NC CATHETERS. SHE SAID "SHE REALLY ISN'T SURE WHY SHE HAS BEEN GETTING SO MANY UTIS ALL OF A SUDDEN THESE LAST 3 MONTHS. SHE HAS BEEN USING THESE CATHETERS FOR MANY YEARS DURING HER 15 YEARS CATHING AND DIDN'T GET UTIS PRIOR WITH USE OF THESE. SHE CATHS 6 X A DAY FOLLOWING NERVE DAMAGE TO HER BLADDER FOLLOWING A TUMOR THAT WAS REMOVED FROM HER SPINE. SHE SAID SHE DID HAVE KIDNEY STONES DURING THESE LAST 3 MONTHS SHE GOT SURGICALLY TAKEN CARE OF AND SHE THOUGHT THAT WAS TO BLAME FOR HER UTIS AS SHE KNOWS STONES WILL PLACE HER AT RISK FOR UTIS. SHE SAID SHE HAS TO FOLLOW UP WITH HER UROLOGIST TO FOLLOW UP POST SURGICALLY AS SHE WAS RECENTLY X-RAYED TO ENSURE ALL STONES GONE. SHE SAID SHE HASN'T HAD TYPICAL UTI SYMPTOMS AND DENIES ALL OTHER UTI SYMPTOMS WITH HER ONLY SYMPTOM IS HAVING A "DRAGGY FEELING" AND JUST DOESN'T "FEEL WELL" SO SHE CALLS HER UROLOGIST AND THEY HAVE HER DO A URINE SAMPLE AND THEY HAVE HER TREATED WITH ANTIBIOTICS BASED ON URINE RESULTS SHOWING UTIS. SHE MENTIONED SHE HAS HAD AMOXICILLIN, BACTRIM ROUNDS DURING LAST 3 MONTHS SHE HAS HAD AND SHE IS CURRENTLY TAKING A TREATMENT ROUND OF BACTRIM SINCE L

  Patient problems: Urinary Tract Infection

  MAUDE report 15826844 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "THIS PAST YEAR SHE HAS HAD MORE UTIS THAN IN THE PAST, ONCE EVERY COUPLE MONTHS WHILE USING THIS CATHETER. SHE SAID HER SYMPTOMS ARE TYPICALLY SHARP PAIN IN HER LOWER FRONT ABDOMEN AND BACK PAIN. SOMETIMES SHE WILL HAVE NO SYMPTOMS BUT AT HER UROLOGIST APPOINTMENTS THEY WILL CHECK HER URINE AND BASED ON UA AND URINE CULTURE WILL PRESCRIBE AN ANTIBIOTIC. SHE WAS BORN WITH SPINA BIFIDA AND HAS BEEN CATHING 4 - 6 X A DAY FOR THE LAST 10 YRS. HER LAST UTI WAS DIAGNOSED THE "DAY BEFORE YESTERDAY" AND SHE SAID SHE IS TAKING AN ANTIBIOTIC TO CLEAR IT. SHE WENT INTO SEE THE MD FOR BLADDER IRRIGATION TREATMENT SHE DESCRIBED AS INSTALLATION OF AN ANTIBIOTIC INTRAVESICALLY BUT THEY COULD NOT DO IT AT THE TIME DUE TO THIS UTI AND THEY DID NOT WANT THE MEDICATION TO GO SYSTEMICALLY. SHE HAS HAD TO TAKE MULTIPLE COURSES OF ANTIBIOTICS EVERY TIME SHE GETS AN INFECTION, WHICH AGAIN HAS BEEN MORE FREQUENT OVER THE LAST YEAR WHILE USING THIS CATHETER. SHE SAID ALSO THAT HER MD STATES SHE HAS "POCKETS IN HER BLADDER" AND THE CONDITION OF THE LINING OF HER BLADDER PLACES HER AT RISK FOR UTI. SHE OFTEN MOVES HERSELF AND THE CATHETER AS SHE CATHS TO MAKE SURE SHE GETS ALL THE URINE OUT

  Patient problems: Urinary Tract Infection

  MAUDE report 15264792 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "THIS PAST YEAR SHE HAS HAD MORE UTIS THAN IN THE PAST, ONCE EVERY COUPLE MONTHS WHILE USING THIS CATHETER. SHE SAID HER SYMPTOMS ARE TYPICALLY SHARP PAIN IN HER LOWER FRONT ABDOMEN AND BACK PAIN. SOMETIMES SHE WILL HAVE NO SYMPTOMS BUT AT HER UROLOGIST APPOINTMENTS THEY WILL CHECK HER URINE AND BASED ON UA AND URINE CULTURE WILL PRESCRIBE AN ANTIBIOTIC. SHE WAS BORN WITH SPINA BIFIDA AND HAS BEEN CATHING 4 - 6 X A DAY FOR THE LAST 10 YRS. HER LAST UTI WAS DIAGNOSED THE "DAY BEFORE YESTERDAY" AND SHE SAID SHE IS TAKING AN ANTIBIOTIC TO CLEAR IT. SHE WENT INTO SEE THE MD FOR BLADDER IRRIGATION TREATMENT SHE DESCRIBED AS INSTALLATION OF AN ANTIBIOTIC INTRAVESICALLY BUT THEY COULD NOT DO IT AT THE TIME DUE TO THIS UTI AND THEY DID NOT WANT THE MEDICATION TO GO SYSTEMICALLY. SHE HAS HAD TO TAKE MULTIPLE COURSES OF ANTIBIOTICS EVERY TIME SHE GETS AN INFECTION, WHICH AGAIN HAS BEEN MORE FREQUENT OVER THE LAST YEAR WHILE USING THIS CATHETER. SHE SAID ALSO THAT HER MD STATES SHE HAS "POCKETS IN HER BLADDER" AND THE CONDITION OF THE LINING OF HER BLADDER PLACES HER AT RISK FOR UTI. SHE OFTEN MOVES HERSELF AND THE CATHETER AS SHE CATHS TO MAKE SURE SHE GETS ALL THE URINE OUT

  Patient problems: Urinary Tract Infection

  MAUDE report 15264788 ↗

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 (