CURE CATHETER M14CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00815947020086), received between Apr 25, 2018 and Jan 24, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED "THE COUDE GUIDE LINES ARE NOT LINED UP WITH THE COUDE TIP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229327 ↗
• MalfunctionJan 9, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED "THE COUDE GUIDELINE IS NOT PROPERLY MATCHED UP WITH THE WITH THE COUDE TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111740 ↗
• MalfunctionSep 23, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Pain

  MAUDE report 20278350 ↗
• MalfunctionApr 2, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  END USER STATES "HE HAS BEEN USING THIS CATHETER FOR YEARS FOR RETENTION FROM BPH AND HE SAID HE LIKES THIS PRODUCT, OVERALL WORKS WELL FOR HIM. CONSUMER SAID SOMETIMES HE NOTICES AT THE VERY TIP THE TIP IT CAN BE A LITTLE "ROUGH AND ABRASIVE." HE SAID HE WILL FEEL THE TIP OF THE CATHETER BEFORE AND/OR AFTER USE JUST TO CHECK IT AND ONLY SOME WILL FEEL "SLIGHTLY ABRASIVE." HE SAID IT IS STILL FEELS "KIND OF SMOOTH" SO HE JUST APPLIES LUBE OVER IT AND USES ONES HE FINDS FEEL THIS WAY. HE SAID SOMETIMES IT CAN "NOT FEEL TOO GOOD A LITTLE DISCOMFORT WITH REMOVAL." DENIES BLEEDING OR PAIN. NO HARM REPORTED. HE THINKS MAYBE SOMETHING DURING THE MANUFACTURING PROCESS DOESN'T POLISH THESE AS WELL AS OTHERS AND JUST WANTED US TO BE AWARE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018392 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER RELAYED HE HAS HAD UTIS WITH USE OF THE M14C, HAS USED UNKNOWN QTY, UNKNOWM MUS, UNKNOWN LOTS OVER THE LAST 10 YEARS, LAST ONE ABOUT A MONTH AGO. CONSUMER CLARIFIED HE DOES NOT THINK THESE CATHETERS DO NOT CAUSE HIS UTIS JUST THAT THEY OCCUR PERIODICALLY WITH USE OF THEM. HE SAID HE ONLY TOLD LIBERATOR (WHO REPORTED IT TO US) OF HIS RECENT UTI AS HE SAID HE WANTED MORE QTY OF CATHETERS PER MONTH AS WHEN HE HAS THESE INFECTIONS HE WILL USE 3 CATHETERS PER DAY INSTEAD OF 2. HE SAID HE USUALLY GETS UTIS ABOUT ONCE A YEAR SINCE HE STARTED CATHING AS AN OVERALL RESULT FROM CATHING AND DOES NOT THINK IT IS THE FAULT OF THESE CATHETERS. NOT REPORTING THEM AS DEFECTED IN ANY WAY. THIS YEAR HE HAS HAD MORE UTIS - 2 SEPARATE UTIS " A COUPLE MONTHS APART" LAST ONE BEING A MONTH AGO. HIS ONLY UTI SYMPTOM IS THE FEELING OF FREQUENCY/URGENCY. HE WILL GO TO THIS PCP AND GET A URINE TEST AND THEN BE TREATED WITH ANTIBIOTICS FOR 14 DAYS AND HIS SYMPTOMS GOES AWAY. HE SAID THE LAST UTI HE REPORTED PER THE URINE TESTING WAS A "STAPH INFECTION" IN HIS URINE AND THAT WAS ABOUT A MONTH AGO. HE WAS TREATED WITH ANTIBIOTICS (NAME UNKNOWN) AND SYMPTOMS RESOLVED AS THEY ALWAYS DO AFTER TREATMENT. H

  Patient problems: Urinary Tract Infection

  MAUDE report 17880528 ↗
• InjuryMar 9, 2023Device Handling Problem; Device Handling Problem

  END USER STATES HE WAS RECENTLY DIAGNOSED WITH A UTI WITH BLEEDING/CLOTS WHILE USING THIS M14C CATHETER, QTY UNKNOWN, MU/S UNKNOWN, LOT/S UNKNOWN. HE DOES NOT THINK THE CATHETER IS TO BLAME FOR HIS UTI. HE HAS BEEN CATHING FOR OVER A YEAR HE SAID 3-5 X A DAY FOR RETENTION BECAUSE HIS BLADDER DOESN'T FULLY EMPTY AND HE SAID HE HAS HAD 2 SURGERIES FOR THIS BUT IT HAS NOT HELPED SO THAT IS WHY HE IS CATHING". END USER STATES HE IS NOT NEW TO CATHING AND HAS BEEN USING THIS CATHETER FOR A WHILE. HE STATED VERY CLEARLY (MORE THAN ONCE AND CLARIFIED WITH HIM) THE CATHETER ITSELF IS NOT THE CAUSE OF WHY HE HAD A RECENT UTI AND BLEEDING/CLOTS AND IT WAS HIS TECHNIQUE THAT CAUSED HIS RECENT UTI, SPECIFICALLY HIS LACK OF CLEANLINESS WITH CATHING. END USER STATED "IT IS BECAUSE HE WAS "GOING TO QUICKLY", NOT TAKING THE TIME TO CLEAN HIMSELF PROPERLY PRIOR TO CATHING AND HE WAS JUST RUSHING TO CATH. SPECIFICALLY, HE SAID HE DIDN'T CLEANSE HIS MEATUS PROPERLY PRIOR TO CATHING. HE SAID HE STARTED HIS UTI SYMPTOMS WITH BLEEDING AND HAD LARGE CLOTS AND IT QUICKLY CLOGGED HIS URETHRA SO HE COULD NOT GET CATHETER IN AND HE COULD NOT GET URINE OUT/ WENT INTO RETENTION. HE WENT TO ER WHERE THEY FLUSHE

  Patient problems: Urinary Tract Infection

  MAUDE report 16512494 ↗
• InjurySep 8, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS AN "UNKNOWN NUMBER OF M14C CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST YEAR WHEN HE HAS HAD 3 UTIS. CURRENT MARKET UNIT WITH LOT #220303-1. CONSUMER IS NOT SURE IF CATHETERS ARE CAUSING HIS UTIS, HE SAID RECENTLY HE HAS HAD ABOUT 3 IN THE PAST YEAR. HE HAS USED THE M14C FOR A VERY LONG TIME AND CONFIRMS HE HAS BEEN USING THEM ALL THIS YEAR WHEN HIS UTIS OCCURRED. HE SAID HIS CONDITION OF MS CAUSES HIM TO HAVE A COMPROMISED IMMUNE SYSTEM PUTTING HIM FURTHER AT RISK FOR UTIS. HE CATHS 4X A DAY FOR THE PAST 20 YRS. HIS UTI SYMPTOMS ARE CLOUDY URINE AND SAID HIS WHOLE BODY SYSTEMS DUE TO MS ARE AFFECTED, OVERALL DOESN'T FEEL WELL. HE SAID HE RECENTLY WENT TO GET HIS URINE TESTED, AS HE HAS A STANDING ORDER HIS MD PLACED FOR HIM AT THE LAB FOR UA AND URINE CULTURE WHEN HE FEELS A UTI COMING ON. TOMORROW IS HIS LAST DAY OF THE ANTIBIOTIC HE IS CURRENTLY TAKING, NAME UNKNOWN, FOR A UTI HE WAS DIAGNOSED WITH RECENTLY. HE SAID THE TIME PRIOR TO THIS HE ACTUALLY ENDED UP ADMITTED FOR 11 DAYS IN THE HOSPITAL AS HE WENT INTO SEPTIC SHOCK FROM A UTI. HE SAID THIS TIME HE CAUGHT IT IN TIME." CATHETERIZATION TECHNIQUE WAS

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 15378709 ↗
• InjurySep 8, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS AN "UNKNOWN NUMBER OF M14C CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST YEAR WHEN HE HAS HAD 3 UTIS. CURRENT MARKET UNIT WITH LOT #220303-1. CONSUMER IS NOT SURE IF CATHETERS ARE CAUSING HIS UTIS, HE SAID RECENTLY HE HAS HAD ABOUT 3 IN THE PAST YEAR. HE HAS USED THE M14C FOR A VERY LONG TIME AND CONFIRMS HE HAS BEEN USING THEM ALL THIS YEAR WHEN HIS UTIS OCCURRED. HE SAID HIS CONDITION OF MS CAUSES HIM TO HAVE A COMPROMISED IMMUNE SYSTEM PUTTING HIM FURTHER AT RISK FOR UTIS. HE CATHS 4X A DAY FOR THE PAST 20 YRS. HIS UTI SYMPTOMS ARE CLOUDY URINE AND SAID HIS WHOLE BODY SYSTEMS DUE TO MS ARE AFFECTED, OVERALL DOESN'T FEEL WELL. HE SAID HE RECENTLY WENT TO GET HIS URINE TESTED, AS HE HAS A STANDING ORDER HIS MD PLACED FOR HIM AT THE LAB FOR UA AND URINE CULTURE WHEN HE FEELS A UTI COMING ON. TOMORROW IS HIS LAST DAY OF THE ANTIBIOTIC HE IS CURRENTLY TAKING, NAME UNKNOWN, FOR A UTI HE WAS DIAGNOSED WITH RECENTLY. HE SAID THE TIME PRIOR TO THIS HE ACTUALLY ENDED UP ADMITTED FOR 11 DAYS IN THE HOSPITAL AS HE WENT INTO SEPTIC SHOCK FROM A UTI. HE SAID THIS TIME HE CAUGHT IT IN TIME." CATHETERIZATION TECHNIQUE WAS

  Patient problems: Urinary Tract Infection

  MAUDE report 15378350 ↗
• InjurySep 8, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS AN "UNKNOWN NUMBER OF M14C CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST YEAR WHEN HE HAS HAD 3 UTIS. CURRENT MARKET UNIT WITH LOT #220303-1. CONSUMER IS NOT SURE IF CATHETERS ARE CAUSING HIS UTIS, HE SAID RECENTLY HE HAS HAD ABOUT 3 IN THE PAST YEAR. HE HAS USED THE M14C FOR A A VERY LONG TIME AND CONFIRMS HE HAS BEEN USING THEM ALL THIS YEAR WHEN HIS UTIS OCCURRED. HE SAID HIS CONDITION OF MS CAUSES HIM TO HAVE A COMPROMISED IMMUNE SYSTEM PUTTING HIM FURTHER AT RISK FOR UTIS. HE CATHS 4X A DAY FOR THE PAST 20 YRS. HIS UTI SYMPTOMS ARE CLOUDY URINE AND SAID HIS WHOLE BODY SYSTEMS DUE TO MS ARE AFFECTED, OVERALL DOESN'T FEEL WELL. HE SAID HE RECENTLY WENT TO GET HIS URINE TESTED, AS HE HAS A STANDING ORDER HIS MD PLACED FOR HIM AT THE LAB FOR UA AND URINE CULTURE WHEN HE FEELS A UTI COMING ON. TOMORROW IS HIS LAST DAY OF THE ANTIBIOTIC HE IS CURRENTLY TAKING, NAME UNKNOWN, FOR A UTI HE WAS DIAGNOSED WITH RECENTLY. HE SAID THE TIME PRIOR TO THIS HE ACTUALLY ENDED UP ADMITTED FOR 11 DAYS IN THE HOSPITAL AS HE WENT INTO SEPTIC SHOCK FROM A UTI. HE SAID THIS TIME HE CAUGHT IT IN TIME." CATHETERIZATION TECHNIQUE WA

  Patient problems: Urinary Tract Infection

  MAUDE report 15378276 ↗
• InjuryJul 7, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS "EXPERIENCED BLEEDING ON AND OFF FOR 3 WEEKS, WORSENING NOW WITH UTI SYMPTOMS WITH USE OF M14C CATHETER REUSING SAME 2 CATHETERS FROM UNKNOWN MU/S, UNKNOWN LOT #. CONSUMER EXTREMELY FRUSTRATED WITH HER CURRENT SUPPLIER STATING SHE HASN'T RECEIVED LAST SHIPMENT OF CATHETERS AND FOR LAST 3 WEEKS AND SHE HAS HAD TO WASH AND RE-USE THE SAME 2 CATHETERS OVER AND OVER AGAIN. SHE SAID SHE HAD BOILED THEM TO STERILIZE THEM BUT IT RUINS THE CATHETER AND SO SHE HAD BEEN JUST RUNNING IT UNDER HOT WATER TO CLEAN IT. SHE DOES NOT ALLEGE A PRODUCT DEFECT AND HAS BEEN USING THESE CATHETERS WITHOUT CONCERNS FOR MANY YEARS SHE SAID CATHING 5 X A DAY AS SHE WAS BORN WITH SPINA BIFIDA. SHE SAID SHE HAS BEEN USING A SIZE 14 FR MALE CATHETER WITH COUDE TIP FOR YEARS, THIS IS NOT SOMETHING NEW. SHE STATES HER SUPPLIER DID NOT RECEIVE THE DOCUMENTATION NEEDED TO JUSTIFY COUDE TIP SO INSURANCE WOULD COVER THEM FOR HER LAST RE-ORDER. SHE SAID SHE HAS CONTACTED HER DOCTOR AND THEY HAVE TOLD HER THEY HAVE SENT OVER THE DOCUMENTATION. SHE STATES THAT THE SUPPLIER REP WAS TELLING HER NEED FOR COUDE WAS NEW WHEN SHE SAID SHE HAS BEEN USING COUDE TIP CATHETERS FOR 35 YRS AND FOR THE FULL 11 YEAR

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 14943928 ↗
• MalfunctionJun 22, 2022Sharp Edges; Sharp Edges

  CONSUMER CALLED IN TO REPORT "A SHARP EDGE" ON THE CATHETER. CONSUMER SAID "IS TYPICAL CATHING ROUTINE IS WASHING HIS HANDS THEN CHECKING HIS CATHETER BY RUNNING HIS CLEAN WET HAND HAND DOWN THE LENGTH OF IT TO CHECK IT PRIOR TO PLACING LUBE AND INSERTING. HE SAID HE RECENTLY FOUND ONE OF THE M14C CATHETERS THAT HAS A "STRANGE SHARP EDGE, ABOUT ONE AND A QUARTER INCHES FROM THE TIP." HE SAID "THE FLAW IS RIGHT ON THE BLUE GUIDE LINE." HE SAID IT "FELT LIKE SOMEONE GLUED A GRAIN OF SAND ON IT". HE WAS ABLE TO HOLD THE CATHETER UP TO THE LIGHT WHILE WE SPOKE AND SAID HE COULD SEE A LITTLE BUMP LIKE A "MICRO BUBBLE ON THE BLUE GUIDE LINE." HE SAID WHEN HE NOTED THIS PRIOR TO USE, HE DID NOT USE IT CONCERNED IT WOULD BE VERY PAINFUL OR "PUT ME (HIM) IN THE HOSPITAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14773495 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (USER) STATES HE EXPERIENCED AN URINARY TRACT INFECTION BECAUSE HE REUSED SOME OF THE CATHETERS. PATIENT'S DOCTOR INSTRUCTED HIM NOT TO DO THIS. PATIENT RECEIVED ANTIBIOTICS AND HAS RECOVERED.

  Patient problems: Urinary Tract Infection

  MAUDE report 7463244 ↗

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 (