CURE CATHETER HM14Recalls & reported problems
Convatec, Purchasing Department · Hydrophilic, Male, 16”, Straight Tip · Class 2
All models of CURE CATHETER (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec CURE catheter is a hydrophilic straight-tip catheter used to drain urine. Its 154 reports mostly describe the catheter being hard to pull from its packaging, and some describe rough or sharp edges and urinary tract infections after use. The reports include no deaths and 27 injuries, and 127 are malfunctions. No recalls name this device. Reports dropped from 22 in the year before to 2 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 154
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00815947020314), received between Sep 15, 2017 and Feb 25, 2026 — classified as 27 injuries, 127 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (105 reports).
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove105
- Adverse Event Without Identified Device or Use Problem22
- Sharp Edges15
- Device Handling Problem2
- Device Misassembled During Manufacturing /Shipping2
- Difficult to Open or Remove Packaging Material2
- Leak/Splash2
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- Urinary Tract Infection27
- Pain20
- Unspecified Tissue Injury13
- Hemorrhage/Blood Loss/Bleeding3
- Hematuria1
- Laceration(s)1
- Tissue Damage1
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2026Material Discolored; Device Handling Problem
END USER REPORT HE "CATHS 5-6 X A DAY. HE SAID ABOUT 5 OR 6 YRS AGO HE SWITCHED TO THIS CATHETER. PRIOR TO THEN HE WAS USING A CATHETER HE HAD TO LUBE PRIOR TO USE AND SAID HE WAS RARELY GETTING UTIS DURING HIS LONG HISTORY OF SELF CATCHING. WHEN HE STARTED USING THIS CATHETER HE SAID HE STARTED GETTING RECURRENT UTIS. HE FEELS LIKE THIS PRODUCTS ONGOING DEFECT OF THIS WHITE MILKY SUBSTANCE IN ONLY SOME, HAS BEEN AN ONGOING ISSUE IN ALL THE YEARS HE HAS USED IT. HE NOTED THIS ISSUE IN MULTIPLE BOXES AND MULTIPLE LOTS EVER SINCE HE STARTED USING THIS PRODUCT AND THINKS IS TO BLAME FOR THOSE UTIS. HE SAID SOMETIMES A QUARTER OF A BOX IS AFFECTED AT A TIME. HE SAID AFTER HE BURSTS THE WATER SACHET TO PREP THEM, HE WILL FIND VARIOUS AMOUNTS SOMETIMES UP TO 1 INCH OF "WHITE MILKY" SUBSTANCE IN THE CATHETER TUBING ITSELF. HE CAN SEE IT BEFORE IT IS EVER PLACED IN HIM AND CAN SEE IT IN THE CATHETER WHEN HE REMOVES IT FROM THE PACKAGING. HE SAID THEY WILL STILL DRAIN HIS BLADDER EVEN WITH THIS SUBSTANCE BUT NOTES IT THERE PRIOR TO INSERTION AND THEN UPON REMOVAL TOO. HE NEVER CHECKED THE CATHETER PRIOR TO BURSTING THE WATER SACHET TO SEE IF ANYTHING WAS IN THE CATHETER BEFORE." HE SAID YEA
Patient problems: Urinary Tract Infection
MAUDE report 24445569 ↗InjuryFeb 25, 2026Material Discolored; Device Handling Problem
END USER REPORT HE "CATHS 5-6 X A DAY. HE SAID ABOUT 5 OR 6 YRS AGO HE SWITCHED TO THIS CATHETER. PRIOR TO THEN HE WAS USING A CATHETER HE HAD TO LUBE PRIOR TO USE AND SAID HE WAS RARELY GETTING UTIS DURING HIS LONG HISTORY OF SELF CATHING. WHEN HE STARTED USING THIS CATHETER HE SAID HE STARTED GETTING RECURRENT UTIS. HE FEELS LIKE THIS PRODUCTS ONGOING DEFECT OF THIS WHITE MILKY SUBSTANCE IN ONLY SOME, HAS BEEN AN ONGOING ISSUE IN ALL THE YEARS HE HAS USED IT. HE NOTED THIS ISSUE IN MULTIPLE BOXES AND MULTIPLE LOTS EVER SINCE HE STARTED USING THIS PRODUCT AND THINKS IS TO BLAME FOR THOSE UTIS. HE SAID SOMETIMES A QUARTER OF A BOX IS AFFECTED AT A TIME. HE SAID AFTER HE BURSTS THE WATER SACHET TO PREP THEM, HE WILL FIND VARIOUS AMOUNTS SOMETIMES UP TO 1 INCH OF "WHITE MILKY" SUBSTANCE IN THE CATHETER TUBING ITSELF. HE CAN SEE IT BEFORE IT IS EVER PLACED IN HIM AND CAN SEE IT IN THE CATHETER WHEN HE REMOVES IT FROM THE PACKAGING. HE SAID THEY WILL STILL DRAIN HIS BLADDER EVEN WITH THIS SUBSTANCE BUT NOTES IT THERE PRIOR TO INSERTION AND THEN UPON REMOVAL TOO. HE NEVER CHECKED THE CATHETER PRIOR TO BURSTING THE WATER SACHET TO SEE IF ANYTHING WAS IN THE CATHETER BEFORE." HE SAID YEAR
Patient problems: Urinary Tract Infection
MAUDE report 24445562 ↗MalfunctionJul 3, 2025Sharp Edges; Sharp Edges
END USER REPORTS THE EYELITS ARE ROUGH TO INSERT AND END USER IS GETTING UTIS. END USER DID NOT SPECIFY THE QUANTITY AFFECTED AND HAS USED THIS PRODUCT BEFORE. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO AVAILABLE.
Patient problems: Urinary Tract Infection
MAUDE report 22395005 ↗MalfunctionMay 21, 2025Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material
END USER REPORTS "CATHS STICKING TO THE INSIDE OF THE PACKAGING, AND TEARING THE PACKAGING AWAY WITH THE CATH WHEN PULLED OUT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061734 ↗MalfunctionMay 21, 2025Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material
END USER REPORTS "CATHS STICKING TO THE INSIDE OF THE PACKAGING, AND TEARING THE PACKAGING AWAY WITH THE CATH WHEN PULLED OUT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061733 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER REPORTS UTI DIAGNOSED SHORTLY AFTER USE. CONSUMER IS NOT NEW TO THIS PRODUCT, HAS BEEN USING IT FOR A LONG TIME AND IT HAS ALWAYS WORKED WELL FOR HIM. HE CATHS TYPICALLY 2-3 TIMES A DAY RECENTLY SWITCHED TO 4 TIMES DAY FOR RETENTION. HE HAS HISTORY OF A BLADDER DIVERTICULUM AND ONE NON-FUNCTIONING KIDNEY. HE HAD SURGERY TO REMOVE BOTH IN THE PAST. HE SAID HIS URINE BEGAN TO BE MALODOROUS AND HE DIDN'T FEEL GOOD AND HAD A LOW-GRADE FEVER SO HE WENT TO URGENT CARE AND THEY DID URINE TESTING AND HIS URINE CULTURE GREW OUT KLEBSIELLA. HE SAID HE HAS HAD THIS BACTERIA BEFORE IN THE PAST BUT HE HAS NOT HAD A UTI IN LONG WHILE. HE WAS PRESCRIBED KEFLEX AS WELL AS A PROBIOTIC TO HELP WITH CONSTIPATION AND THIS HAS HELPED HIM, FEELING BETTER NOW.
Patient problems: Urinary Tract Infection
MAUDE report 21968163 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER REPORTS UTI DIAGNOSED SHORTLY AFTER USE. CONSUMER IS NOT NEW TO THIS PRODUCT, HAS BEEN USING IT FOR A LONG TIME AND IT HAS ALWAYS WORKED WELL FOR HIM. HE CATHS TYPICALLY 2-3 TIMES A DAY RECENTLY SWITCHED TO 4 TIMES DAY FOR RETENTION. HE HAS HISTORY OF A BLADDER DIVERTICULUM AND ONE NON-FUNCTIONING KIDNEY. HE HAD SURGERY TO REMOVE BOTH IN THE PAST. HE SAID HIS URINE BEGAN TO BE MALODOROUS AND HE DIDN'T FEEL GOOD AND HAD A LOW-GRADE FEVER SO HE WENT TO URGENT CARE AND THEY DID URINE TESTING AND HIS URINE CULTURE GREW OUT KLEBSIELLA. HE SAID HE HAS HAD THIS BACTERIA BEFORE IN THE PAST BUT HE HAS NOT HAD A UTI IN LONG WHILE. HE WAS PRESCRIBED KEFLEX AS WELL AS A PROBIOTIC TO HELP WITH CONSTIPATION AND THIS HAS HELPED HIM, FEELING BETTER NOW.
Patient problems: Urinary Tract Infection
MAUDE report 21902011 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER REPORTS RECENT UTI WITH USE OF PRODUCT. HE FURTHER STATES HE WAS RECENTLY IN THE HOSPITAL FOR HEART CONCERNS, PLACED ON MULTIPLE ANTIBIOTICS TO GO HOME WITH HE SAID BUT JUST TODAY GOT CALLED IN AN ALTERNATIVE ANTIBIOTIC FOR A UTI THAT GREW OUT IN HIS URINE CULTURE AND WAS FINALIZED TODAY. HE SAID HIS URINE IS DARK AND THAT IS HIS ONLY SYMPTOM DESPITE HIM PUSHING FLUIDS. HE SAID HE HAS HAD MULTIPLE UTIS IN THE PAST BUT THAT IS USUALLY WHENEVER HE RUNS OUT OF THIS CATHETER AND HAS TO PURCHASE OUT OF POCKET UNCOATED CATHETERS HE HAS TO APPLY LUBRICANT TO.
Patient problems: Urinary Tract Infection
MAUDE report 21360696 ↗InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER REPORTS HE WAS "DIAGNOSED WITH ORCHITIS ¿ NOT A UTI AND HE SAID THE DOCTORS COULDN¿T PINPOINT IF THE CAUSE OF IT WAS IN ANY WAY CONNECTED TO HIS CIC HOWEVER THEY ADVISED HIM TO USE A BETTER TECHNIQUE WITH PERFORMING CIC AS HE SAID HE WOULD NEVER CLEANSE HIS MEATUS PRIOR TO INSERTION. HE SAID HE STAYED IN THE HOSPITAL FOR 4 DAYS AND NEEDED IV ANTIBIOTICS AND GOING HOME - ORAL ANTIBIOTICS AND PAIN MEDICINES AND HE SAID OVERALL FEELING MUCH BETTER. HE ALSO SAID HE WAITED TOO LONG LIKE 3-4 DAYS BEFORE LETTING HIS MD KNOW ABOUT HIS DISCOMFORT PRIOR TO ADMISSION. HE SAID 1 OUT OF EVERY 600-700, SO VERY RARE HE SAID, HE WILL NOTICE THAT THE GRIPPER SLEEVE IS MELTED AND STUCK INTO THE SIDE SEAL OF THE PACKAGING. HE NOTES THE NO TOUCH SLEEVE IS STUCK ONLY WHEN TRYING TO REMOVE THE CATHETER FROM THE PACKAGING AFTER BURSTING THE WATER SACHET AS HE NORMALLY DOES. HE DOES NOT USE THESE WHEN HE FINDS THEM LIKE THIS AND DISCARDS THEM."
Patient problems: Pain; Urinary Tract Infection
MAUDE report 20818782 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766297 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766296 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766295 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766294 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766291 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766290 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766289 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766288 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766283 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766282 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766281 ↗MalfunctionNov 23, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20766279 ↗MalfunctionNov 22, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20765221 ↗MalfunctionNov 22, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20765171 ↗MalfunctionNov 22, 2024Difficult to Remove; Difficult to Remove
END USER REPORTED USING 15 OF 30 CATHETERS THAT 'ALL FEEL LIKE THEY ARE STICKING THE LENGTH OF HIS URETHRA UPON REMOVAL'. HE STATED HE ORDERED THESE FROM HIS SUPPLIER AND REPORTS THESE FROM THIS BOX ALL FEEL LIKE THEY ARE STICKING UPON REMOVAL FROM HIS URETHRA. ADDITIONALLY, HE STATED HE FEELS THIS THE LENGTH OF HIS URETHRA UPON REMOVAL AND ESPECIALLY NOTED BY THE UPPER PORTION OF CATHETER NEAR THE FUNNEL. HE REPORTED THIS "STICKING" UPON REMOVAL AT MOST CREATES DISCOMFORT WITH USE UPON REMOVAL. NO FURTHER HARM WAS REPORTED.
Patient problems: Pain
MAUDE report 20765164 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CONSUMER STATES "HE STARTED CATHING 4 OR 5 YEARS AGO AFTER BACK SURGERY FOR DEGENERATIVE DISCS AND IT AFFECTED HIS BLADDER ABILITY TO EMPTY. HE HAS ARTHRITIS, RECENT RECURRENT KNEE INFECTIONS ON HIS KNEE REPLACEMENT. NO HISTORY OF BPH, NO HISTORY OF KIDNEY STONES. HAS SAID THIS HAS BEEN HIS PREFERRED CATHETER. JUST THIS YEAR HE SAID FOR UNKNOWN REASON OR CAUSE (NOT BLAMING THE CATHETERS) HE HAS BEEN GETTING RECURRENT UTIS, HE SAID "4 OR 5" OF THEM." HE SAID "FOR THIS LAST FLARE UP OF UTI SYMPTOMS LAST WEEK HE SAID HE WAS ON DOXYCYLINE AND AN ANTIBIOTIC THAT STARTS WITH A "C" FOR A RECENT KNEE INFECTION." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE UTIS.
Patient problems: Urinary Tract Infection
MAUDE report 20406774 ↗
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- CURE CATHETER HM16CConvatec, Purchasing Department · Catheter, Straight137 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page