CURE CATHETERRecalls & reported problems across all models
Convatec, Purchasing Department · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 862
- Deaths reported
- 0
- Injuries reported
- 139
- Recalls
- 0
We found 25 models of CURE CATHETER by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 862 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2017 and Jun 9, 2026 — classified as 139 injuries, 723 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (222 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CURE CATHETER problems
Device problems
- Sharp Edges222
- Difficult to Remove200
- Adverse Event Without Identified Device or Use Problem89
- Tear, Rip or Hole in Device Packaging45
- Difficult to Open or Remove Packaging Material42
- Difficult to Open or Close41
- Material Fragmentation41
- Unsealed Device Packaging41
Patient problems
- No Clinical Signs, Symptoms or Conditions481
- Pain138
- Urinary Tract Infection135
- Hemorrhage/Blood Loss/Bleeding49
- Unspecified Tissue Injury47
- Discomfort16
- Hematuria14
- Fever4
CURE CATHETER models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CURE CATHETER HM14Catheter, Straight154 reports
- CURE CATHETER HM16CCatheter, Straight137 reports
- CURE CATHETER HM14CCatheter, Straight118 reports
- CURE CATHETER M16CCatheter, Urethral95 reports
- CURE CATHETER M14Catheter, Straight83 reports
- CURE CATHETER HM12CCatheter, Straight74 reports
- CURE CATHETER M16Catheter, Straight67 reports
- CURE CATHETER HM16Catheter, Straight46 reports
- CURE CATHETER HM12Catheter, Straight27 reports
- CURE CATHETER M14CCatheter, Urethral12 reports
- CURE CATHETER F14NCCatheter, Straight9 reports
- CURE CATHETER F14Catheter, Straight7 reports
- CURE CATHETER M12CCATHETER, STRAIGHT6 reports
- CURE CATHETER M12Catheter, Straight5 reports
- CURE CATHETER M14UCatheter, Straight4 reports
- CURE CATHETER M18Catheter, Straight3 reports
- CURE CATHETER HM14UKCATHETER, UROLOGICAL3 reports
- CURE CATHETER M8Catheter, Straight2 reports
- CURE CATHETER F16Catheter, Straight2 reports
- CURE CATHETER HP8Catheter, Straight2 reports
- CURE CATHETER HM18CCatheter, Straight2 reports
- CURE CATHETER M10Catheter, Straight1 report
- CURE CATHETER P14Catheter, Straight1 report
- CURE CATHETER M14UKCATHETER, STRAIGHT1 report
- CURE CATHETER HP12Catheter, Straight1 report
Recent CURE CATHETER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Contamination /Decontamination Problem
To date no additional patient or event details have been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25445526 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
(B)(6) YEAR OLD END USER REPORTS HE HAS HAD "INFECTIONS IN THE BLADDER" IN HIS PAST AND HIS DOCTOR HAS NEEDED TO GIVE HIM MEDICINE FOR AT TIME BUT DOESN'T KNOW IF POSSIBLY THIS COULD BE CAUSED BY USING CATHETERS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 25378462 ↗MalfunctionMay 7, 2026Packaging Problem
END USER REPORTS PAPER THIN AND RIPPING WITH UNKNOWN QTY, FROM UNKNOWN MUS AND UNKNOWN LOTS. ADDITIONALLY REPORTS PAPER THIN AND RIPPING WITH THE MAJORITY OF CATHETERS (UNKNOWN QTY) FROM CURRENT MU'S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117742 ↗MalfunctionMay 7, 2026Packaging Problem
END USER REPORTS WATER SACHET STICKING IN PACKAGING AND RIPPING PAPER WITH CURRENT 2 MU'S. HE REPORTS MAJORITY OF CATHETERS (UNKNOWN QTY) AFFECTED. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED. THIS EMDR IS TO ADDRESS THE UNKNOWN MARKET UNITS/LOT #'S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117701 ↗MalfunctionMay 7, 2026Packaging Problem
END USER REPORTS WATER SACHET STICKING IN PACKAGING AND RIPPING PAPER WITH CURRENT 2 MU'S. HE REPORTS MAJORITY OF CATHETERS (UNKNOWN QTY) AFFECTED. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117693 ↗MalfunctionMay 6, 2026Packaging Problem
END USER REPORTS PAPER THIN AND RIPPING WITH UNKNOWN QTY, FROM UNKNOWN MUS AND UNKNOWN LOTS. ADDITIONALLY REPORTS PAPER THIN AND RIPPING WITH THE MAJORITY OF CATHETERS (UNKNOWN QTY) FROM CURRENT MU'S. THIS EMDR IS TO ADDRESS THE UNKNOWN MARKET UNITS/LOT # S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095588 ↗InjuryApr 15, 2026Device Handling Problem
CONSUMER'S WIFE REPORTS HER HUSBAND HAS HAD "MULTIPLE UTIS IN THE 13 YRS HE HAS USED THIS PRODUCT." SHE STATES HE "HAS HAD UTIS OVER THE YEARS HE HAS CATHED BUT THEY WERE NOT OFTEN. STARTING THIS PAST ON (B)(6) 2025, IS WHEN THEY BECAME RECURRENT. HE RECENTLY HAD A CT WITH CONTRAST WHICH FOUND A DIVERTICULUM AND HE IS GOING TO DISCUSS THIS WITH HIS UROLOGIST AT AN UPCOMING APPT LATER THIS MONTH. MOST RECENTLY OF THIS PAST TUESDAY HIS INTERNIST CHECKED HIS URINE AS HE STATED IT LOOKED VERY "TRASHY" AND THEY FOUND >100CFU OF KLEBSIELLA IN THE URINE CULTURE. HE IS ON A TREATMENT COURSE RIGHT NOW OF KEFLEX FOR 5 DAYS. PRIOR TO DECEMBER WIFE STATES HE HAS HAD MULTIPLE UTIS WITH VARIOUS BACTERIA NOTING A >100 CFU OF ENTEROCOCCUS UTI IN MARCH AND IN FEBRUARY HAD A >100K OF PSEUDOMONAS INFECTION SHE ACTUALLY ADMINISTERED IV ANTIBIOTICS TO HIM FOR 7 DAYS OF MEROPENEM. SHE STATES SINCE DEC - MARCH HE HAS BEEN ON VARIOUS TREATMENT DOSES FROM 5- 7 DAYS OF EITHER MACROBID, KEFLEX AND AMPICILLIN. DURING THAT TIME WAS ALSO ON A LOW DOSE 20 DAY ANTIBIOTIC TREATMENT DOSE (NAME UNKNOWN). HE GETS RELIEF BUT THEN TYPICALLY JUST 4 DAYS OR SO LATER BEING OFF ANTIBIOTICS, HE GETS SYMPTOMATIC ONCE AGAIN.
Patient problems: Urinary Tract Infection
MAUDE report 24886235 ↗InjuryApr 15, 2026Device Handling Problem
CONSUMER'S WIFE REPORTS HER HUSBAND HAS HAD "MULTIPLE UTIS IN THE 13 YRS HE HAS USED THIS PRODUCT." SHE STATES HE "HAS HAD UTIS OVER THE YEARS HE HAS CATHED BUT THEY WERE NOT OFTEN. STARTING THIS PAST ON (B)(6) 2025, IS WHEN THEY BECAME RECURRENT. HE RECENTLY HAD A CT WITH CONTRAST WHICH FOUND A DIVERTICULUM AND HE IS GOING TO DISCUSS THIS WITH HIS UROLOGIST AT AN UPCOMING APPT LATER THIS MONTH. MOST RECENTLY OF THIS PAST TUESDAY HIS INTERNIST CHECKED HIS URINE AS HE STATED IT LOOKED VERY "TRASHY" AND THEY FOUND >100CFU OF KLEBSIELLA IN THE URINE CULTURE. HE IS ON A TREATMENT COURSE RIGHT NOW OF KEFLEX FOR 5 DAYS. PRIOR TO DECEMBER WIFE STATES HE HAS HAD MULTIPLE UTIS WITH VARIOUS BACTERIA NOTING A >100 CFU OF ENTEROCOCCUS UTI IN MARCH AND IN FEBRUARY HAD A >100K OF PSEUDOMONAS INFECTION SHE ACTUALLY ADMINISTERED IV ANTIBIOTICS TO HIM FOR 7 DAYS OF MEROPENEM. SHE STATES SINCE DEC - MARCH HE HAS BEEN ON VARIOUS TREATMENT DOSES FROM 5- 7 DAYS OF EITHER MACROBID, KEFLEX AND AMPICILLIN. DURING THAT TIME WAS ALSO ON A LOW DOSE 20 DAY ANTIBIOTIC TREATMENT DOSE (NAME UNKNOWN). HE GETS RELIEF BUT THEN TYPICALLY JUST 4 DAYS OR SO LATER BEING OFF ANTIBIOTICS, HE GETS SYMPTOMATIC ONCE AGAIN.
Patient problems: Urinary Tract Infection
MAUDE report 24886232 ↗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 ↗MalfunctionFeb 19, 2026Sharp Edges
IT WAS REPORTED "CATHETER SHAFTS ARE NOT SMOOTH IN AREAS, THEY HAVE KINKS AND "CRUSTINESS" ON CATHETERS - CAUSED LIGHT BLEEDING WITH USE IN PAST." CONSUMER REPORTS "CATHING FOR RETENTION FOR MANY YEARS, PREVIOUSLY USING THE HM12C BUT THEM SWITCHED TO THE HM12 A FEW MONTHS AGO AS EASIER TO GET THROUGH HIS ANATOMY. HE SAID THIS ISSUE STARTED 2 MONTHS AGO WITH THIS PRODUCT. HE SAID HE WILL PREP THE CATHETERS AS USUAL BY BURSTING THE WATER SACHET AND THEN ENSURING THE WATER GETS ALL OVER THE CATHETER PRIOR TO OPENING THEM. WHEN HE REMOVES THEM FROM THE PACKAGING HE ENSURES THAT THE CATHETERS ARE SMOOTH BY RUNNING UP AND DOWN THE CATHETER THE SLEEVE. HE SAID ON SOME HE WILL FEEL SOME "CRUSTY STUFF" ALONG THE SHAFT AROUND THE MIDDLE OF THE CATHETERS AND CAN FEEL LIKE A LITTLE KINK AT TIMES AS WELL. NOW HE WILL NOT USE THESE IF HE FINDS THIS CONCERN. HE NOTES SOME HAVE TIPS THAT ARE STUCK TO THE PACKAGING ON THESE BUT NOT A BIG ISSUE AS THEY ARE ABLE TO COME LOOSE EASILY AND UNSURE IF THAT COULD BE RELATED TO THIS CONCERN AS WELL. IN THE PAST HE TRIED TO USE A FEW LIKE THIS AND NOTED THEY WERE UNCOMFORTABLE DUE TO THE DEFECT AND HAD VERY LIGHT BLEEDING IN HIS URINE DRAINAGE BUT IT STOPPED
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24387494 ↗MalfunctionFeb 19, 2026Sharp Edges
IT WAS REPORTED "CATHETER SHAFTS ARE NOT SMOOTH IN AREAS, THEY HAVE KINKS AND "CRUSTINESS" ON CATHETERS - CAUSED LIGHT BLEEDING WITH USE IN PAST." CONSUMER REPORTS "CATHING FOR RETENTION FOR MANY YEARS, PREVIOUSLY USING THE HM12C BUT THEM SWITCHED TO THE HM12 A FEW MONTHS AGO AS EASIER TO GET THROUGH HIS ANATOMY. HE SAID THIS ISSUE STARTED 2 MONTHS AGO WITH THIS PRODUCT. HE SAID HE WILL PREP THE CATHETERS AS USUAL BY BURSTING THE WATER SACHET AND THEN ENSURING THE WATER GETS ALL OVER THE CATHETER PRIOR TO OPENING THEM. WHEN HE REMOVES THEM FROM THE PACKAGING HE ENSURES THAT THE CATHETERS ARE SMOOTH BY RUNNING UP AND DOWN THE CATHETER THE SLEEVE. HE SAID ON SOME HE WILL FEEL SOME "CRUSTY STUFF" ALONG THE SHAFT AROUND THE MIDDLE OF THE CATHETERS AND CAN FEEL LIKE A LITTLE KINK AT TIMES AS WELL. NOW HE WILL NOT USE THESE IF HE FINDS THIS CONCERN. HE NOTES SOME HAVE TIPS THAT ARE STUCK TO THE PACKAGING ON THESE BUT NOT A BIG ISSUE AS THEY ARE ABLE TO COME LOOSE EASILY AND UNSURE IF THAT COULD BE RELATED TO THIS CONCERN AS WELL. IN THE PAST HE TRIED TO USE A FEW LIKE THIS AND NOTED THEY WERE UNCOMFORTABLE DUE TO THE DEFECT AND HAD VERY LIGHT BLEEDING IN HIS URINE DRAINAGE BUT IT STOPPED
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24387493 ↗InjuryFeb 8, 2026Adverse 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 24288261 ↗InjuryFeb 4, 2026Device Handling Problem
END USER'S WIFE REPORTS "SHE FOUND THE ULTRAM12C EXTREMELY HARD TO OPEN THE PACKAGING. SHE CATHS HER HUSBAND. SHE STRUGGLES WITH RHEUMATOID ARTHRITIS AS WELL. SHE SAID SHE WAS UNABLE TO TEAR OPEN THE PACKAGING AND HAD TO USE SCISSORS TO OPEN PACKAGING AND THINKS THIS MAY HAVE CONTAMINATED THE CATHETER AND FEELS LIKE THIS COULD HAVE CONTRIBUTED TO A UTI HE WAS DIAGNOSED WITH SHORTLY AFTER TRIALING THESE. SHE COULD REALLY NOT REMEMBER ANY SPECIFIC DETAILS ABOUT THIS UTI AS IN HIS PAST HE HAS HAD SO MANY HE HAS NEEDED ORAL TREATMENT FOR BUT MOST LIKELY THAT WAS THE CASE. HIS UTIS ARE DIAGNOSED BY CATH'D SPECIMEN SHE BRINGS TO LAB WITH MD ORDER."
Patient problems: Urinary Tract Infection
MAUDE report 24259674 ↗InjuryFeb 4, 2026Device Handling Problem
END USER'S WIFE REPORTS "SHE FOUND THE ULTRAM12C EXTREMELY HARD TO OPEN THE PACKAGING. SHE CATHS HER HUSBAND. SHE STRUGGLES WITH RHEUMATOID ARTHRITIS AS WELL. SHE SAID SHE WAS UNABLE TO TEAR OPEN THE PACKAGING AND HAD TO USE SCISSORS TO OPEN PACKAGING AND THINKS THIS MAY HAVE CONTAMINATED THE CATHETER AND FEELS LIKE THIS COULD HAVE CONTRIBUTED TO A UTI HE WAS DIAGNOSED WITH SHORTLY AFTER TRIALING THESE. SHE COULD REALLY NOT REMEMBER ANY SPECIFIC DETAILS ABOUT THIS UTI AS IN HIS PAST HE HAS HAD SO MANY HE HAS NEEDED ORAL TREATMENT FOR BUT MOST LIKELY THAT WAS THE CASE. HIS UTIS ARE DIAGNOSED BY CATH'D SPECIMEN SHE BRINGS TO LAB WITH MD ORDER."
Patient problems: Urinary Tract Infection
MAUDE report 24259672 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
- ESTEEM SYNERGY9 models · 241 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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