CURE TWISTRecalls & reported problems across all models

We found 4 models of CURE TWIST by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2018 and Mar 9, 2026 — classified as 41 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (6 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

Most reported CURE TWIST problems

CURE TWIST models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CURE TWIST T14

  Catheter, Urological
  30 reports
• CURE TWIST T12

  Catheter, Urological
  8 reports
• CURE TWIST T10

  Catheter, Urological
  4 reports
• CURE TWIST T16

  Catheter, Urological
  1 report

Recent CURE TWIST adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 9, 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 24547730 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE HAS HAD MULTIPLE UTIS WITH USE OF THIS PRODUCT. SHE STATES SHE HAS HAD MULTIPLE UTIS IN THE PAST WITH USE OF THIS PRODUCT. CONSUMER IS A 75-YR OLD T3 SCI PARALYZED FEMALE IN WHEELCHAIR. SUFFERS FROM ARTHRITIS AS WELL. SHE STATES SHE CATHS 3 - 5 TIMES A DAY. SHE HAS USED THIS PRODUCT FOR ABOUT 9 - 10 YRS SHE ESTIMATES. SHE SAID, HOWEVER, SHE STARTED CIC ABOUT 15 YRS AGO AND EVER SINCE SHE STARTED SELF CATHETERIZATION SHE HAS HAD UTIS. HER UNDERSTANDING FROM HER DOCTOR IS BECAUSE SHE CATHETERIZES SHE IS MORE PRONE TO UTIS. SHE CANNOT QUANTITY EXACTLY HOW MANY SHE HAS HAD OVER THE YEARS BUT SHE SAID IT HAS BEEN MANY. SHE SAID SHE ALWAYS TAKES PRECAUTIONS TO WASH HER HANDS, USES ADULT CLEANSING WIPES IN HER GENITAL AREA TO CLEANSE URETHRA AND ENSURES TO NOT CONTAMINATE THE CATHETER BUT SHE IS PRONE TO THEM. SHE SAID IN THE REMOTE PAST HER WORST UTI SHE WAS HOSPITALIZED FOR A FEW DAYS DUE TO AN E. COLI INFECTION FOUND IN HER URINE THAT MADE HER SEPTIC. SHE SAID CURRENTLY SHE HAS A UTI THAT WAS FOUND VIA URINE CULTURE. SHE SAID HER SYMPTOMS ARE TYPICALLY USUALLY LOWER BACK PAINS, TIRED FEELING. SHE HAS COMPLETED 10 DAYS OF AN ANTIBIOTIC PILL (NAME CNO) SHE HAS HAD TO

  Patient problems: Urinary Tract Infection

  MAUDE report 23406145 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "SOME CAPS, SHE CANNOT EVEN GET OPEN, THEY WILL NOT TURN AT ALL AND HAS EVEN ASKED HELP FROM HER SISTER WHO ALSO CANNOT EVEN GET SOME OPEN AND THEY HAVE TO DISCARD WITHOUT USING THEM. SOME OPEN EASILY (AS SHE IS USED TO WITH THIS PRODUCT, DESPITE NOT HAVING THE BEST HAND DEXTERITY) AND OTHERS ARE IMPOSSIBLE TO OPEN HAVING TO STRUGGLE WITH THEM TO GET THEM TO OPEN. SHE SAID SHE ISN'T SURE IF THIS CAUSED IT BUT SHE WAS DIAGNOSED WITH UTI THIS PAST WEEK USING THESE. SHE SAID SHE HASN'T HAD A UTI IN A COUPLE YEARS AND LAST WEEK STARTED TO HAVE FREQUENCY, HER BACK STARTED TO HURT AND SHE FELT "MISERABLE." SHE DID A URINE SAMPLE AS ORDERED BY HER MD AND A UTI WAS CONFIRMED. SHE WAS STARTED ON AN ANTIBIOTIC AND THEN SWITCHED TO A DIFFERENT ONE (NAME/S UNKNOWN WHEN THE URINE CULTURE CAME BACK AND IS ONLY ON DAY 2 OF TAKING THAT NEW TREATMENT COURSE. SHE STATES SHE ALWAYS WASHES HER HANDS, USES 2- 3 WIPES TO CLEANSE HER URETHRA WITH PRIOR TO INSERTION EACH TIME AND ENSURES THE CATHETER STAYS STERILE PRIOR TO USE."

  Patient problems: Urinary Tract Infection

  MAUDE report 23050433 ↗
• MalfunctionAug 28, 2025Product Quality Problem; Product Quality Problem

  "PER CUSTOMER THE CATHETER HAS NO LUBRICATION, THEY WERE DRY." NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911060 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES SHE HAS BEEN CATHING "FOR THE PAST 2 YRS FOR RETENTION 4-5 TIMES A DAY FOLLOWING A COMPLICATION FROM BACK SURGERY WHICH AFFECTED HER BLADDER. SHE SAID SHE HAS BEEN USING THE TWIST FOR 2 YEARS NOW AND IT ALWAYS PREVIOUSLY WORKED WELL FOR HER, HER PREFERRED CATHETER AND HAS USES BOTH T10S AND SIZE T12." SHE FEELS LIKE SOMETHING HAS CHANGED WITH THE PRODUCT POSSIBLY THE LUBE. SHE WAS ASKED "MULTIPLE TIMES IF SHE HAS NOTICED ANYTHING DIFFERENT HERSELF VISUALLY WITH THE PRODUCT AND SHE JUST SAID IT IS ONLY A FEELING OF BURNING AND CLOUDY URINE SHE HAS EXPERIENCED SHORTLY AFTER STARTING USE OF THE NEWER LOTS/ BOXES FROM VARIOUS NEW SUPPLIERS FOR HER. SHE SAID SINCE PERSONALLY DELIVERED WENT OUT OF BUSINESS SHE BOUGHT SOME BOXES FROM DISCOUNT CATHETERS AND NOTICED THAT THE BOX CHANGED FROM SAYING MANUFACTURED FOR NEWPORT BEACH TO CONVATEC. SHE SAID IT IS WITH THESE NEWER CATHETERS SHE STARTED HAVING THE ISSUE. SHE SAID SHE STARTED USING ONE OF THESE NEW BOXES AND SHORTLY THEREAFTER STARTED NOTICING CLOUDY URINE AND BURNING. SHE SAID SHE WENT TO HER DOCTOR AND THEY DID URINE TESTING ON HER AND IT WAS POSITIVE FOR UTI AND SHE WAS GIVEN 7 DAYS OF ANTIBIOTICS WHICH DID CLEAR U

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 22344424 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS CLOUDY URINE AFTER USE. PER ADDITIONAL INFORMATION RECEIVED, END USER RECEIVED ANTIBIOTICS FOR ANOTHER UTI SHE WAS DIAGNOSED WITH DUE TO THE CLOUDY URINE OBSERVED. A SEPARATE EMDR HAS BEEN SUBMITTED FOR THE PREVIOUS UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 22342511 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES AFTER USE OF THE PRODUCT FOR 1 WEEK "SHE DEVELOPED A UTI AND THINKS IT WAS FROM THE T12 CATHETER." SHE HAD PAIN WITH INSERTION AND REMOVAL. SHE SAID SHE "TYPICALLY WASHES HER HANDS 2 X, CLEANSES HER MEATUS WITH AS SENSITIVE SKIN WIPE PRIOR TO CATHING AND USES A LARGE MIRROR TO GET THE CATHETER IN URETHRA, SHE SAID THE CATHETER ALWAYS GOES IN DIRECTLY INTO URETHRA AND SHE IS CAREFUL TO NOT CONTAMINATE IT IN ANY WAY PRIOR. SHE THEN DRAIN URINE BUT IT IS PAINFUL WHILE THE CATHETER GOES IN TO HER URETHRA AND THEN WHEN SHE REMOVES IT BUT PAIN GOES AWAY WHEN SHE REMOVES IT. LAST WEEK THOUGH SHE SAID HER URINE STARTED TO SMELL VERY BAD AND THEN SHE STARTED TO HAVE BURNING THAT KEPT GETTING WORSE. SHE SAID IT EVEN HURT AT NIGHT. SHE WENT TO CVS TO GET SOME CREAM AND PILLS TO TRY AND HELP HER URETHRAL PAIN (NAMES UNKNOWN) AND SHE SAID BY SUNDAY IT STARTED BURNING SO BAD AS WELL AS ITCHING AND SHE EVEN NOTED WHITE DISCHARGE WITH CATHING SO SHE WENT INTO THE ER AND THEY DID URINE TESTING AND SHE WAS DIAGNOSED WITH A UTI. SHE STOPPED CATHING AND TOOK ANTIBIOTICS (NAME UNKNOWN) PRESCRIBED FROM ER WHICH SHE SAID "REALLY HELPED" HER SYMPTOMS. SHE IS UNSURE IF POSSIBLY SENSITIVE TO

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 21113301 ↗
• InjuryOct 9, 2024Adverse 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 20407762 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS EXPERIENCING "MULTIPLE "BACK TO BACK" DIAGNOSED UTIS WHILE USING THIS PRODUCT." END USER STATES "SHE USED TO CATH REGULARLY IN 2022 FOR URINARY RETENTION. PRIOR TO THIS SHE SAID SHE HAD A FOLEY PLACED. SHE DOES NOT KNOW THE CAUSE OF HER RETENTION BUT WAS DIRECTED TO STOP CATHING AFTER HAVING RECURRENT UTIS WHEN SHE WOULD CATH REGULARLY. THE TIME SHE CATHED REGULARLY WAS IN 2022 FOR A FEW MONTHS SHE THINKS FROM (B)(6) 2022. SHE CALLED TODAY TO ASK IF ANYTHING ABOUT THE T14 CATHETER COULD CONTRIBUTE TO HER PAST UTIS, UNSURE OF HER CAUSE OF SO MANY UTIS WHEN SHE WOULD CATH. VERY DIFFICULT FOR HER TO REMEMBER DETAILS AND DOES NOT KNOW EXACT QTY OF DIAGNOSED UTIS ONLY STATES THEY WERE "BACK TO BACK EACH MONTH SHE CATHED" AS IT WAS SO LONG AGO. SHE SAID AS SOON AS SHE WOULD STOP TAKING THE VARIOUS ANTIBIOTIC TREATMENT COURSES (SHE SAID SHE TRIED A VARIETY OF THEM AS PRESCRIBED ONLY REMEMBERS THE NAME CIPRO - DENIES BEING ON ANY PROPHYLAXIS COURSE) THE SYMPTOMS OF FREQUENCY, URGENCY WOULD COME BACK AND ONCE SHE SAID EXPERIENCED FEVER AND CHILLS. SHE TAKES CRANBERRY PILLS FOR PREVENTION. SHE DOES NOT KNOW IF THE BACTERIA FOUND IN HER URINE EACH TIME SHE HAD A URINE TEST (U

  Patient problems: Urinary Tract Infection

  MAUDE report 20407660 ↗
• InjuryAug 8, 2024Device Handling Problem; Device Handling Problem

  END USER STATES "SHE HAS HAD 3 SURGERIES ON HER SPINE LAST IN AUGUST OF LAST YEAR AND NOW MAY NEED A 4RTH FUSION. SHE SAID THIS HAS AFFECTED HER BLADDERS ABILITY TO EMPTY AND SHE CAN RETAIN ABOUT 600ML. SHE WAS ADVISED TO BEGIN TO CATH 4 X A DAY BUT HAS BEEN DOING IT LESS SOMETIMES 3 - 2 X DUE TO THIS IRRITATION AND PAIN SHE HAS HAD WITH VARIOUS CATHETERS SHE HAS TRIALED. SHE SAID SHE HAS A HISTORY OF BEING ALLERGIC TO "PRESERVATIVES IN GENERAL" DOES NOT KNOW A SPECIFIC NAME BUT STATES SHE IS ALLERGIC TO ANESTHETIC PRESERVATIVES AND ANY PRESERVATIVES IN CHICKEN AS WELL AS THE PRESERVATIVES IN MIRCO-SUTURES. SHE WILL HAVE IRRITATION. SHE SAID SHE THINKS SHE IS HAD A REACTION TO ALL THE CATHETERS SHE HAS TRIED SO FAR DUE TO PRESERVATIVES IN THEM AND SPECIFICALLY THE LUBE IN THE CURE PRODUCTS. SHE HAD PRIMARILY USED T14 BUT AFTER USE SHE WILL HAVE IRRITATION AND PAIN IN HER URETHRA THAT CAN LAST DAYS. NO CONCERNS GETTING THESE IN. SHE SAID SHE WAS ADVISED BY HER MD OFFICE TO INITIALLY WASH AND REUSE THEM (DESPITE HER HAVING THIS IRRITATION) UNTIL HER ORDER ARRIVED AND SHE WAS DOING THAT WHEN SHE GOT A UTI. SHE WOULD CLEANSE THEM WITH HIBACLEANSE AND USE 1 CATHETER FOR THE WHOLE DAY PL

  Patient problems: Urinary Tract Infection

  MAUDE report 19938670 ↗
• InjuryAug 8, 2024Device Handling Problem; Device Handling Problem

  END USER STATES "SHE HAS HAD 3 SURGERIES ON HER SPINE LAST IN AUGUST OF LAST YEAR AND NOW MAY NEED A 4RTH FUSION. SHE SAID THIS HAS AFFECTED HER BLADDERS ABILITY TO EMPTY AND SHE CAN RETAIN ABOUT 600ML. SHE WAS ADVISED TO BEGIN TO CATH 4 X A DAY BUT HAS BEEN DOING IT LESS SOMETIMES 3 - 2 X DUE TO THIS IRRITATION AND PAIN SHE HAS HAD WITH VARIOUS CATHETERS SHE HAS TRIALED. SHE SAID SHE HAS A HISTORY OF BEING ALLERGIC TO "PRESERVATIVES IN GENERAL" DOES NOT KNOW A SPECIFIC NAME BUT STATES SHE IS ALLERGIC TO ANESTHETIC PRESERVATIVES AND ANY PRESERVATIVES IN CHICKEN AS WELL AS THE PRESERVATIVES IN MIRCO-SUTURES. SHE WILL HAVE IRRITATION. SHE SAID SHE THINKS SHE IS HAD A REACTION TO ALL THE CATHETERS SHE HAS TRIED SO FAR DUE TO PRESERVATIVES IN THEM AND SPECIFICALLY THE LUBE IN THE CURE PRODUCTS. SHE HAD PRIMARILY USED T14 BUT AFTER USE SHE WILL HAVE IRRITATION AND PAIN IN HER URETHRA THAT CAN LAST DAYS. NO CONCERNS GETTING THESE IN. SHE SAID SHE WAS ADVISED BY HER MD OFFICE TO INITIALLY WASH AND REUSE THEM (DESPITE HER HAVING THIS IRRITATION) UNTIL HER ORDER ARRIVED AND SHE WAS DOING THAT WHEN SHE GOT A UTI. SHE WOULD CLEANSE THEM WITH HIBACLEANSE AND USE 1 CATHETER FOR THE WHOLE DAY PL

  Patient problems: Urinary Tract Infection

  MAUDE report 19938627 ↗
• InjuryMay 4, 2023Device Handling Problem; Device Handling Problem

  END USER STATES "SHE FEELS LIKE HER LAST SHIPMENT OF CATHETERS (SHE GETS 600 PER 3 MONTHS) SHE HAS ¿OPENED A LOT OF THEM (BOXES)¿ HAS STILL HAS MULTIPLE BOXES AT HOME AND TRIED A FEW FROM EACH ALL OF SAME LOT #, AND THEY ALL SEEM TO LACK THE AMOUNT LUBRICATION SHE WAS USED TO WITH THIS CATHETER. SHE SAID THEY WERE NOT EXPOSED TO ANY HEAT IN HER HOME. SHE SAID THEY SEEM LIKE THEY ARE MORE ¿LIKE LITTLE DRIED BUMPS¿ OF LUBRICATION. SHE SAID THE GEL IS NOT ENOUGH AS THEY USED TO BE. SHE HAS USED THIS CATHETER BEFORE AND THIS WAS HER USUAL CATHETER. SHE SAID THEN BOUGHT KY JELLY TO ADD TO THEM SINCE THESE SEEMED DRIER TO BE ABLE TO USE THEM. SHE SAID SHE ¿RUNS THEM UNDER WATER¿ AND THEN LUBRICATES IT WITH THE KY JELLY WITH HER FINGER. SHE SAID BEFORE SHE APPLIES THE KY JELLY TO HER FINGERS TO PLACE ON THE CATHETER, SHE MAKES SURE TO WASH HER HANDS AND USE A CASTILLE SOAP WIPE ON HER FINGERS TOO." END USER WAS ADVISED HER TO STOP DOING THIS AND EXPLAINED THIS CONTAMINATES THE CATHETER AND CAN PLACE HER AT RISK FOR UTIS AS WELL. END USER STATES "SHE ALWAYS CLEANSES HER URETHRA WITH A CASTILLE SOAP WIPE AS WELL PRIOR TO INSERTION. SHE SAID SHORTLY AFTER USING THIS NEW BATCH OF CATHETER AND

  Patient problems: Urinary Tract Infection

  MAUDE report 16867287 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE'S GETTING FREQUENT UTIS AND SHE'S NOT SURE WHETHER IT'S THE PROCESS OR MAYBE THE CATHETER ITSELF." SHE SAID SHE "DOES VISIT THE DOCTOR DUE TO THE UTIS AND IS GETTING MEDICATION PRESCRIBED." NO FURTHER INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 16688665 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER RECENT CONTINUED USE OF THE CATHETER END USER DEVELOPED A UTI. DAUGHTER SAID HER MOM HAS BEEN CATHING HERSELF FOR 13 YEARS, 6 X DAY FOR RETENTION FROM BLADDER MUSCLE DYSFUNCTION AND IS 92 YEARS OLD. SHE SAID SHE HAD SOME TROUBLE WITH A BATCH OF HER USUAL COMPACT CATHETERS FROM A DIFFERENT SUPPLIER, HOWEVER LAST MONTH BEING HARD TO OPEN SHE WAS SENT SAMPLES OF DIFFERENT CATHETERS AND SHE LIKED THE T14 BY CURE. "THEY ORDERED A FULL MONTHS ORDER AND AFTER SOME CONTINUED USE OF 3 MU BOXES THEY CAUSED HER BURNING AND THEN SHE WAS DIAGNOSED WITH A UTI WHEN SHE WENT INTO THE HOSPITAL FOR CHF AND PNEUMONIA IN EARLY (B)(6) 2023 AND WAS ADMITTED FOR 3-4 DAYS. WHEN SHE WENT IN, SHE TOLD THE DOCTORS THERE THAT SHE ALSO FELT BURNING IN BLADDER/URETHRA AND THEY DID URINE TESTING AND FOUND OUT SHE INDEED DID HAVE A UTI. BURNING WAS HER ONLY UTI SYMPTOM. SHE WAS TREATED WITH ANTIBIOTIC DOXYCYCLINE FOR HER UTI AND IS FEELING MUCH BETTER NOW. DAUGHTER SAID THE ONLY THING THEY HAD CHANGED RECENTLY WAS THE CATHETER SHE HAD BEEN USING PRIOR TO GETTING THIS BURNING AND UTI AND THEY THINK IT WAS THE T14 THAT CAUSED HER UTI. SHE RARELY IF EVER GETS UTIS WITH OTHER CATHETERS BEFORE SW

  Patient problems: Urinary Tract Infection

  MAUDE report 16452153 ↗
• InjuryFeb 22, 2023Material Too Rigid or Stiff; Device Handling Problem; Material Too Rigid or Stiff; Device Handling Problem

  IT WAS REPORTED THE END USER PERFORMS "INTERMITTENT URINARY SELF-CATHETERIZATION X 12 YEARS. CATHETERIZES 8-15XDAY." END USER STATES "THE T10 CATHETER MATERIAL AND LUBRICANT ARE "ROUGH" AND IRRITATED HER URETHRA AND SHE WAS SUBSEQUENTLY HOSPITALIZED (B)(6) 2023 FOR A UTI (DIAGNOSED BY URINARY CULTURE) WHICH SHE ATTRIBUTES TO THE ROUGHNESS OF THE T10. SYMPTOMS INCLUDE FLANK PAIN AND AN EXACERBATION OF HER EXISTING DEPRESSION AND PANIC DISORDER (FEELING OF IMPENDING DEATH) AND SELF-DIAGNOSED PTSD. SHE WAS TRANSFERRED TO A PSYCH UNIT FOR 21 DAYS WHERE SHE RECEIVED KEFLEX ANTIBIOTIC. SHE WAS TOLD THE TRANSFER TO THE PSYCH UNIT WAS DUE TO A BAD REACTION TO MEDS (CAPLYTA) BUT SHE THINKS IT WAS JUST HER RESPONSE TO THE UTI." END USER IS HOME AT THIS TIME AND STATES SHE "CONTINUES TO USE THE T10 AND ALSO THE ULTRA10 WHICH SHE STATES FEELS ROUGH AS WELL. SHE IS CATHETERIZING 15XDAY DUE TO FREQUENCY. SHE DID NOT HAVE ANY BLADDER SCANS TO SEE IF HER BLADDER IS EMPTYING COMPLETELY BUT SHE DOES NOT FEEL THAT SHE IS. SHE IS REUSING HER CATHETERS AND "STERILIZES" THEM WITH BOILING WATER AND SOAP." END USER WAS INSTRUCTED NOT TO USE THE T10 OR ULTRA10 AND NOT TO REUSE /STERILIZE HER CATHETERS AS T

  Patient problems: Urinary Tract Infection

  MAUDE report 16418424 ↗

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