CURE TWIST T10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815947020376), received between Jul 19, 2022 and Jun 27, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "PAIN AND BURNING IN HER URETHRA AND RECTUM AFTER USE OF T10 CATHETERS FROM LUBRICANT THAT ALL "SMELLED LIKE ALCOHOL" FROM HER NEWEST SHIPMENT." ON (B)(6) 2022 CONSUMER HAD REPORTED BURNING AFTER USE OF THE ULTRA10 CATHETERS WHICH WAS CAPTURED IN A SEPARATE COMPLAINT CASE. SHE SAID SHE WAS THEN SENT A NEW SHIPMENT OF HER USUAL T10 CATHETERS AND SHE NOTED THAT THE CATHETERS LUBRICANT HAD THE SAME "ALCOHOL SMELL" AS THE ULTRA10S HAD PRIOR TO USE AND CAUSED HER BURNING AFTER CATHING, STATING IT FELT LIKE THE NEWER T10S "SET HER ON FIRE". SHE SAID SHE STILL NOW , A WEEK AND HALF LATER, HAS BURNING IN URETHRA. SHE HAS STOPPED CATHING AND THE BURNING IS STILL PRESENT TODAY, HOWEVER, LESS THAN LAST WEEK. SHE FEELS LIKE SHE IS LEAKING MORE URINE HAS MORE FREQUENCY TO VOID SMALL AMOUNTS OF URINE AS WELL, DENIES FEVERS. SHE HAS BEEN TRYING TO DRINK MORE WATER AND LESS SODA WHICH HAS BEEN HELPING. SHE SAID THE BURNING ALSO MIGRATED TO HER RECTUM AND CAUSING BURNING AND ITCHING AND "SHE CAN BARELY SIT DOWN." SHE THINKS SOMETHING HAS CHANGED IN THE LUBRICANT, NOTED BY THE ALCOHOL SMELL, THAT CAUSED HER TO HAVE THIS REACTION. SHE SAID NOTHING ON THE OUTSIDE PACKAGING OR WITH THE

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 15051176 ↗