CURE TWIST T16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947020406), received between May 4, 2023 and May 4, 2023 — classified as 1 injury.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗