CURE ULTRA MALE CATHETER ULTRA M10CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815947021090), received between May 20, 2022 and May 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Sharp Edges” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES "THE CATHETERS BLUE LINE WAS NOT PRINTED STRAIGHT DOWN DELINEATING THE COUDE TIP BUT RATHER IT WAS TWISTED "LIKE A CANDY CANE" AS WELL AS SOME HAD A SHARPNESS TOWARDS THE END, BY THE EYELETS WHICH CASED HIM TEARING IN HIS URETHRA, BLEEDING AND RESULTED IN A UTI. HE CATHS 3 X A DAY FOR RETENTION DUE TO AN ENLARGED PROSTATE AND HISTORY OF PROSTATE CANCER. HE WASN'T SURE IF SOME OF THE CATHETERS THAT HAD THE BLUE LINE THAT WAS PRINTED TWISTED AND NOT FOLLOWING THE COUDE TIP WERE ALSO AFFECTED WITH THE SHARPNESS HE FELT AT THE TIP AT THE ROUGH EYELETS, HE SAID THEY VERY WELL COULD HAVE. WHEN HE PLACED THE CATHETER WITH THE WAVY BLUE LINES HE NOTED IT WAS UNCOMFORTABLE GOING IN AS THE TIP TWISTED INTERNALLY. AFTER HE NOTICED THE BLUE LINE WAS NOT PRINTED STRAIGHT, HE SAID HE WOULD MAKE SURE TO HOLD IT AT THE FUNNEL END WITH THE COUDE TIP UP AND NOT FOLLOW THE LINE. HE SAID HE IS AWARE TO PLACE COUDE TIP POINTED UPWARDS. HE HAS CATH'D FOR 7 YEARS. HE IS ALWAYS MAKES SURE TO WASH HIS HANDS PRIOR TO CATHING OR SANITIZE HIS HANDS IF WATER IS NOT AVAILABLE AND HE ALWAYS WIPES HIS MEATUS PRIOR TO PLACING HIS CATHETERS. HE ALSO IS MINDFUL TO KEEP HIS CATHETER STERILE AND NOT TO

  Patient problems: Skin Tears; Urinary Tract Infection

  MAUDE report 14461232 ↗
• InjuryMay 20, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES "THE CATHETERS BLUE LINE WAS NOT PRINTED STRAIGHT DOWN DELINEATING THE COUDE TIP BUT RATHER IT WAS TWISTED "LIKE A CANDY CANE" AS WELL AS SOME HAD A SHARPNESS TOWARDS THE END, BY THE EYELETS WHICH CASED HIM TEARING IN HIS URETHRA, BLEEDING AND RESULTED IN A UTI. HE CATHS 3 X A DAY FOR RETENTION DUE TO AN ENLARGED PROSTATE AND HISTORY OF PROSTATE CANCER. HE WASN'T SURE IF SOME OF THE CATHETERS THAT HAD THE BLUE LINE THAT WAS PRINTED TWISTED AND NOT FOLLOWING THE COUDE TIP WERE ALSO AFFECTED WITH THE SHARPNESS HE FELT AT THE TIP AT THE THE ROUGH EYELETS, HE SAID THEY VERY WELL COULD HAVE. WHEN HE PLACED THE CATHETER WITH THE WAVY BLUE LINES HE NOTED IT WAS UNCOMFORTABLE GOING IN AS THE TIP TWISTED INTERNALLY. AFTER HE NOTICED THE BLUE LINE WAS NOT PRINTED STRAIGHT, HE SAID HE WOULD MAKE SURE TO HOLD IT AT THE FUNNEL END WITH THE COUDE TIP UP AND NOT FOLLOW THE LINE. HE SAID HE IS AWARE TO PLACE COUDE TIP POINTED UPWARDS. HE HAS CATH'D FOR 7 YEARS. HE IS ALWAYS MAKES SURE TO WASH HIS HANDS PRIOR TO CATHING OR SANITIZE HIS HANDS IF WATER IS NOT AVAILABLE AND HE ALWAYS WIPES HIS MEATUS PRIOR TO PLACING HIS CATHETERS. HE ALSO IS MINDFUL TO KEEP HIS CATHETER STERILE AND NO

  Patient problems: Skin Tears; Urinary Tract Infection

  MAUDE report 14461094 ↗