CURE ULTRA MALE CATHETER ULTRA M12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947021052), received between Nov 18, 2022 and Nov 18, 2022 — classified as 1 malfunction.

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

• MalfunctionNov 18, 2022Sharp Edges; Sharp Edges

  CONSUMER REPORTS BLEEDING DUE TO WHAT HE THINKS WAS A SHARP EDGE NEAR TIP, WITH USE OF ULTRAM12 CATHETERS. CONSUMER STATES HE HAD AN BLEEDING EPISODE THAT WAS THE "MOST BLOOD HE HAD EVER SEEN IN HIS PAST 32 YEARS" OF CATHETERIZATION WHEN HE REMOVED A CATHETER FROM HIS URETHRA A FEW WEEKS AGO. HE HAS USED THESE ULTRAM12S FOR YEARS AS HE HAS CATH'D FOR 32 YEARS NOW AND CURRENTLY CATHS 8-10 X A DAY FOR RETENTION FROM A AUTO ACCIDENT SPINAL CORD INJURY IN 1974. HE THINKS THE AREA THE BLEEDING WITH COMING FROM WAS AT THE ENTRANCE TO HIS BLADDER AND WHEN HE PULLED CATHETER OUT HE FELT IT "DRAG ON SOMETHING" IN THAT AREA. NO PAIN OR DIFFICULTY GETTING IT IN AT ALL. HE THINKS "IT MUST HAVE BEEN A ROUGH AREA ON THE CATHETER ITSELF" TO HAVE CAUSED THIS. HE THINKS HE HAS A LOT OF SCAR TISSUE THAT COULD ALSO BE TO BLAME. HE SAID HE HAS BEEN "REAMED OUT TWICE" OF SCAR TISSUE BUILD UP IN HIS URETHA LAST BEING MULTIPLE YEARS AGO. HE SAID HE HAD SUBSEQUENT BURNING FOLLOWING THAT CATH AND MORE BLEEDING IN LESSER AMOUNTS THAT OCCURRED A FEW MORE TIMES WITH THE SUBSEQUENT 3 OR 4 CATHS AFTER THAT ONE AS HE BELIEVES A SCAB FORMED INSIDE AND WOULD GET KNOCKED OUT WITH THOSE SUBSEQUENT CATHS. BLEEDING DI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15828323 ↗