CURE ULTRA MALE CATHETER ULTRA M16CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00815947021120), received between Sep 7, 2018 and Jul 13, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Difficult to Remove

  Patient problems: Discomfort

  MAUDE report 25795418 ↗
• MalfunctionJul 1, 2025Sharp Edges; Sharp Edges

  END USER REPORTS HE "RECEIVED SOME DEFECTIVE PRODUCT WHERE THERE WAS DAMAGE TO THE EYELETS." NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE PHOTOS PROVIDED.

  Patient problems: Pain

  MAUDE report 22368235 ↗
• InjuryMar 18, 2024Device Handling Problem; Device Handling Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18923526 ↗
• InjuryMar 18, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED, A 'CONSUMER HAD A UTI SHORTLY AFTER USE' OF THIS CATHETER. CONSUMER SAID THERE WAS NOTHING WRONG WITH THE ULTRAM16C CATHETER IT WAS NOT DEFECTIVE IT WAS JUST HIM AS HE INSERTED IT WITHOUT MUCH PRACTICE THE FIRST FEW TIMES THAT CAUSED HIS UTI. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18921231 ↗
• MalfunctionJun 19, 2023Sharp Edges; Sharp Edges

  CASE DETERMINED TO NOT BE REPORTABLE BASED ON NEW INFORMATION RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17156343 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS "THE ULTRAM 16C CATHETERS ARE ALWAYS DIFFICULT TO INSERT AND CAUSED HIM SORENESS, PAIN, AND MOST RECENTLY EXPERIENCED BLEEDING WITH THEM AND BECAUSE OF THIS STATES BECAUSE OF THIS THEY WERE THE CAUSE OF HIS UTIS." CONSUMER STATES THIS CATHETERS WERE DIFFICULT FOR HIM TO INSERT INTO THE ENTIRE LENGTH OF HIS URETHRA AND HE FELT PARTICULAR "PINCHING" WHEN HE GOT INTO HIS BLADDER SPHINCTERS. HE SAID EVERY TIME HE WENT TO USE THEM HE NEVER LOOKED FORWARD TO IT BECAUSE IT WAS ALWAYS A UNCOMFORTABLE EXPERIENCES AND HE ALWAYS FELT SORENESS AFTER CATHING THAT VARIED IN HOW LONG IT WOULD LAST, HE DESCRIBED IT AS "PROGRESSIVE PAIN" FOR THE FEW WEEKS HE USED THEM MOST RECENTLY. HE NOTED THAT FINALLY HE HAD " A LOT" OF BLOOD COME OUT FOR ABOUT 3 DAYS STRAIGHT EVERY TIME AFTER HE CATH'D WITH THESE. HE SAID HE WOULD NOTE A "PORTION OF A BLOOD COAGULATION" ON THE TIP OF HIS CATHETER UPON REMOVAL AND HE ALSO NOTED THE URINE WAS MIXED WITH BLOOD AND IT WAS DARK COLORED. HE SAID THE BLEEDING STOPPED IMMEDIATELY AFTER CATHING EACH TIME. HE DOES TAKE A ASPIRIN 81MG NIGHTLY. BECAUSE OF THIS BLEEDING FOR 3 DAYS AFTER EACH CATH AND THE PAIN HE FELT INCREASED IN HIS URETHRA STATING IT WAS

  Patient problems: Urinary Tract Infection

  MAUDE report 14187251 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS "THE ULTRAM16C CATHETERS ARE ALWAYS DIFFICULT TO INSERT AND CAUSED HIM SORENESS, PAIN, AND MOST RECENTLY EXPERIENCED BLEEDING WITH THEM AND BECAUSE OF THIS STATES BECAUSE OF THIS THEY WERE THE CAUSE OF HIS UTIS". CONSUMER STATES THIS CATHETERS WERE DIFFICULT FOR HIM TO INSERT INTO THE ENTIRE LENGTH OF HIS URETHRA AND HE FELT PARTICULAR "PINCHING" WHEN HE GOT INTO HIS BLADDER SPHINCTERS. HE SAID EVERY TIME HE WENT TO USE THEM HE NEVER LOOKED FORWARD TO IT BECAUSE IT WAS ALWAYS A UNCOMFORTABLE EXPERIENCES AND HE ALWAYS FELT SORENESS AFTER CATHING THAT VARIED IN HOW LONG IT WOULD LAST, HE DESCRIBED IT AS "PROGRESSIVE PAIN" FOR THE FEW WEEKS HE USED THEM MOST RECENTLY. HE NOTED THAT FINALLY HE HAD " A LOT" OF BLOOD COME OUT FOR ABOUT 3 DAYS STRAIGHT EVERY TIME AFTER HE CATH'D WITH THESE. HE SAID HE WOULD NOTE A "PORTION OF A BLOOD COAGULATION" ON THE TIP OF HIS CATHETER UPON REMOVAL AND HE ALSO NOTED THE URINE WAS MIXED WITH BLOOD AND IT WAS DARK COLORED. HE SAID THE BLEEDING STOPPED IMMEDIATELY AFTER CATHING EACH TIME. HE DOES TAKE A ASPIRIN 81MG NIGHTLY. BECAUSE OF THIS BLEEDING FOR 3 DAYS AFTER EACH CATH AND THE PAIN HE FELT INCREASED IN HIS URETHRA STATING IT WAS "

  Patient problems: Urinary Tract Infection

  MAUDE report 14187250 ↗
• InjuryAug 21, 2020Difficult to Insert; Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  INTERMITTENT CATHETER PATIENT (USER) SAID THERE WAS NOT ENOUGH LUBRICANT ON ULTRAM16C CATHETERS AND THEY ALSO GAVE HIM A URINARY TRACT INFECTION (UTI). DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT THE INFECTION WAS NOT RESOLVED SO HE HAD TO TAKE ANOTHER COURSE OF ANTIBIOTICS THAT HE WAS STILL TAKING.

  Patient problems: Urinary Tract Infection

  MAUDE report 10439868 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (USER) REPORTED HE CONTRACTED A URINARY TRACT INFECTION. SYMPTOMS CONTINUED TO REOCCUR PERIODICALLY DESPITE SEVERAL ANTIBIOTIC TREATMENTS. DURING HIS MOST RECENT UROLOGY VISIT HIS DOCTOR ADVISED MORE FREQUENT CATHETERIZATION AND TO EXPECT A URINARY TRACT INFECTION TO OCCUR FROM TIME TO TIME AS A RESULT OF CATHETERIZATION IN GENERAL.

  Patient problems: Urinary Tract Infection

  MAUDE report 9679414 ↗
• InjurySep 7, 2018Device Difficult to Setup or Prepare; Microbial Contamination of Device; Device Difficult to Setup or Prepare; Microbial Contamination of Device

  PATIENT (USER) REPORTED HE CONTRACTED A URINARY TRACT INFECTION (UTI). HE REPORTED HE THINKS HE GOT A UTI DUE TO THE DEVICE PACKAGING BEING DIFFICULT FOR HIM TO OPEN. IT ONLY TORE HALF WAY ACROSS THE TOP SO HE HAD DIFFICULTY GETTING THE CATHETER OUT. AS A RESULT, HE THINKS HE HAD TO TOUCH THE CATHETER MORE THAN USUAL, THEREBY POSSIBLY CONTAMINATING THE CATHETER IN THE PROCESS. HIS DOCTOR PRESCRIBED NITROFURANTOIN (100MG, 3 X DAY) FOR 10 DAYS. HE TOOK THE MEDICATION AND RECOVERED COMPLETELY.

  Patient problems: Urinary Tract Infection

  MAUDE report 7858171 ↗