CURE ULTRA CATHETER ULTRA14Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00815947020444), received between Mar 29, 2018 and Sep 9, 2026 — classified as 51 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (50 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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported "patient is keeping UTI's for a long while now and has to stay on antibiotics all the time". No lot number provided.

  Patient problems: Urinary Tract Infection

  MAUDE report 50693528 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Urinary Tract Infection

  MAUDE report 24027312 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER IS A 70 YR OLD FEMALE WITH MS. SHE REPORTS SHE HAS BEEN CATHING 2 X A DAY FOR RETENTION FOR 2 YRS NOW. SHE STATES SHE HAS ALWAYS USED THE ULTRA14 AND IT HAS WORKED WELL FOR HER WHEN SHE IS ABLE TO GET IT IN HER URETHRA. SHE IS NOT BLAMING THE CATHETER FOR HER UTIS. SHE HAS DIFFICULTY AT TIMES FOR HER ENTIRE 2 YRS FINDING HER URETHRA. THIS OCCURS OFF AND ON. SHE HAS A SMALL MIRROR BUT OFTEN WILL TRY TO INSERT THE CATHETER 2 - 3 TIMES BEFORE FINDING THE CORRECT URETHRAL OPENING. ONCE IN, IT WILL DRAIN WELL AND SHE HAS NO COMPLAINTS WITH THE PRODUCT ITSELF, IT IS FINDING THE CORRECT SPOT TO PLACE IT IN. SHE ALSO IS GOOD ABOUT ALWAYS CLEANSING HER GENITAL AREA WITH A FRAGRANCE FREE COTTONELLE BRAND WIPE FOR CLEANSING PRIOR TO INSERTION. SHE REPORTS MOST RECENTLY SHE HAD A DIAGNOSED UTI ABOUT 4 WEEKS AGO. SHE WAS PREVIOUSLY ON LOW DOSE NITROFURANTOIN PRESCRIBED BY HER UROLOGIST FOR PROPHYLAXIS UTI PREVENTION SHE ESTIMATES FOR ABOUT 6 MONTHS PRIOR TO THE START OF THIS THIS PAST UTI. SHE SAID IT MUST HAVE STOPPED WORKING FOR HER AS SHE BECAME SYMPTOMATIC OF A UTI WITH URGENCY, FREQUENCY, MALODOROUS URINE AND DARK BROWN COLORED URINE OUTPUT. HER UROLOGIST HAD HER DO A URINE SPECIM

  Patient problems: Urinary Tract Infection

  MAUDE report 23388175 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20956506 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953507 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953505 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953504 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953269 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953267 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953077 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952989 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952987 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952854 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952838 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952836 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952498 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952494 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952392 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952223 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952169 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952168 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952166 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952164 ↗
• MalfunctionDec 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952163 ↗
• MalfunctionDec 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20948363 ↗