CURE CATHETER M12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815947020024), received between Aug 19, 2019 and Oct 29, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072539); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: Pain

  MAUDE report 20558658 ↗
• InjuryApr 29, 2024Break; Break

  END USER REPORTS CATHETER BREAKING APART (WITH USE) IN HIS URETHRA. END USER REPORTS USING NEEDLE NOSE PLIERS TO PULL CATHETERS OUT OF HIS URETHRA. HE REPORTS THAT 5 TOTAL HAVE BROKEN OFF AND "I HAVE HAD TO MANIPULATE THE BROKEN PART UP THE URETHRA FAR ENOUGH TO GRAB THEM WITH NEEDLE NOSE PLIERS TO REMOVE THEM". END USER REPORTS THAT THERE WERE 5 CATHETERS THAT BROKE 3-4 " UP FROM THE EYELETS. HE SAYS ON INSPECTION HE NOTICED A WHITE MARK IN THE CATHETER LIKE IT HAD BEEN BENT AND THE PLASTIC WAS WEAKENED. HE IS USING A 12FR STRAIGHT CATHETER. HE REPORTS BLEEDING FOR 4 DAYS, IS ON ANTIBIOTICS AND IS DRIPPING BLOOD IN BETWEEN CATHETERIZATION AS WELL. HE CATHS 7-10 X PER DAY. HE HAS TERMINAL ASBESTOS CANCER THAT IS IN HIS KIDNEYS, BLADDER LUNGS ETC. ADDITIONALLY, END USER REPORTS BLEEDING FROM HIS URETHRA PRIOR TO THIS TRAUMATIC EVENT DUE TO HIS TERMINAL DIAGNOSIS BUT THIS EVENT DID CAUSE TRAUMA AND MORE BLEEDING.

  Patient problems: Unspecified Infection

  MAUDE report 19201337 ↗
• InjuryJan 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  CONSUMER REPORTS THAT HE DEVELOPED A URINARY TRACT INFECTION WHILE USING THE CATHETERS IN (B)(6) 2021. HE STATES THAT HE HAS BEEN CATHETERIZING FOR THE PAST 12 YEARS 3 TIMES PER DAY THROUGH HIS PENIS INTO HIS NEOBLADDER FOR URINARY RETENTION. HE REPORTS THAT HE WASHES HIS HANDS WITH SOAP AND WATER PRIOR TO CATHETERIZING. HE THEN WASHES HIS PENIS USING A SANITIZING WIPE. HE USES A TUBE OF LUBRICATING GEL APPLIED TO CATHETER AND RECAPPED. HE HOLDS THE CATHETER AND INSERTS THE CATHETER BUT REPORTS HE HAS TO TOUCH THE ENTIRE CATHETERS AS HE ADVANCES THE CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 13394568 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) REPORTED EXPERIENCING A RECURRENT URINARY TRACT INFECTION (UTI). HE WAS PRESCRIBED THREE ROUNDS OF ANTIBIOTICS WHICH AT THE TIME OF THE LAST COMMUNICATION HAD BEEN UNSUCCESSFUL AT TOTALLY CLEARING THE INFECTION. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9781577 ↗
• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (USER) REPORTED HE SUFFERED A URINARY TRACT INFECTION (UTI) AND WAS PRESCRIBED AN ANTIBIOTIC FOR 10 DAYS. HE FINISHED THE COURSE OF ANTIBIOTICS, BUT THE INFECTION DID NOT GO AWAY. HE EXPLAINED HE HAD TO GO INTO THE HOSPITAL ON (B)(6) 2019 DUE TO PAIN. HE SAID HE WAS TOLD HE HAD A KIDNEY STONE AND UTI SO WAS PUT ON A FOLEY AND PRESCRIBED AN ANTIBIOTIC. THE ORIGINAL INFECTION HAD NOT GONE AWAY.

  Patient problems: Urinary Tract Infection

  MAUDE report 8908428 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072539. One submission often covers many models, so check the product and lot details in each record.

• Z-0004-2013 · Sep 19, 2012 · Terminated
  Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (