CURE CATHETER M14URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815947020123), received between Mar 2, 2020 and Jun 9, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Contamination /Decontamination Problem

  To date no additional patient or event details have been received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445526 ↗
• MalfunctionMar 25, 2025Sharp Edges; Sharp Edges

  END USER REPORTS HE HAD A BOX OF CATHETERS THAT WERE VERY ROUGH AND NOT SMOOTH AROUND THE TIP. HE REPORTS HE HAS BEEN CATHING FOR A WHILE AND HAS USED THIS PRODUCT BEFORE. HE STATES HE OPENED THE FIRST BOX OF M14U AND NOTICED THE ROUGHNESS ON THE END OF THE CATHETER AFTER USE. HE THEN OPENED ANOTHER BOX (BELIEVES THE SAME LOT# ALTHOUGH UNKNOWN) AND THE CATHETERS WERE ROUGH. ALL THE BOXES BELIEVED TO HAVE HAD THE SAME LOT#, BUT NOT ALL THE CATHETERS WERE ROUGH. END USER STATES HE STARTED TO LICK/PUT HIS TONGUE ON THE END OF THE CATHETERS BEFORE USE TO INDICATE IF THEY WERE ROUGH. HE STATES THE ROUGHNESS COVERS THE END OF THE CATHETER BUT DOES NOT AFFECT THE EYELETS. END USER DENIES ANY HARM FROM PRODUCTS USED. HE STATES THERE WAS NO BLEEDING, BUT THE CATHETERS WERE IRRITATING. NO PHOTO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692707 ↗
• InjuryApr 8, 2020Material Too Rigid or Stiff; Sharp Edges; Material Too Rigid or Stiff; Sharp Edges

  INTERMITTENT CATHETER PATIENT (USER) REPORTED THAT M14U CATHETERS WERE CAUSING HIM TO BLEED AND HAVE URINARY TRACT INFECTIONS (UTI). DURING FOLLOW-UP, THE PATIENT REPORTED HE RECOVERED COMPLETELY AFTER TAKING THE FULL COURSE OF ANTIBIOTICS PRESCRIBED BY HIS DOCTOR.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 9941627 ↗
• InjuryMar 2, 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 (URI) FOR 6-8 WEEKS. DUE TO HIS HISTORY WITH RECURRENT UTI HIS DOCTOR PRESCRIBED CIPROFLOXACIN TO TAKE WHEN HE FELT SYMPTOMS COMING ON. PATIENT STATED THAT HE WOULD TAKE THE CIPROFLOXACIN FOR ABOUT A WEEK AND UTI SYMPTOMS WOULD GO AWAY BUT THEN REOCCUR SEVERAL TIMES BEFORE FINALLY CLEARING UP.

  Patient problems: Urinary Tract Infection

  MAUDE report 9775262 ↗

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 (