CURE CATHETER M12CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815947020079), received between Mar 17, 2022 and Aug 6, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER STATES "WHITE PAPER PARTICLES/ DUST IN BOXES AND GETS ON CATHETERS IF HE OPENS THEM." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728480 ↗
• MalfunctionAug 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER STATES "WHITE PAPER PARTICLES/ DUST IN BOXES AND GETS ON CATHETERS IF HE OPENS THEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728479 ↗
• MalfunctionJan 8, 2025Tear, 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: Discomfort

  MAUDE report 21102991 ↗
• MalfunctionJan 8, 2025Tear, 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: Discomfort

  MAUDE report 21102989 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER "STATES HE USED QTY 75 CATHETERS CURE M12C FROM UNKNOWN MARKET UNITS THAT WERE DIFFICULT FOR HIM TO USE WHEN INSERTING IN HIS URETHRA, DID NOT GLIDE IN WELL FELT LIKE HE WAS MEETING RESISTANCE WITH EVERY USE, LEADING HIM TO HAVE A UTI." HE ATTEMPTED TO USE M12C FOR ABOUT THE LAST FEW WEEKS AS HE CATHS 4-5 X A DAY AND NOTED DIFFICULTY PASSING IN HIS URETHRA AND OFTEN HE HAD TO TOUCH THE CATHETER "FORCING IT TO GO IN" TO DRAIN HIS BLADDER. HE USES LUBRICATION PRIOR TO INSERTION, FAMILIAR WITH PROPER COUDE PLACEMENT. HE DOES CLEANSE HIS MEATAL OPENING WITH A ANTIBACTERIAL WIPE PRIOR TO INSERTION. HE DOES NOT ALWAYS WASH HIS HANDS PRIOR TO USE. HE IS PARALYZED FROM THE WAIST DOWN AND HAS NO FEELING WHEN CATHING. YESTERDAY HE WAS NOT FEELING WELL, OVERALL RUNDOWN AND SAID HE HAD COLD LIKE SYMPTOMS AND FEVER. HE OFTEN FEELS THIS WAY WHEN HE HAS A UTI. HE WENT INTO HIS ER AND THEY RAN A UA WHICH WAS POSITIVE FOR POSSIBLE INFECTION AND HE SAID THE URINE CULTURE IS STILL IN PROCESS. HE WAS PRESCRIBED LEVAQUIN ANTIBIOTIC AND HE HAS YET TO PICK IT UP. END USER WAS ADVISED HIM TO NOT USE THESE CATHETERS AND WAS REMINDED OF HAND HYGIENE PRIOR TO USE AND PROPER CLEAN INTERMITTENT CATHET

  Patient problems: Urinary Tract Infection

  MAUDE report 13802690 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER "STATES HE USED QTY 75 CATHETERS CURE M12C FROM UNKNOWN MARKET UNITS THAT WERE DIFFICULT FOR HIM TO USE WHEN INSERTING IN HIS URETHRA, DID NOT GLIDE IN WELL FELT LIKE HE WAS MEETING RESISTANCE WITH EVERY USE, LEADING HIM TO HAVE A UTI." HE ATTEMPTED TO USE M12C FOR ABOUT THE LAST FEW WEEKS AS HE CATHS 4-5 X A DAY AND NOTED DIFFICULTY PASSING IN HIS URETHRA AND OFTEN HE HAD TO TOUCH THE CATHETER "FORCING IT TO GO IN" TO DRAIN HIS BLADDER. HE USES LUBRICATION PRIOR TO INSERTION, FAMILIAR WITH PROPER COUDE PLACEMENT. HE DOES CLEANSE HIS MEATAL OPENING WITH A ANTIBACTERIAL WIPE PRIOR TO INSERTION. HE DOES NOT ALWAYS WASH HIS HANDS PRIOR TO USE. HE IS PARALYZED FROM THE WAIST DOWN AND HAS NO FEELING WHEN CATHING. YESTERDAY HE WAS NOT FEELING WELL, OVERALL RUNDOWN AND SAID HE HAD COLD LIKE SYMPTOMS AND FEVER. HE OFTEN FEELS THIS WAY WHEN HE HAS A UTI. HE WENT INTO HIS ER AND THEY RAN A UA WHICH WAS POSITIVE FOR POSSIBLE INFECTION AND HE SAID THE URINE CULTURE IS STILL IN PROCESS. HE WAS PRESCRIBED LEVAQUIN ANTIBIOTIC AND HE HAS YET TO PICK IT UP. END USER WAS ADVISED HIM TO NOT USE THESE CATHETERS AND WAS REMINDED OF HAND HYGIENE PRIOR TO USE AND PROPER CLEAN INTERMITTENT CATHET

  Patient problems: Urinary Tract Infection

  MAUDE report 13802688 ↗

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 (