CURE MEDICAL K1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815947020468), received between Mar 2, 2019 and Apr 22, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (3 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  INTERMITTENT CATHETER PATIENT (USER) SAID SHE GOT A URINARY TRACT INFECTION (UTI) AND HAS BEEN SICK FOR SIX MONTHS CONCURRENT WITH USE OF A CATHETER FROM ANOTHER MANUFACTURER BUT THINKS IT IS FROM USING GLOVES FROM A CURE MEDICAL BRAND CATHETER KIT (GLOVES, BZK WIPE, COLLECTION BAG, MATTRESS PROTECTOR, LUBRICATING JELLY). SHE NOTICES THE GLOVES HAVE HAD A BLACK SUBSTANCE ON OR IN THE GLOVES - MORE THAN DUST - LOOKS LIKE IT WAS WET, DRIED, AND THEN FLAKED OFF. THE BLACK SUBSTANCE IS EMBEDDED IN THE RIM OF THE GLOVE. THE PATIENT SAID THE BACTERIA IS RARE ACCORDING TO HER DOCTOR WHO CANNOT TELL WHERE IT IS COMING FROM BUT KNOWS IT IS CATHETER RELATED. DURING FOLLOW-UP, THE PATIENT SAID WAS PRESCRIBED A DOSE OF BACTRIM, THEN A SECOND AND THIRD DOSE, BUT THE INFECTION WAS NOT RESOLVED. SHE WAS THEN PLACED ON BACTRIM AS A MAINTENANCE ANTIBIOTIC THAT RESOLVED THE INFECTION AND FEELS FINE NOW.

  Patient problems: Urinary Tract Infection

  MAUDE report 11711064 ↗
• InjuryFeb 6, 2020Difficult to Insert; Difficult to Insert

  PATIENT (USER) REPORTED LUBRICANT WAS TOO STICKY AND DIFFICULT TO APPLY TO THE CATHETER WHICH MADE INSERTION DIFFICULT. HE FEELS THE POOR LUBRICANT CONTRIBUTED TO HIM ACQUIRING A URINARY TRACT INFECTION. HE WAS PRESCRIBED AN ANTIBIOTIC AND RECOVERED FULLY.

  Patient problems: Urinary Tract Infection

  MAUDE report 9678598 ↗
• InjuryMar 2, 2019Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  ROUTINE INTERMITTENT CATHETER PATIENT (USER) ACQUIRED A UTI WHILE CONCURRENTLY USING BOTH A CURE MEDICAL BRAND INTERMITTENT CATHETER AND CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD, LUBRICATING JELLY). NO SPECIFIC PROBLEMS WERE REPORTED WITH THE CATHETER OR INSERTION KIT BUT THE USER STATED HE HAD DIFFICULTY INSERTING THE CATHETER. THE USER ALSO REPORTED HE WAS NOT FOLLOWING THE RECOMMENDED TECHNIQUE WHICH MAY INTRODUCE CONTAMINATION THAT COULD CAUSE OR CONTRIBUTE TO AN INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 8384561 ↗
• InjuryMar 2, 2019Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  ROUTINE INTERMITTENT CATHETER PATIENT (USER) ACQUIRED A UTI WHILE CONCURRENTLY USING BOTH A CURE MEDICAL BRAND INTERMITTENT CATHETER AND CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD, LUBRICATING JELLY). NO SPECIFIC PROBLEMS WERE REPORTED WITH THE CATHETER OR INSERTION KIT BUT THE USER STATED HE HAD DIFFICULTY INSERTING THE CATHETER. THE USER ALSO REPORTED HE WAS NOT FOLLOWING THE RECOMMENDED TECHNIQUE WHICH MAY INTRODUCE CONTAMINATION THAT COULD CAUSE OR CONTRIBUTE TO AN INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 8384470 ↗