CURE CATHETER F16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815947020222), received between Sep 22, 2017 and Mar 29, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE HAS BEEN CATHING FOR 5 X A DAY FOR YEARS NOW FOR RETENTION FROM A CYST/ GROWTH FOUND ON OPENING OF BLADDER. SHE WAS USED TO USING THE MAGIC 3 GO CATHETER THAT ALWAYS WORKED WELL FOR HER BUT IS NOW ON BACKORDER. SHE SAID A FEW WEEKS AGO WHEN SHE FIRST STARTED USING THIS CATHETER SHE WAS SENT BY HER SUPPLIER, SHE NOTED THEY WERE A "LITTLE BIT UNCOMFORTABLE" GOING IN AT FIRST AND THEN THE DISCOMFORT STOPPED WITH USE SHE SAID AND THEN SHORTLY AFTER THAT SHE GOT HER UTI SYMPTOMS. SHE SAID SHE HER UTI SYMPTOMS WERE ¿DISCOMFORT, A LITTLE BIT ITCHY AND BURNING.¿ SHE CALLED INTO HER PROVIDER AND THEY PRESCRIBED AN ORAL COURSE OF ANTIBIOTICS CIPROFLOXACIN OVER THE PHONE FOR HER. SHE DID NOT GO INTO LAB OR PROVIDE A URINE SAMPLE AS SHE SAID HER TOWN HAD A COVID OUTBREAK SO SHE DID NOT GO ANYWHERE NOR DID HER MD REQUIRE URINE TESTING FOR THE CIPROFLOXACIN. SHE SAID THAT ANTIBIOTIC WORKED RIGHT AWAY WHICH SHE WAS GRATEFUL FOR AS SHE SAID SHE HAS SULFA ALLERGIES AND PENICILLIN ALLERGIES. SHE SAID THIS WAS THE FIRST UTI SHE HAS EVER HAD IN HER LIFE." SHE FURTHER STATES SHE "WASHES HER HANDS WITH ANTIBACTERIAL SOAP PRIOR, DOES NOT TOUCH THE CATHETER TUBING THAT GOES INTO HER W

  Patient problems: Urinary Tract Infection

  MAUDE report 16639970 ↗
• MalfunctionSep 22, 2017Off-Label Use; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Off-Label Use; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component

  WHILE USING INTERMITTENT CATHETER OFF-LABEL AS AN INDWELLING CATHETER FOR STOMA USE, THE FUNNEL SEPARATED AND THE TUBING WAS TEMPORARILY RETAINED IN THE PATIENT'S STOMA. THE TUBING WAS REMOVED IN THE HOSPITAL. NO INJURY WAS REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 6888544 ↗

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 (