CURE CATHETER M18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815947020055), received between Aug 23, 2022 and May 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Sharp Edges; Sharp Edges

  END USER REPORTS "SHE HAS BEEN USING THIS PRODUCT SINCE HER INDIANA POUCH SURGERY IN (B)(6) 2020 AFTER SUFFERING WITH INTERSTITIAL CYSTITIS FOR 35 YRS. SHE CATHS HER STOMA EVERY 4 HR HOURS AROUND THE CLOCK AND FLUSHES HER NEOBLADDER 2-3 TIMES A DAY WITH STERILE WATER THROUGH A CATHETER TIP SYRINGE." SHE REPORTS "FINDING MANY CATHETERS WITH "ROUGH EYELETS" SHE ESTIMATES "ABOUT 1/4 OF CATHETERS" IN HER PAST 3 MONTH SHIPMENT NEARLY USED UP OF 600 CATHETERS, SHE FOUND TO HAVE "ROUGHNESS ON THE EYELETS." SHE SAID SHE ALWAYS LUBRICATES HER CATHETER AND THEN INSERTS IT CAREFULLY AND OFTEN HAS TO "MOVE IT IN AND OUT" THROUGH STOMA TO GET ALL RESIDUAL URINE OUT BUT SHE COULD FEEL THESE ROUGH EYELETS AS SHE DID THIS. UPON REMOVAL, DESPITE WEARING GLOVES, SHE COULD EVEN FEEL THESE ROUGH EYELETS THROUGH HER GLOVES AS SHE CHECKED THESE AFTER FEELING THAT. SHE SAID THE SORENESS WOULD LAST A DAY AND GO AWAY WITHOUT INTERVENTION. SHE ALSO ALWAYS KEEPS GAUZE COVERING HER STOMA AND WOULD ALSO NOTICED BLOOD SPOTTING ON THE GAUZE AS WELL AFTER USING THESE WITH CATHETERS THAT HAD ROUGH EYELETS. SHE SAID EVEN THE FOLLOWING TIME SHE WOULD CATH, SHE WOULD NOTICE SOME BLOOD IN HER RESIDUAL URINE THAT WOULD

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 22061732 ↗
• MalfunctionMay 21, 2025Sharp Edges; Sharp Edges

  END USER REPORTS "SHE HAS BEEN USING THIS PRODUCT SINCE HER INDIANA POUCH SURGERY IN (B)(6) 2020 AFTER SUFFERING WITH INTERSTITIAL CYSTITIS FOR 35 YRS. SHE CATHS HER STOMA EVERY 4 HR HOURS AROUND THE CLOCK AND FLUSHES HER NEOBLADDER 2-3 TIMES A DAY WITH STERILE WATER THROUGH A CATHETER TIP SYRINGE." SHE REPORTS "FINDING MANY CATHETERS WITH "ROUGH EYELETS" SHE ESTIMATES "ABOUT 1/4 OF CATHETERS" IN HER PAST 3 MONTH SHIPMENT NEARLY USED UP OF 600 CATHETERS, SHE FOUND TO HAVE "ROUGHNESS ON THE EYELETS." SHE SAID SHE ALWAYS LUBRICATES HER CATHETER AND THEN INSERTS IT CAREFULLY AND OFTEN HAS TO "MOVE IT IN AND OUT" THROUGH STOMA TO GET ALL RESIDUAL URINE OUT BUT SHE COULD FEEL THESE ROUGH EYELETS AS SHE DID THIS. UPON REMOVAL, DESPITE WEARING GLOVES, SHE COULD EVEN FEEL THESE ROUGH EYELETS THROUGH HER GLOVES AS SHE CHECKED THESE AFTER FEELING THAT. SHE SAID THE SORENESS WOULD LAST A DAY AND GO AWAY WITHOUT INTERVENTION. SHE ALSO ALWAYS KEEPS GAUZE COVERING HER STOMA AND WOULD ALSO NOTICED BLOOD SPOTTING ON THE GAUZE AS WELL AFTER USING THESE WITH CATHETERS THAT HAD ROUGH EYELETS. SHE SAID EVEN THE FOLLOWING TIME SHE WOULD CATH, SHE WOULD NOTICE SOME BLOOD IN HER RESIDUAL URINE THAT WOULD

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 22061731 ↗
• MalfunctionAug 23, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "URETHRAL IRRITATION AS THEY FELT SHARP WITH INSERTION WITH USE OF QTY "2 OR 3" M18 CATHETERS FROM 1 MU BOX BACK AT THE BEGINNING OF THIS YEAR IN "JANUARY OR MARCH", LOT UNKNOWN. HE STATES THAT THEY "FELT SHARP" ONLY GOING IN. THIS FEELING WAS FELT MORE PART WAY IN, NOT INITIALLY. HE SAID HE TRIED 2 OR 3 OTHERS TO MAKE SURE IT WASN'T JUST AN ISSUES WITH ONE AND HE SAID THEY ALL FELT THAT WAY. HE DID NOT SEE ANYTHING ABNORMAL OR SHARP ON THE CATHETER ITSELF. HE IMMEDIATELY DISCONTINUED USE. HE SAID THE IRRITATION DID NOT LAST TOO LONG, NO MEDICAL INTERVENTION SOUGHT. HE DID NOT GET AN INFECTION BUT FELT WORRIED HE MAY IF HE CONTINUED USING THEM. HE SAID HE DID APPLY LUBRICANT TO THEM PRIOR TO USE. HE SAID HE USES THE SAME ADDITIONAL LUBRICANT ON HIS REGULAR CATHETERS AS WELL EVEN THOUGH THEY ARE THE HYDROPHILIC BARD MAGIC 3S. HE SAID THESE HAVE NEVER CAUSED HIM IRRITATION OR PAIN GOING IN. HE CURRENTLY USES HIS BARD MAGIC 3'S." END USER WAS ADVISED "NOT USE THE M18S AND HE SAID HE HAS ALREADY DISCONTINUED USE." END USER STATES "HE CATHS 4 X A DAY FOR RETENTION FROM HIS DIAGNOSIS CEREBRAL PALSY RESULTING IN NEUROGENIC BLADDER. HE HAS BEEN CATHING SINCE 1994."

  Patient problems: Pain

  MAUDE report 15275770 ↗

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 (