CURE CATHETER CLOSED SYSTEM CS14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815947020673), received between Mar 4, 2022 and Sep 16, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Handling Problem

  End user states "He said some would go in the first inch and will fold back, some others won't go in his urethra at all as they are too flexible. He has no stricture/scar tissue he is aware of. Others he could not pass his prostate and some fold at this point and others just won't pass as they lack the rigidity that he is used to with this product. He said at times it will be 5 in a row that won't go in and then he will try another one and have no problems at all. He said he will go weeks without this being an issue and then he will get another 3 in a row that will give him the same trouble. He said due to the trouble of not being able to pass a few he did experience bleeding. He does not bleed often but states he is prone to UTIs with bleeding events. The bleeding was slight and only was noted on ends of catheters and a little on a pad before stopping on its own. After he had malodorous urine and cloudy urine and went to see his infectious disease MD. They checked his urine and he was found to have a UTI and prescribed a week treatment dose of Bactrim which cleared up his symptoms. He said they checked his PSA and his prostate and nothing appeared too swollen. He has regular follo

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 50789141 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER, 56 YEAR OLD PARAPLEGIC, REPORTS "ABOUT 6-7 MONTHS HE HAD HIS INITIAL EXPERIENCE WITH DEFECTED DRIED UP/ THICK LUBRICANT IN A CASE OF THE CS14 CATHETERS." HE DID NOT REPORT THE ISSUE AT THAT TIME BUT HAS RECEIVED ANOTHER CASE WITH SAME DEFECT IN A RECENT ORDER. WHEN HE FIRST STARTING EXPERIENCING THE DEFECTED DRIED LUBRICANT THOSE 6-7 MONTHS AGO FROM THAT CASE HE DIDN'T KNOW WHAT WAS WRONG AT FIRST. HE THOUGHT MAYBE HE WAS JUST DEHYDRATED. HE SAID HE FELT A LOT OF "DRAG" IN URETHRA WITH INSERTION AND RETRACTION FROM CATHETERS IN THIS CASE WHICH CAUSED IRRITATION/ URETHRITIS. HE SAID HIS SYMPTOMS OF URETHRITIS KEPT GETTING WORSE WITH EACH CATH SO HE WENT TO THE MD AND THEY DID A URINE SAMPLE AND HE SAID "IT WASN'T A FULL BLOWN INFECTION" BUT IT WAS JUST THE START OF ONE. HE TOOK PYRIDIUM FOR 2 DAYS AND HE SAID HE SWITCHED TO TYLENOL AND THEN DID COMPLETE A 10 DAYS WORTH OF ANTIBIOTICS PRESCRIBED BY THE MD AND HIS SYMPTOMS HAD GONE AWAY QUICKLY. BY THAT TIME HE WAS DONE WITH THE CASE OF CATHETERS AND IT WAS ONLY WHEN HE STARTED ON A NEW CASE IS WHEN HE NOTICED THE FEELING OF THE LUBRICANT BEING MUCH MORE SLIPPERY, MUCH BETTER LIKE WHAT HE WAS USED TO AND CAUSED NO DRAG AT AL

  Patient problems: Urinary Tract Infection

  MAUDE report 17583442 ↗
• MalfunctionJun 30, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  END USER REPORTS "INSIDE THE SEALED KIT WAS AN ITEM THAT LOOKED LIKE A PIECE OF PACKING TAPE THAT HAD DIRT AND OTHER DEBRIS ADHERED TO IT. THE ITEM WAS ON TOP OF THE FOLDED NAPKIN." THE END USER DID NOT USE THE PRODUCT BUT DISCARDED IT. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875954 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "THE CATHETERS CAUSED HIM TO HAVE A UTI. HIS UTI SYMPTOMS WERE NAUSEA, CLOUDY URINE, FREQUENCY AND URGENCY OF VOIDING ONLY CATHING OUT SMALL AMOUNTS FREQUENTLY." HE STATES HE USED "SEVERAL CS14 CATHETERS FOR 1 WEEK, SAME REFERENCE NUMBER, UNKNOWN MARKET UNITS, UNAVAILABLE LOT NUMBERS. HE IS VERY FAMILIAR WITH THE CLOSED SYSTEM CATHETERS AND IS FOLLOWING PROPER CATHERIZATION TECHNIQUE. HE IS HANDWASHING PRIOR TO CATHING, USING GLOVES AND WIPES HEAD OF PENIS WITH ANTIBACTERIAL WIPE PRIOR. HE IS MINDFUL NOT TO TOUCH THE CATHETERS ON ANYTHING WHEN/PRIOR TO INSERTING CATHETER. WIFE STATES HE HAS HAD A HISTORY OF MULTIPLE UTIS IN THE PAST EVEN WHEN USING HIS USUAL BARD CATHETERS. HE HAS DIAGNOSIS OF CKD III. HE CALLED HIS DOCTOR AND THEY HAD HIM GO TO OUTPATIENT LAB FOR URINE TESTING , URINALYSIS AND URINE CULTURE AND HE WAS PRESCRIBED AN ANTIBIOTIC WHICH CLEARED UP HIS UTI SYMPTOMS. HE DISCONTINUED USE OF CATHETER AND HAS HIS REGULAR BARD CATHETERS BACK THAT HE WISHES TO CONTINUE USING."

  Patient problems: Nausea; Urinary Tract Infection

  MAUDE report 13669641 ↗
• InjuryMar 4, 2022Sharp Edges; Sharp Edges

  END USERREPORTS THAT "SHE DEVELOPED BLEEDING WHILE USING CATHETER WHICH REQUIRED HOSPITALIZATION. SHE HAS BEEN USING THIS CATHETER FOR MORE THAN A YEAR S/P C4 QUADRIPLEGIC DIAGNOSIS AND NEUROGENIC BLADDER, SHE REPORTS THAT ON WEDNESDAY SHE DEVELOPED BRIGHT RED BLOOD WHEN USING CATHETER. SHE CATHETERIZES 7 X'S PER DAY FROM HER CONTINENT DIVERSION STOMA. WHEN SHE CATHETERIZED THE NEXT TIME SHE CONTINUED TO HAVE BRIGHT RED BLOOD THAT FILLED THE COLLECTION BAG AND REPORTS THAT BLOOD BY END OF THE DAY APPEARED DARKER IN COLOR. SHE WAS ADMITTED TO THE HOSPITAL FOR THIS ISSUE AND HAD A CT SCAN AND UA C AND S. MD BEGAN IV ANTIBIOTICS AND ADVISED CONSUMER THAT BASED ON CT SCAN HE BELIEVED THE CATHETER EYELETS WERE CAUSING DAMAGE TO THE BLADDER WALLS RESULTING IN BLEED AND INFECTION. SHE WAS DISCHARGED ON SATURDAY AND CHANGED TO AN ALTERNATE BRAND OF CATHETER. HER BLEED HAS RESOLVED. SHE DID NOT NOTICE ANYTHING SPECIFICALLY DIFFERENT IN APPEARANCE ABOUT THESE CATHETERS BUT NOTES THAT SOMETIMES THE FRENCH SIZE APPEARS SMALLER IN DIAMETER. SHE HAS NEVER MEASURED AND ALL PACKAGES ARE 14FRENCH."

  Patient problems: Tissue Breakdown

  MAUDE report 13668058 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "HE HAS HAD SEVERAL UTIS WHILE USING THIS CATHETER. LAST ONE BEING A MONTH AGO, TREATED WITH ANTIBIOTICS. HE HAS BEEN USING THIS CATHETER FOR THE LAST 5 YEARS. HE HAS NOT BEEN INTO SEE HIS UROLOGIST FOR THE LAST 10 MONTHS AND HAS A HISTORY OF BLADDER STONES. HE HAS BEEN TREATED BY HIS PRIMARY DOCTOR WHO HAS BEEN PERFORMING BLADDER SCANS AFTER THE ANTIBIOTICS ARE COMPLETED AND PER END USER, "SCAN IS STILL SHOWING INFECTION." HE HAS BEEN USING THE STERILE GLOVES AND IODINE SWABS PRIOR TO CATHETERIZATION." CONSUMER STATES HE HAS BEEN "GETTING A LOT OF UTIS CAUSED FROM TECHNIQUE." END USER WAS ADVISED HIM TO FOLLOW UP WITH HIS UROLOGIST.

  Patient problems: Urinary Tract Infection

  MAUDE report 13666420 ↗