CURE ULTRA CATHETER ULTRA16Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00815947020451), received between Jan 20, 2022 and Oct 27, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389059 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389058 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389057 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389054 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389053 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389052 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389051 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389027 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389025 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THE CATHETER IS VERY HARD TO REMOVE FROM THE PLASTIC. SHE SAYS THAT IT IS HARD TO OPEN THE PERFORATED PLASTIC BLISTER PACK AND SOMETIMES BOTH SIDES OF THE CATHETER PLASTIC BLISTER PACK ARE PERFORATED. SHE SAYS THAT SHE HAS HAD TO CUT THE OTHER SIDE OF THE BLISTER PACK. SHE MENTIONED THAT SHE HAD TO DO THIS BECAUSE THE CATHETER WAS HARD TO REMOVE FROM THE BLISTER PACK. SHE SAYS SHE WILL BE SENDING PICTURES. SHE ALSO SAYS THAT BECAUSE THE PERFORATED SIDE OF THE PLASTIC IS HARD TO OPEN, THE PLASTIC BLISTER PACK RIPS AND LEAVES PIECES OF PLASTIC ON THE CATHETER FUNNEL. SHE THEN HAS TO DISCARD THESE. SHE SAYS THAT THIS IS COSTLY. NO HARM REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23389023 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 19115161 ↗
• InjuryJan 25, 2023Off-Label Use; Off-Label Use

  CONSUMER STATED SHE ENDED UP GETTING A UTI SHE THINKS WAS "BREWING FOR A FEW WEEKS" AND ENDED UP GOING TO THE EMERGENCY ROOM LAST WEEK (B)(6) 2022 AS SHE SAID SHE WAS HYPERVENTILATING FROM ANXIETY AND HAD FELT OVERALL NOT WELL FOR THE LAST FEW WEEKS. IT WAS CONFIRMED WITH URINE TESTING UA AND URINE CULTURE SHE HAD A UTI FROM ER. HER ONLY UTI SYMPTOM WAS HAVING FREQUENCY VOIDING. SHE TOLD ME SHE CANNOT BE SURE WHAT CAUSED HER UTI BUT POSSIBLY THE ULTRA16 COULD HAVE CONTRIBUTED TO HER UTI AS SHE SAID SHE THINKS BECAUSE THEY WERE SO MESSY AND SHORT NOT DRAINING HER BLADDER ALL THE WAY AS DESCRIBED IN THE COMPLAINT DETAILS FOR THIS CASE. SHE SAID SHE MAY HAVE ALSO TOUCHED THE ENTRANCE TO HER URETHRA WHILE CATHING WITH THE ULTRA16 AS IT WAS SO SHORT WITH A NAIL SHE HAS THAT IS INFECTED AND SPLIT AND SHE IS ¿TREATING WITH A POMADE¿. SHE SAID SOMETIMES SHE CANNOT WASH HER HANDS PRIOR TO CATHING AND WILL USE A "99% WATER" GENTLE BABY WIPE TO WIPE HER HANDS AND SHE ALSO USES ONE TO CLEANSE URETHRA PRIOR AND AFTER CATHING. AT ER THEY CHECKED HER URINE AND IT WAS POSITIVE FOR UTI AND SHE IS FINISHING UP A ROUND OF 7 DAY ANTIBIOTICS PRESCRIBED, SHE DOES NOT KNOW THE NAME OF IT BUT IS FEELING B

  Patient problems: Urinary Tract Infection

  MAUDE report 16240769 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "THESE CATHETERS ULTRA16 HAVE TOO MUCH LUBRICANT THAT IS GETTING STUCK IN THE EYELETS IMPEDING HER DRAINING; AND SHE THINKS POSSIBLY CONTRIBUTING TO RECENT MULTIPLE RECENT UTIS AS SHE CANNOT EMPTY HER BLADDER FULLY. SHE STATES SHE "HAS CATHED FOR 3-4 YEARS FOR INCONTINENCE, CATHING 4-5 X DAY. SHE SAID SHE NOTED AFTER SHE STARTED USING THEM SHE FEELS LIKE THEY DON'T DRAIN HER COMPLETELY BECAUSE SHE FEELS THE LUBRICANT IS TOO THICK ON THEM WHEN SHE EXAMINED THEM CLOSELY IT LOOKS LIKE LUBE CLOGS THE EYELETS PRIOR TO USE. SHE SAID SHE WOULD ALWAYS GET 8 OZ OUT IN AM FIRST CATH AND THEN 4-6 OZ THROUGH THE DAY WITH HER BARD BUT NOW WITH THIS SHE ONLY GETS 3 OZ IN AM AND 1-2 OZ EACH TIMES SHE CATHS. " SHE SAID "THE LUBRICANT ON ALL OF THEM LOOK "OLD LOOKING" VERY THICK, TOO THICK AND THE FUNNELS LOOK FLATTENED WHEN REMOVING FROM PACKAGING. SHE SAID SHE ONLY "GETS A LITTLE (URINE) OUT AND CAN'T GET IT GOING AGAIN" WHICH SHE SAID CAUSES HER TO HAVE INCREASED FREQUENCY WITH THE URGE TO CATH EVERY 1-2 HRS. AS FAR AS SHE KNOWS THEY HAVE NOT BEEN IN ANY EXTREME TEMPS.". SHE SAID SHE ALSO RECENTLY GOT UTIS AND THESE MAY HAVE CONTRIBUTED TO THAT. SHE TYPICALLY GETS UTIS IN THE PA

  Patient problems: Urinary Tract Infection

  MAUDE report 15666786 ↗
• InjuryJan 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY PRODUCT END USER TO PRODUCT DISTRIBUTOR THAT WHEN SHE USED THE CATHETER SHE "SPOTTED" BLOOD ON THE CATHETER DURING CATHETERIZATION. THE END USER REPORTS SHE DEVELOPED A URINARY TRACT INFECTION WHICH SHE ATTRIBUTES TO THE CATHETER. PER THE END USER HER URINE BECAME "CLOUDY AND ODOROUS AND SHE HAD A BURNING SENSATION TO THE URETHRA". END USER STATES HER HEALTHCARE PROVIDER DID A URINALYSIS AND CULTURE AND WAS "POSITIVE FOR INFECTION". THE END USER WAS PRESCRIBED "CIPRO", SHE REPORTS HER SYMPTOMS RESOLVED. THERE WAS NO KNOWN MALFUNCTION REPORTED FOR THE CAUSE OF INFECTION. NO PHOTOGRAPHS OR LABORATORY DOCUMENTATION DEPICTING THE REPORTED COMPLAINT ISSUE. LOT UNKNOWN.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 13308962 ↗