CURE ULTRA CATHETERRecalls & reported problems across all models

We found 4 models of CURE ULTRA CATHETER by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2018 and Sep 9, 2026 — classified as 74 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (50 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CURE ULTRA CATHETER problems

CURE ULTRA CATHETER models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CURE ULTRA CATHETER ULTRA14

  Catheter, Urological
  102 reports
• CURE ULTRA CATHETER ULTRA16

  Catheter, Urological
  14 reports
• CURE ULTRA CATHETER ULTRA10

  Catheter, Urological
  6 reports
• CURE ULTRA CATHETER ULTRA12

  Catheter, Urological
  4 reports

Recent CURE ULTRA CATHETER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported "patient is keeping UTI's for a long while now and has to stay on antibiotics all the time". No lot number provided.

  Patient problems: Urinary Tract Infection

  MAUDE report 50693528 ↗
• InjuryJan 9, 2026Adverse 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 24027312 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE "CONTINUED TO HAVE RECURRENT UTIS MANY MONTHS IN A ROW MONTH DIAGNOSED AT URGENT CARES AND HER MD SINCE WE LAST SPOKE. SHE SAID SHE HAD ONE DIAGNOSED EACH MONTH IN (B)(6)T AND FEELS LIKE SHE HAS ANOTHER ONE NOW IN NOVEMBER. THE URINE CULTURES ALWAYS GROW OUT THE SAME BACTERIA THE LAST FEW MONTHS, KLEBSIELLA PNEUMONIAE. HER SYMPTOMS ARE ALWAYS URGENCY FREQUENCY AND BURNING. FOR HER PRIOR UTIS IN (B)(6) SHE SAID SHE ALWAYS FELT BETTER FOR A FEW WEEKS AFTER ANTIBIOTIC TREATMENT BEFORE THE NEW ONE STARTED. HER SYMPTOMS RETURNED AGAIN IN (B)(6). THE END OF (B)(6) AFTER A TREATMENT COURSE OF ANTIBIOTICS FOR A POSITIVE UTI (STATED SHE WAS STARTED ON CEFINDIR BUT WHEN THAT CAME BACK AS RESISTANT AND SHE WAS SWITCHED TO ANOTHER ANTIBIOTIC - NAME CNO) SHE SAID SHE DID CHECK HER URINE CULTURE AND IT SHOWED NO GROWTH BUT SHE STILL FELT SYMPTOMATIC. SHE SAID SHE RECENTLY WENT TO URGENT CARE TO DO ANOTHER URINE TEST DUE TO HER SYMPTOMS NOT GOING AWAY AND HAS YET TO HEAR BACK ON MOST RECENT RESULTS BUT SUSPECTS ANOTHER UTI. SHE SAW HER UROLOGIST (B)(6) IN PERSON FOR FOLLOW UP BUT THEY ARE JUST MONITORING HER. SHE STILL HAS A SMALL KIDNEY STONE THEY ARE MONITORING AS WELL." SH

  Patient problems: Urinary Tract Infection

  MAUDE report 23521604 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE "CONTINUED TO HAVE RECURRENT UTIS MANY MONTHS IN A ROW MONTH DIAGNOSED AT URGENT CARES AND HER MD SINCE WE LAST SPOKE. SHE SAID SHE HAD ONE DIAGNOSED EACH MONTH IN AUG, SEPT, OCT AND FEELS LIKE SHE HAS ANOTHER ONE NOW IN NOVEMBER. THE URINE CULTURES ALWAYS GROW OUT THE SAME BACTERIA THE LAST FEW MONTHS, KLEBSIELLA PNEUMONIE. HER SYMPTOMS ARE ALWAYS URGENCY FREQUENCY AND BURNING. FOR HER PRIOR UTIS IN AUG AND SEPT SHE SAID SHE ALWAYS FELT BETTER FOR A FEW WEEKS AFTER ANTIBIOTIC TREATMENT BEFORE THE NEW ONE STARTED. HER SYMPTOMS RETURNED AGAIN IN OCTOBER. THE END OF OCTOBER (B)(6) AFTER A TREATMENT COURSE OF ANTIBIOTICS FOR A POSITIVE UTI (STATED SHE WAS STARTED ON CEFINDIR BUT WHEN THAT CAME BACK AS RESISTANT AND SHE WAS SWITCHED TO ANOTHER ANTIBIOTIC - NAME CNO) SHE SAID SHE DID CHECK HER URINE CULTURE AND IT SHOWED NO GROWTH BUT SHE STILL FELT SYMPTOMATIC. SHE SAID SHE RECENTLY WENT TO URGENT CARE TO DO ANOTHER URINE TEST DUE TO HER SYMPTOMS NOT GOING AWAY AND HAS YET TO HEAR BACK ON MOST RECENT RESULTS BUT SUSPECTS ANOTHER UTI. SHE SAW HER UROLOGIST ON (B)(6) IN PERSON FOR FOLLOW UP BUT THEY ARE JUST MONITORING HER. SHE STILL HAS A SMALL KIDNEY STONE THEY ARE

  Patient problems: Urinary Tract Infection

  MAUDE report 23521598 ↗
• 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 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER IS A 70 YR OLD FEMALE WITH MS. SHE REPORTS SHE HAS BEEN CATHING 2 X A DAY FOR RETENTION FOR 2 YRS NOW. SHE STATES SHE HAS ALWAYS USED THE ULTRA14 AND IT HAS WORKED WELL FOR HER WHEN SHE IS ABLE TO GET IT IN HER URETHRA. SHE IS NOT BLAMING THE CATHETER FOR HER UTIS. SHE HAS DIFFICULTY AT TIMES FOR HER ENTIRE 2 YRS FINDING HER URETHRA. THIS OCCURS OFF AND ON. SHE HAS A SMALL MIRROR BUT OFTEN WILL TRY TO INSERT THE CATHETER 2 - 3 TIMES BEFORE FINDING THE CORRECT URETHRAL OPENING. ONCE IN, IT WILL DRAIN WELL AND SHE HAS NO COMPLAINTS WITH THE PRODUCT ITSELF, IT IS FINDING THE CORRECT SPOT TO PLACE IT IN. SHE ALSO IS GOOD ABOUT ALWAYS CLEANSING HER GENITAL AREA WITH A FRAGRANCE FREE COTTONELLE BRAND WIPE FOR CLEANSING PRIOR TO INSERTION. SHE REPORTS MOST RECENTLY SHE HAD A DIAGNOSED UTI ABOUT 4 WEEKS AGO. SHE WAS PREVIOUSLY ON LOW DOSE NITROFURANTOIN PRESCRIBED BY HER UROLOGIST FOR PROPHYLAXIS UTI PREVENTION SHE ESTIMATES FOR ABOUT 6 MONTHS PRIOR TO THE START OF THIS THIS PAST UTI. SHE SAID IT MUST HAVE STOPPED WORKING FOR HER AS SHE BECAME SYMPTOMATIC OF A UTI WITH URGENCY, FREQUENCY, MALODOROUS URINE AND DARK BROWN COLORED URINE OUTPUT. HER UROLOGIST HAD HER DO A URINE SPECIM

  Patient problems: Urinary Tract Infection

  MAUDE report 23388175 ↗

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