CURE ULTRA MALE CATHETERRecalls & reported problems across all models

We found 10 models of CURE ULTRA MALE CATHETER by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 157 adverse event reports in the FDA's MAUDE database, received between Sep 7, 2018 and Jul 13, 2026 — classified as 75 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (51 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 MALE CATHETER problems

CURE ULTRA MALE CATHETER models

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

• CURE ULTRA MALE CATHETER ULTRA M12C

  Catheter, Straight
  51 reports
• CURE ULTRA MALE CATHETER ULTRA M14

  Catheter, Urological
  39 reports
• CURE ULTRA MALE CATHETER ULTRA M14C

  Catheter, Straight
  28 reports
• CURE ULTRA MALE CATHETER ULTRA M16

  Catheter, Urological
  20 reports
• CURE ULTRA MALE CATHETER ULTRA M16C

  Catheter, Straight
  10 reports
• CURE ULTRA MALE CATHETER ULTRA M18C

  Catheter, Straight
  3 reports
• CURE ULTRA MALE CATHETER ULTRA M18

  Catheter, Urological
  2 reports
• CURE ULTRA MALE CATHETER ULTRA M10C

  Catheter, Straight
  2 reports
• CURE ULTRA MALE CATHETER ULTRA M10

  Catheter, Urological
  1 report
• CURE ULTRA MALE CATHETER ULTRA M12

  Catheter, Urological
  1 report

Recent CURE ULTRA MALE CATHETER adverse event reports

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

• MalfunctionJul 13, 2026Difficult to Remove

  Patient problems: Discomfort

  MAUDE report 25795418 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES HE "HAS BEEN CATHING SINCE (B)(6) 2025 WITH THE ULTRAM14C CATHETER. HE JUST PREVIOUSLY HAD PAE PROCEDURE FOR HIS BPH ON (B)(6) 2025. HE HAD A FOLEY POST OP, IT WAS REMOVED AFTER A FEW DAYS AND HE ENDED UP FAILING THAT VOIDING TRIAL. HE SAID A NEW FOLEY WAS PLACED HOWEVER HE ENDED UP GETTING A BAD UTI END OF OCTOBER WITH SHAKING CHILLS AND FEVER FROM IT. HE SAID THAT WAS SUCCESSFULLY TREATED HIS SYMPTOMS OF THAT UTI AND REMOVED AND HE STARTED CIC. HE SAID SINCE HE STARTED CIC HE HAS HAD 2 ADDITIONAL UTIS WITH HIS INTERMITTENT CATHETERS FOLLOWING THE FIRST ONE POST OP WITH THE FOLEY. HIS SYMPTOMS POST FOLEY INFECTION CLEARED WITH ANTIBIOTIC TREATMENT. THEN END OF (B)(6) 2025 HE NOTICED HE HAD CLOUDY URINE THAT WAS FOUL SMELLING AND A URINE CULTURE WAS CHECKED WHICH WAS POSITIVE FOR ENTEROCOCCUS AND HE WAS TREATED WITH MACROBID. HE SAID THE ANTIBIOTIC HELPED A LOT TO CLEAR HIS URINE CLOUDINESS BUT NOT SURE IF IT EVER FULLY CLEARED UP POST TREATMENT. HE SAID HE WENT INTO SEE HIS UROLOGIST LAST THURSDAY BECAUSE HE HAD AN EPISODE WEDNESDAY NIGHT WHERE HE PLACED THE CATHETER IN HIM AND URINE SPRAYED OUT ALL AROUND THE CATHETER AND IT WAS HARD TO INSERT AND UNCOMFORTABLE. H

  Patient problems: Urinary Tract Infection

  MAUDE report 24208631 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES HE "HAS BEEN CATHING SINCE (B)(6) 2025 WITH THE ULTRAM14C CATHETER. HE JUST PREVIOUSLY HAD PAE PROCEDURE FOR HIS BPH ON (B)(6) 2025. HE HAD A FOLEY POST OP, IT WAS REMOVED AFTER A FEW DAYS AND HE ENDED UP FAILING THAT VOIDING TRIAL. HE SAID A NEW FOLEY WAS PLACED HOWEVER HE ENDED UP GETTING A BAD UTI END OF (B)(6) WITH SHAKING CHILLS AND FEVER FROM IT. HE SAID THAT WAS SUCCESSFULLY TREATED HIS SYMPTOMS OF THAT UTI AND REMOVED AND HE STARTED CIC. HE SAID SINCE HE STARTED CIC HE HAS HAD 2 ADDITIONAL UTIS WITH HIS INTERMITTENT CATHETERS FOLLOWING THE FIRST ONE POST OP WITH THE FOLEY. HIS SYMPTOMS POST FOLEY INFECTION CLEARED WITH ANTIBIOTIC TREATMENT. THEN END OF (B)(6) 2025 HE NOTICED HE HAD CLOUDY URINE THAT WAS FOUL SMELLING AND A URINE CULTURE WAS CHECKED WHICH WAS POSITIVE FOR ENTEROCOCCUS AND HE WAS TREATED WITH MACROBID. HE SAID THE ANTIBIOTIC HELPED A LOT TO CLEAR HIS URINE CLOUDINESS BUT NOT SURE IF IT EVER FULLY CLEARED UP POST TREATMENT. HE SAID HE WENT INTO SEE HIS UROLOGIST LAST THURSDAY BECAUSE HE HAD AN EPISODE WEDNESDAY NIGHT WHERE HE PLACED THE CATHETER IN HIM AND URINE SPRAYED OUT ALL AROUND THE CATHETER AND IT WAS HARD TO INSERT AND UNCOMFORTABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 24208630 ↗
• MalfunctionJan 7, 2026Product Quality Problem

  PATIENT STATED WITH EVERY ORDER THERE IS AT LEAST TWO TO THREE CATHETERS THAT ARE DRY. PATIENT HAS USED BEFORE. NO LOT NUMBER GIVEN. THIS EMDR COVERS THE UNKNOWN ACTUAL NUMBER OF DRY CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989962 ↗
• MalfunctionJan 7, 2026Product Quality Problem

  PATIENT STATED WITH EVERY ORDER THERE IS AT LEAST TWO TO THREE CATHETERS THAT ARE DRY. PATIENT HAS USED BEFORE. NO LOT NUMBER GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989961 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749974 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749536 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749530 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN.".

  Patient problems: Pain

  MAUDE report 23749468 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749465 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749463 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749460 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749458 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749457 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749456 ↗

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