CURE CATHETER HM12CRecalls & reported problems
Convatec, Purchasing Department · Hydrophilic, Male, 16”, Coude Tip · Class 2
All models of CURE CATHETER (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Cure Catheter HM12C is a hydrophilic male urinary catheter with a curved tip for home catheterization. Most of the 74 reports describe catheters that are hard to pull back out and packaging that will not peel open cleanly, tearing or sticking, plus some sharp edges. Ten injuries were reported, including urinary tract infections, rash, pain and bleeding, with no deaths. No recalls name this device. Reports rose sharply, from 6 in the prior 12 months to 32 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 74
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00815947020338), received between Aug 30, 2022 and Feb 4, 2026 — classified as 10 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (34 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, 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove34
- Tear, Rip or Hole in Device Packaging28
- Adverse Event Without Identified Device or Use Problem6
- Sharp Edges4
- Device Handling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- Urinary Tract Infection10
- Rash4
- Hemorrhage/Blood Loss/Bleeding2
- Pain2
- Sepsis2
Recent adverse event reports
The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2026Device Handling Problem
END USER'S WIFE REPORTS "SHE FOUND THE ULTRAM12C EXTREMELY HARD TO OPEN THE PACKAGING. SHE CATHS HER HUSBAND. SHE STRUGGLES WITH RHEUMATOID ARTHRITIS AS WELL. SHE SAID SHE WAS UNABLE TO TEAR OPEN THE PACKAGING AND HAD TO USE SCISSORS TO OPEN PACKAGING AND THINKS THIS MAY HAVE CONTAMINATED THE CATHETER AND FEELS LIKE THIS COULD HAVE CONTRIBUTED TO A UTI HE WAS DIAGNOSED WITH SHORTLY AFTER TRIALING THESE. SHE COULD REALLY NOT REMEMBER ANY SPECIFIC DETAILS ABOUT THIS UTI AS IN HIS PAST HE HAS HAD SO MANY HE HAS NEEDED ORAL TREATMENT FOR BUT MOST LIKELY THAT WAS THE CASE. HIS UTIS ARE DIAGNOSED BY CATH'D SPECIMEN SHE BRINGS TO LAB WITH MD ORDER."
Patient problems: Urinary Tract Infection
MAUDE report 24259674 ↗InjuryFeb 4, 2026Device Handling Problem
END USER'S WIFE REPORTS "SHE FOUND THE ULTRAM12C EXTREMELY HARD TO OPEN THE PACKAGING. SHE CATHS HER HUSBAND. SHE STRUGGLES WITH RHEUMATOID ARTHRITIS AS WELL. SHE SAID SHE WAS UNABLE TO TEAR OPEN THE PACKAGING AND HAD TO USE SCISSORS TO OPEN PACKAGING AND THINKS THIS MAY HAVE CONTAMINATED THE CATHETER AND FEELS LIKE THIS COULD HAVE CONTRIBUTED TO A UTI HE WAS DIAGNOSED WITH SHORTLY AFTER TRIALING THESE. SHE COULD REALLY NOT REMEMBER ANY SPECIFIC DETAILS ABOUT THIS UTI AS IN HIS PAST HE HAS HAD SO MANY HE HAS NEEDED ORAL TREATMENT FOR BUT MOST LIKELY THAT WAS THE CASE. HIS UTIS ARE DIAGNOSED BY CATH'D SPECIMEN SHE BRINGS TO LAB WITH MD ORDER."
Patient problems: Urinary Tract Infection
MAUDE report 24259672 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233551 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
TO DATE, NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233514 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233510 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233487 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233436 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233432 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233428 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233307 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233266 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233263 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233164 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233119 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233114 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233111 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233099 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233058 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233054 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233039 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233036 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233028 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232989 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232986 ↗MalfunctionFeb 2, 2026Tear, Rip or Hole in Device Packaging
END USER'S WIFE REPORTS "CATHETERS ARE NOT PEELING OPEN EVENLY, IT IS LIKE THE CATHETERS PACKAGING HAS ADHESIVE ISSUES OR PAPER ISSUES. THE PAPER WILL STICK TO ONE OR BOTH OF THE SIDES AND TEAR AS SHE IS PEELING IT OPEN AND PAPER WILL TEAR UNEVENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232983 ↗
Other Catheter, Straight devices
- Magic3 Go Male Catheter with SureGrip 53814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall490 reports
- Magic3 Go Male Coude Catheter with SureGrip 50814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall3 deaths416 reports
- Magic3 Go™ Intermittent Urinary Catheter 51814C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall327 reports
- Magic3 Go Male Coude Catheter with SureGrip 50816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall239 reports
- Magic3 Go Male Catheter with SureGrip 53816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall164 reports
- Magic3 Go Male Catheter with SureGrip 53812GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall120 reports
- Magic3 Go™ Intermittent Urinary Catheter 51812C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall109 reports
- CURE CATHETER HM14Convatec, Purchasing Department · Catheter, Straight154 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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