CURE CATHETER HP12Recalls & reported problems
Convatec, Purchasing Department · Hydrophilic, Pediatric, 10”, Straight Tip · Class 2
All models of CURE CATHETER (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947021007), received between Jan 14, 2021 and Jan 14, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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 16, 2026.
Most reported problems
Device problems
- Contamination of Device Ingredient or Reagent1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
INTERMITTENT CATHETER PATIENT (USER) REPORTED FINDING A WHITE SUBSTANCE PRIOR TO CATHETER USE AND HAD A URINARY TRACT INFECTION (UTI). DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED A ONE-DAY DOSE ANTIBIOTIC TWICE, BUT THEY WERE NOT EFFECTIVE. SHE WAS GIVEN A COURSE OF BACTRIM, AND IS UNSURE IF THE INFECTION WAS FULLY RESOLVED. SHE WILL RETURN TO HER DOCTOR TO HAVE HER URINE TESTED TO ENSURE SHE IS COMPLETELY RECOVERED.
Patient problems: Urinary Tract Infection
MAUDE report 11174858 ↗
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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