CURE CATHETER HP8Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815947020987), received between Jan 29, 2025 and Jan 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (2 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
- Entrapment of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Entrapment of Device; Entrapment of Device
END USER STATES "SOME, ONLY A FEW, COULD NOT QUANTIFY SHE NOTED HAD THE NO TOUCH SLEEVE STUCK INSIDE THE SIDE SEALS OF THE PACKAGING OF THE CATHETER AND TO REMOVE THE CATHETER WITH THE SLEEVE SHE WOULD HAVE TO UNPEEL THE ENTIRE CATHETER PACKAGING APART TO RELEASE THE SLEEVES. SHE USED THEM, NO HARM NOTED." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263130 ↗MalfunctionJan 29, 2025Entrapment of Device; Entrapment of Device
END USER STATES "SOME, ONLY A FEW, COULD NOT QUANTIFY SHE NOTED HAD THE NO TOUCH SLEEVE STUCK INSIDE THE SIDE SEALS OF THE PACKAGING OF THE CATHETER AND TO REMOVE THE CATHETER WITH THE SLEEVE SHE WOULD HAVE TO UNPEEL THE ENTIRE CATHETER PACKAGING APART TO RELEASE THE SLEEVES. SHE USED THEM, NO HARM NOTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263128 ↗
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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