CURE CATHETER M16Recalls & reported problems
Convatec, Purchasing Department · Uncoated Male, 16”, Straight Tip · Class 2
Quick summary
This Convatec Cure straight male catheter, 16 inch, is a single-use urinary catheter. Most of the 67 reports describe packaging problems: boxes arriving already opened, or catheters that were not sterile or showed signs of contamination, plus a few mentions of sharp edges. Three reports involve injuries, including bleeding and skin irritation. No deaths were reported, and no recalls name this device.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00815947020048), received between Dec 19, 2019 and Jan 24, 2025 — classified as 3 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (30 reports).
1 other recall cover devices cleared under the same FDA submission (K072539); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging30
- Contamination /Decontamination Problem26
- Delivered as Unsterile Product26
- Sharp Edges8
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Hemorrhage/Blood Loss/Bleeding9
- Urinary Tract Infection3
- Skin Irritation1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED "CONSUMER IS A SCI PATIENT IN A WHEELCHAIR SINCE 1996 AND HAS CATHED FOR MANY YEARS. HAS A VERY SPASTIC BLADDER AND CATHS EVERY 4-6 HRS FOR INCONTINENCE. END USER STATES HE WAS SUPPOSED TO GET THE M14C CATHETER AS THIS HAS BEEN THE CATHETER HE HAS USED FOR YEARS, HOWEVER "HE WAS SENT IN ERROR THE M16 STRAIGHT TIP AND THIS ONE CAUSED HIM THE CONCERNS. HE DOES NOT HAVE ISSUES OF BLEEDING WITH THE M14C AND THIS HAS BEEN A CATHETER HE HAS USED FOR YEARS, HIS PREFERRED CATHETER. HE SAID HE WAS TRAVELING OVERSEAS FOR A CHRISTMAS HOLIDAY SO WHEN HE PACKED HIS CATHETERS, HE DID NOT AT ALL NOTICE THAT SOME HE WAS RECENTLY SENT WERE THE M16 AS THEY WERE ALL IN THE SAME CURE BOXES HE HAS BEEN USED TO. HE SAID HE ONLY HAD A FEW BOXES OF M14C PACKED ALONG WITH HIM BUT THEN WHEN HE RAN OUT OF THOSE OVERSEAS, HE HAD TO USE THE M16. HE HAD ONLY NOTICED THESE WERE A DIFFERENT FR SIZE AND TIP TYPE WHEN HE WAS OVERSEAS. HE SAID HE WOULD APPLY EXTRA KY JELLY TO THEM BUT STILL HARDER TO INSERT AND GET THROUGH SPHINCTER. HE SAID HE HAD OFF AN ON BLEEDING WITH USE OF THEM, VERY LIGHT BLEEDING WITH USE AS THIS WAS NOT HIS CORRECT FR SIZE NOR TIP TYPE. HE SAID HE CANNOT BE SURE WHAT CAUSED
Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection
MAUDE report 21228983 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144099 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144095 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144055 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144053 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144049 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144045 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144040 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144035 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144018 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144014 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144011 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144005 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143975 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143935 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143927 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143925 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143922 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143918 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143916 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143801 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143783 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143778 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143772 ↗MalfunctionNov 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
RETAILER REPORTS THE END USER RECEIVED A BOX OF M16 CATHETERS THAT WERE ALL OPEN. NO ADDITIONAL INFORMATION PROVIDED. NO PHOTO PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18143770 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072539. One submission often covers many models, so check the product and lot details in each record.
- Z-0004-2013 · Sep 19, 2012 · TerminatedMale, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.