CURE CATHETER HM16Recalls & reported problems
Convatec, Purchasing Department · Hydrophilic, Male, 16”, Straight Tip · Class 2
Quick summary
This Convatec Cure Catheter HM16 is a hydrophilic male straight-tip urinary catheter. The 46 reports mostly describe catheters sticking to their packaging near the tip, along with packaging tears and a catheter sticking in the urethra on removal. Eleven reports involved injuries, including urinary tract infections, blood in the urine and pain, with no deaths. There are no recalls naming 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
- 46
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00815947020321), received between Dec 7, 2017 and Feb 8, 2026 — classified as 11 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (28 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem28
- Adverse Event Without Identified Device or Use Problem9
- Tear, Rip or Hole in Device Packaging4
- Insufficient Device Problem Information2
- Difficult to Remove1
- Off-Label Use1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Urinary Tract Infection11
- Hematuria3
- Fever1
- Pain1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2026Adverse Event Without Identified Device or Use Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Urinary Tract Infection
MAUDE report 24288261 ↗MalfunctionJun 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
END USER REPORTS UNKNOWN QTY OF CATHETERS STICKING TO PACKAGING. HE REPORTS THE CATHETER TIP AREA IS STICKING INSIDE THE CATHETER PACKAGING WHEN HE GOES TO REMOVE THEM FROM PACKAGING (AFTER HAVING ACTIVATED AND ENSURED THEY WERE HYDRATED/PREPPED AS USUAL WITH THIS PRODUCT). HE SAID HE DID NOT FORCE THEM OUT OF PACKAGING OR TRY TO USE THEM AT ALL WHEN HE NOTED THIS OCCURRING IN A RECENT ORDER. HE SAID HE COUNTED 11 TOTAL CATHETERS FROM 2 BOXES THAT HAD THIS ISSUE BUT ONLY MADE NOTE OF THE LOT NUMBER OF 1 BOX AND NOT THE OTHER. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294489 ↗MalfunctionJun 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
END USER REPORTS UNKNOWN QTY OF CATHETERS STICKING TO PACKAGING. HE REPORTS THE CATHETER TIP AREA IS STICKING INSIDE THE CATHETER PACKAGING WHEN HE GOES TO REMOVE THEM FROM PACKAGING (AFTER HAVING ACTIVATED AND ENSURED THEY WERE HYDRATED/PREPPED AS USUAL WITH THIS PRODUCT). HE SAID HE DID NOT FORCE THEM OUT OF PACKAGING OR TRY TO USE THEM AT ALL WHEN HE NOTED THIS OCCURRING IN A RECENT ORDER. HE SAID HE COUNTED 11 TOTAL CATHETERS FROM 2 BOXES THAT HAD THIS ISSUE BUT ONLY MADE NOTE OF THE LOT NUMBER OF 1 BOX AND NOT THE OTHER. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22290369 ↗MalfunctionJun 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
END USER REPORTS UNKNOWN QTY OF CATHETERS STICKING TO PACKAGING. HE REPORTS THE CATHETER TIP AREA IS STICKING INSIDE THE CATHETER PACKAGING WHEN HE GOES TO REMOVE THEM FROM PACKAGING (AFTER HAVING ACTIVATED AND ENSURED THEY WERE HYDRATED/PREPPED AS USUAL WITH THIS PRODUCT). HE SAID HE DID NOT FORCE THEM OUT OF PACKAGING OR TRY TO USE THEM AT ALL WHEN HE NOTED THIS OCCURRING IN A RECENT ORDER. HE SAID HE COUNTED 11 TOTAL CATHETERS FROM 2 BOXES THAT HAD THIS ISSUE BUT ONLY MADE NOTE OF THE LOT NUMBER OF 1 BOX AND NOT THE OTHER. NO PHOTO AVAILABLE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288624 ↗MalfunctionJun 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
END USER REPORTS UNKNOWN QTY OF CATHETERS, "ALMOST TWO DOZEN", STICKING TO PACKAGING, WHEN THIS FIRST OCCURRED 4-5 YRS AGO. ADDITIONALLY, HE STATES THE CATHETER TIP AREA WAS STICKING INSIDE THE CATHETER PACKAGING. HE SAID HE ALWAYS PREPS THE CATHETER BY BURSTING THE STERILE WATER PACKET TO HYDRATE THE CATHETER WELL AND THEN GOES TO REMOVE THE CATHETER FROM PACKAGE TO USE IT. WHEN HE FIRST NOTICED THEM STICKING TO THE PACKAGING NEAR THE TIP AFTER PREPPING THE CATHETER (AGAIN, THIS OCCURRED 4- 5 YRS AGO AND NO PRIOR COMPLAINT CASES ON FILE) HE JUST JERKED IT OUT OF THE PACKAGING AND USED IT. UPON PASSING IT THROUGH HIS URETHRA HE SAID HE HAS TO ALWAYS PUSH IT THROUGH HIS STRICTURE AND HE SAID IT FELT LIKE IT CUT HIM ABOUT 6-8 INCHES INSIDE HIS URETHRA. WHEN HE PULLED IT OUT, HE SAID BECAUSE THE TIP HAD STUCK TO THE BOTTOM OF THE PACKAGING THE TIP WAS ALSO AFFECTED AND IT WAS SHARP "LIKE A KNIFE BLADE." HE SAID HE HAD A LOT OF BLEEDING FOLLOWING THAT CATHETERIZATION AND BLED FOR 3 DAYS AFTER THAT. HE DID GO TO HIS UROLOGIST AT THE TIME AND JUST REMEMBERS BEING GIVEN A ROUND OF ANTIBIOTICS FOR INFECTION PREVENTION BEFORE THE BLEEDING FINALLY STOPPED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22288552 ↗MalfunctionFeb 12, 2025Sharp Edges; Sharp Edges
TO DATE, NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21365155 ↗MalfunctionJan 17, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE EU EXPERIENCED "STICKING IN URETHRA UPON REMOVAL" WITH AN UNKNOWN QUANTITY, UNKNOWN MU'S AND UNKNOWN LOTS OF CURE HM16 CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531409 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182164 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182163 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182092 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182091 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182090 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182088 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182086 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182084 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182083 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182082 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182081 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182079 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181993 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181992 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181991 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181990 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181988 ↗MalfunctionJun 22, 2023Product Quality Problem; Product Quality Problem
¿CUSTOMER STATED THE PRODUCTS HAD NO LUBRICANT.¿ NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181987 ↗
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.