CURE CATHETER HM16CRecalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00815947020352), received between Jan 31, 2019 and Jan 26, 2026 — classified as 7 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (55 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Sharp Edges

  IT WAS REPORTED "CATHETERS STICKING TO PACKAGING CREATING ROUGH, BENT AREA END NEAR TIP OF CATHETER HAS CAUSED LIGHT BLEEDING IN PAST WITH USE. HE SAID THE ISSUE IS "THE CATHETER IS STUCK TO THE PACKAGING, PARTICULARLY THE PLASTIC CLEAR SIDE WHEN HE GOES TO REMOVE THEM FROM PACKAGING AFTER PREPPING THEM. HE SAID HE CAN SEE THEY ARE STUCK TO PACKAGING EVEN PRIOR TO BURSTING WATER SACHET. HE SAID THEY ARE ALSO STUCK IN THE PACKAGING NOT COMPLETELY STRAIGHT BUT CATHETER A BIT BENT, "TURNED ABOUT A SIXTEENTH OF AN INCH" AS THE PART THAT IS STUCK SEEMS "PINCHED OFF AND TURNED". THIS AREA THAT IS STUCK TO THE PACKAGING CREATES A ROUGH AREA ON THE CATHETER IF HE MANAGES TO REMOVE IT FROM THE PACKAGING AND USE IT." UNKNOWN TOTAL QUANTITY. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24177682 ↗
• MalfunctionJan 26, 2026Sharp Edges

  IT WAS REPORTED "CATHETERS STICKING TO PACKAGING CREATING ROUGH, BENT AREA END NEAR TIP OF CATHETER HAS CAUSED LIGHT BLEEDING IN PAST WITH USE. HE SAID THE ISSUE IS "THE CATHETER IS STUCK TO THE PACKAGING, PARTICULARLY THE PLASTIC CLEAR SIDE WHEN HE GOES TO REMOVE THEM FROM PACKAGING AFTER PREPPING THEM. HE SAID HE CAN SEE THEY ARE STUCK TO PACKAGING EVEN PRIOR TO BURSTING WATER SACHET. HE SAID THEY ARE ALSO STUCK IN THE PACKAGING NOT COMPLETELY STRAIGHT BUT CATHETER A BIT BENT, "TURNED ABOUT A SIXTEENTH OF AN INCH" AS THE PART THAT IS STUCK SEEMS "PINCHED OFF AND TURNED". THIS AREA THAT IS STUCK TO THE PACKAGING CREATES A ROUGH AREA ON THE CATHETER IF HE MANAGES TO REMOVE IT FROM THE PACKAGING AND USE IT." UNKNOWN TOTAL QUANTITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24177504 ↗
• MalfunctionDec 5, 2025Unsealed Device Packaging; Unsealed Device Packaging

  END USER REPORTS HE CATHS 4-6 TIMES A DAY FOR RETENTION. HE SAID "HE GETS 540 CATHETERS AT A TIME AS HE GETS A 3 MONTH ORDER AT A TIME. WHEN HE FIRST GOT THIS ORDER (HE IS NEARLY DONE WITH AS HE ONLY HAS 2 BOXES LEFT) A FEW MONTHS AGO, HE SAID HE NOTED THIS CONCERN AND HAS CONTINUED TO USE THEM. HE ESTIMATES ABOUT 1/3 TO 1/2 OF THIS ENTIRE ORDER SO FAR WAS AFFECTED. HE NOTED 2 DIFFERENT LOTS HE FOUND CATHETERS WITH THE SAME ISSUE IN BUT DID NOT KNOW HOW MANY OF EACH MU BOX PER LOT HE RECEIVED. HE SAID THE TIP END OF THE CATHETERS ARE STUCK IN THE SEAL OF THE PACKAGING, SO THIS MAKES THEM STUCK INSIDE WHEN HE GOES TO REMOVE THEM FROM PACKAGING AFTER PREPPING THEM. HE SAID HE HAS TO "YANK THEM" OUT OF PACKAGING. HE SAID DUE TO THIS, THE TIP IS AFFECTED AS IT DOESN'T FEEL AS SMOOTH AS IT SHOULD, FEELS LIKE SOMETHING TINY IS STICKING TO THE TIP. HE SAID GOING IN IT IS OK, NOT TOO MUCH DISCOMFORT BUT UPON REMOVAL, IT WILL FEEL IT SCRATCHING THE LENGTH OF HIS URETHRA ONLY ON THESE THAT ARE AFFECTED. HAS NEVER HAD ANY BLEEDING WITH USE OF THESE EVEN WITH REPORTED DEFECT OR ANY LASTING HARM HE SAID." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: Discomfort

  MAUDE report 23726992 ↗
• MalfunctionDec 5, 2025Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Discomfort

  MAUDE report 23726986 ↗
• MalfunctionDec 5, 2025Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Discomfort

  MAUDE report 23726870 ↗
• MalfunctionDec 5, 2025Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Discomfort

  MAUDE report 23726869 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478322 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478321 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  CONSUMER REPORTS HE "CATHS ON AVERAGE OF 4 X A DAY SOMETIMES A BIT MORE OR LESS BASED ON LIQUID INTAKE. HE IS A LONG TIMES USER OF THIS PRODUCT." HE SAID IN HIS LAST ORDER "HE NOTICED THIS ISSUE REOCCURRING AGAIN WHERE THE CATHETERS ARE STICKING TO THE PACKAGING NEAR TIP AREA TO PACKAGING. HE SAID DESPITE HIM BURSTING THE WATER LIKE USUAL PRIOR TO USE, THE WATER CAN'T BREAK IT LOOSE FROM THE AREA AND THEY TEND TO BE STUCK. HE CAN "MASSAGE IT" LOOSE BUT HAS NOTICED THAT WHEN HE TRIED TO USE A FEW WITH THIS ISSUE IT WOULD CAUSE HIM DISCOMFORT LIKE A SCRATCHING FEELING WITH INSERTION THROUGHOUT HIS URETHRA AND LIGHT BLEEDING NOTED ON REMOVAL SEEN ON CATHETER ITSELF AS THEY HAVE A SHARP BUR LIKE AREA WHERE THEY WERE STUCK TO PACKAGING. HE OPTED TO NOT USE ANYMORE THAT HAD THIS ISSUE. HE SAID THE BLEEDING WAS LIGHT WHEN IT OCCURRED WITH THESE AND FULLY STOPS HIS NEXT 2 CATHS, IT WAS NOT CONTINUOUS. HE DID NOT GO SEE HIS MD REGARDING THIS CONCERN AS HE SAID IT WAS NOT ALARMING ENOUGH FOR HIM TO DO SO."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478315 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  CONSUMER REPORTS HE "CATHS ON AVERAGE OF 4 X A DAY SOMETIMES A BIT MORE OR LESS BASED ON LIQUID INTAKE. HE IS A LONG TIMES USER OF THIS PRODUCT." HE SAID IN HIS LAST ORDER "HE NOTICED THIS ISSUE REOCCURRING AGAIN WHERE THE CATHETERS ARE STICKING TO THE PACKAGING NEAR TIP AREA TO PACKAGING. HE SAID DESPITE HIM BURSTING THE WATER LIKE USUAL PRIOR TO USE, THE WATER CAN'T BREAK IT LOOSE FROM THE AREA AND THEY TEND TO BE STUCK. HE CAN "MASSAGE IT" LOOSE BUT HAS NOTICED THAT WHEN HE TRIED TO USE A FEW WITH THIS ISSUE IT WOULD CAUSE HIM DISCOMFORT LIKE A SCRATCHING FEELING WITH INSERTION THROUGHOUT HIS URETHRA AND LIGHT BLEEDING NOTED ON REMOVAL SEEN ON CATHETER ITSELF AS THEY HAVE A SHARP BUR LIKE AREA WHERE THEY WERE STUCK TO PACKAGING. HE OPTED TO NOT USE ANYMORE THAT HAD THIS ISSUE. HE SAID THE BLEEDING WAS LIGHT WHEN IT OCCURRED WITH THESE AND FULLY STOPS HIS NEXT 2 CATHS, IT WAS NOT CONTINUOUS. HE DID NOT GO SEE HIS MD REGARDING THIS CONCERN AS HE SAID IT WAS NOT ALARMING ENOUGH FOR HIM TO DO SO."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478312 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478238 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478234 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478233 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478232 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478231 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478228 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478227 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478226 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478225 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478224 ↗
• MalfunctionNov 5, 2025Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478223 ↗
• MalfunctionJul 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS CATHETER STUCK TO THE PACKAGING. "THEY ARE STUCK TO THE PACKAGING AND WHEN THE PATIENT PULLS THEM APART, THE PACKAGING HAS SMALL PIECES STUCK TO THE CATHETER." NO ADDITIONAL INFORMATION WAS PROVIDED. NO PHOTO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639833 ↗
• MalfunctionJul 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS CATHETER STUCK TO THE PACKAGING. "THEY ARE STUCK TO THE PACKAGING AND WHEN THE PATIENT PULLS THEM APART, THE PACKAGING HAS SMALL PIECES STUCK TO THE CATHETER." NO ADDITIONAL INFORMATION WAS PROVIDED. NO PHOTO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631663 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 21560934 ↗
• MalfunctionMar 3, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED " OVER 50% OF THE BOX TIPS WELDED TO PKG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503524 ↗