CURE CATHETER HM18CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815947021229), received between Aug 30, 2022 and Aug 30, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "CATHETERS ARE STICKING TO CLEAR PLASTIC PACKAGING AND THE HYDROPHILIC COATING IS CREATING SHARP EDGES ON CATHETER WHEN REMOVED FROM PACKAGING AND ONCE CAUSED BLEEDING IN URETHRA. CONSUMER STATES NEARLY EVERY SINGLE BOX HE RECEIVED IN HIS RECENT SHIPMENT AS WELL AS 3 MONTHS AGO HAD THE DEFECT. HE SAID THE MAJORITY OF THE CATHETERS IN ALL BOXES HAVE THE DEFECT. HE SAID THERE IS TYPICALLY ONE SPOT ON THE CLEAR PLASTIC PACKAGING ABOUT 1/8 INCH LONG THAT THE CATHETER IS STUCK TO. HE SAID HE CAN ONLY ASSUME IT IS STUCK THERE EVEN BEFORE HE POPS THE STERILE WATER PACKET. HE HAS TO PULL REALLY HARD TO GET IT OUT AND THIS PROCESS IS NOT SMOOTH AT ALL HE SAID. OFTEN CATHETER WILL RELEASE WITH A SHARP EDGE HE THINKS IS FROM THE COATING/GLUE. HE TRIES TO SMOOTH OUT THE SHARP EDGES WITH PRESSURE. HE CAN FEEL THE SHARP EDGE TO SMOOTH BY THE STUCK PART WHILE IT IS STILL IN THE PACKAGING SO IT DOESN'T BECOME UNSTERILE PRIOR TO USE. HE STARTED DOING THIS BECAUSE ONCE HE DID GET CUT BY USING A CATHETER WITH THIS SHARP EDGE AND HE HAS A LITTLE BIT OF BLEEDING HE SAID THAT LASTED FOR ABOUT 2 CATHS. NO MEDICAL INTERVENTION SOUGHT. HE STATES HE DOES NOT HAVE PAIN WITH USE OF THESE DEFE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15320344 ↗
• MalfunctionAug 30, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "CATHETERS ARE STICKING TO CLEAR PLASTIC PACKAGING AND THE HYDROPHILIC COATING IS CREATING SHARP EDGES ON CATHETER WHEN REMOVED FROM PACKAGING AND ONCE CAUSED BLEEDING IN URETHRA. CONSUMER STATES NEARLY EVERY SINGLE BOX HE RECEIVED IN HIS RECENT SHIPMENT AS WELL AS 3 MONTHS AGO HAD THE DEFECT. HE SAID THE MAJORITY OF THE CATHETERS IN ALL BOXES HAVE THE DEFECT. HE SAID THERE IS TYPICALLY ONE SPOT ON THE CLEAR PLASTIC PACKAGING ABOUT 1/8 INCH LONG THAT THE CATHETER IS STUCK TO. HE SAID HE CAN ONLY ASSUME IT IS STUCK THERE EVEN BEFORE HE POPS THE STERILE WATER PACKET. HE HAS TO PULL REALLY HARD TO GET IT OUT AND THIS PROCESS IS NOT SMOOTH AT ALL HE SAID. OFTEN CATHETER WILL RELEASE WITH A SHARP EDGE HE THINKS IS FROM FROM THE COATING/GLUE. HE TRIES TO SMOOTH OUT THE SHARP EDGES WITH PRESSURE. HE CAN FEEL THE SHARP EDGE TO SMOOTH BY THE STUCK PART WHILE IT IS STILL IN THE PACKAGING SO IT DOESN'T BECOME UNSTERILE PRIOR TO USE. HE STARTED DOING THIS BECAUSE ONCE HE DID GET CUT BY USING A CATHETER WITH THIS SHARP EDGE AND HE HAS A LITTLE BIT OF BLEEDING HE SAID THAT LASTED FOR ABOUT 2 CATHS. NO MEDICAL INTERVENTION SOUGHT. HE STATES HE DOES NOT HAVE PAIN WITH USE OF THESE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15320342 ↗