Self-Cath 50453 / 414Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932576307), received between Dec 10, 2015 and Jun 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES AN EVENT WHERE AN END-USER (FEMALE) OF UNKNOWN AGE WAS HARMED. THE COMPLAINT IS FILED BY THE END-USER¿S FAMILY, AS THE END-USER HERSELF IS A MINOR. THE EVENT IS DESCRIBED AS THE CATHETER BREAKING AND LEAVING THE TIP INSIDE THE END-USER¿S BODY AND TWO SURGERIES WERE NEEDED TO REMOVE THE TIP. THE END-USER WAS FINALLY DISCHARGED THE 2ND OF JUNE. THE FIRST SURGERY REQUIRED 1 OVERNIGHT STAY AT THE HOSPITAL, AND THE SECOND A 2-NIGHT STAY. IT IS UNCLEAR WHAT TYPE OF SURGERY WAS PERFORMED, WHY THE SECOND ONE WAS NEEDED, AND WHAT HARM WAS CAUSED. THE REASON FOR THE CATHETER BREAKING IS NOT KNOWN, THERE ARE NO INDICATIONS OF THE PRODUCT BEING FAULTY, AND IT IS UNKNOWN WHETHER THE PRODUCT WAS USED ACCORDING TO THE INSTRUCTION FOR USE. THE REASON FOR NEEDING INTERMITTENT CATHETERISATION AND THE FAMILY¿S EXPERIENCE WITH INTERMITTENT CATHETERS IS NOT STATED. ALSO, THE REASON FOR THE FEMALE END-USER USING A MALE-CATHETERS IS NOT CLEAR. CHILD PROTECTIVE SERVICE IS STATED TO BE INVOLVED, BUT NOT FOR WHAT REASON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Tissue Breakdown

  MAUDE report 14744221 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem

  THIS CASE INVOLVES A MALE END USER (EU) WHO HAS BEEN CATHETERIZING FOR YEARS. OVER THE LAST 5 OR SO MONTHS HIS PROSTATE HAS ENLARGED AND HE HAS NOTICED BLEEDING DURING CATHETERIZATION. THIS BLEEDING STARTED OUT AS MAYBE A 1/2 INCH SMEAR OF BLOOD ON HIS CATHETER TO NOW QUITE A BIT MORE. EVENTUALLY THE BLOOD WAS OBSERVED IN HIS BLADDER FOR WHICH HE UNDERWENT AN ABLATION SURGICAL PROCEDURE TO HELP EASE THE CATHETERIZATION PROCESS. THE EU WAS DISCHARGED ON (B)(6) 2021 AND CURRENTLY HAS A FOLEY CATHETER IN. HIS DOCTOR HAS RECOMMENDED THE USE OF SOFTER CATHETERS WITH A COUDE TIP FOR FUTURE CATHETERIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematuria; Perforation of Vessels

  MAUDE report 12009635 ↗
• InjuryDec 10, 2015Device Operates Differently Than Expected; Material Integrity Problem

  PATIENT STATED THE EYELETS ARE ROUGH TO THE TOUCH AND SCRATCHED HIS URETHRA. HE WENT TO THE DOCTOR AND HE SAYS THEY PRESCRIBED ANTIBIOTICS, WHICH HELPED. NO SERIOUS INJURY OR BLEEDING.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 5286879 ↗