Self-Cath 50468 / 614Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932999441), received between Feb 20, 2018 and Feb 21, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Positioning Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT COMPLAINT REGARDING ITEM# 614 - LOT# 5607497 AND 5865261. THE PATIENT STATED THAT THE CATHETERS ARE CAUSING HIM TO BLEED. THE PATIENT STATED THAT HOSPITALIZATION WAS REQUIRED. THE CATHETERS MAY HAVE BEEN NICKING A BLOOD VESSEL IN THE PROSTATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7285652 ↗
• InjuryFeb 20, 2018Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT COMPLAINED REGARDING ITEM# (B)(4)- LOT# 5607497 AND 5865261. THE PATIENT STATED THAT THE CATHETERS ARE CAUSING HIM TO BLEED. THE PATIENT STATED THAT HOSPITALIZATION WAS REQUIRED. THE CATHETERS MAY HAVE BEEN NICKING A BLOOD VESSEL IN THE PROSTATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7284235 ↗