MEDLINE DYND19120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196993819), received between Apr 24, 2026 and Sep 22, 2026 — classified as 3 malfunctions.

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

• MalfunctionSep 22, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856755 ↗
• MalfunctionSep 8, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670182 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  CUSTOMER REPORTED, "IRRIGATION SET IS LEAKING AND IS HARD TO SNAP INTO THE FLUID AND LEAKS AS A RESULT."

  Patient problems: Insufficient Information

  MAUDE report 24984234 ↗