Medline DYND11090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196991440), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SYRINGE COMPONENT IS DETACHING FROM THE FOLEY CATHETER INFLATION VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825628 ↗