Medline DYND160718Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389235140), received between Nov 26, 2019 and Sep 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 8, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672744 ↗
• MalfunctionNov 26, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER BURST RESULTING IN THE FOLEY CATHETER FALLING FROM BEING INSERTED IN PATIENT. PATIENT REQUIRED ANOTHER FOLEY CATHETER INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375961 ↗