Medline URO170806Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942738588), received between May 2, 2024 and Sep 17, 2026 — classified as 1 injury, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 17, 2026Detachment of Device or Device Component

  It was reported that "Detached Sample Port."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803986 ↗
• InjuryMay 2, 2024Break; Break

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE SAMPLE PORT "DISCONNECTED" WHEN THE CLINICIAN WAS "ATTEMPTING TO DRAW A SAMPLE WITH A SYRINGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227189 ↗