ENCOR ULTRA® E5115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741086137), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 malfunction.

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

• MalfunctionApr 23, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT SAMPLING WAS CONDUCTED WITHOUT PUSHING SAMPLE BUTTON. REPLACED A PROBE WITH ANOTHER, AND PROCEDURE WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING SAMPLING. WHEN THE OPENER WAS CLOSED, DISCONNECTED THE NEEDLE AND REPLACED WITH ANOTHER NEEDLE. THEN PROCEDURE WAS COMPLETED. NO ERROR MESSAGES WERE DISPLAYED. A PATIENT WAS INVOLVED, HOWEVER THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888163 ↗