UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1 (UDI 04953170355639)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170355639), received between Oct 31, 2022 and Jan 22, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Poor Quality Image” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT WHILE UNDER SEDATION FOR A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, THE ULTRASOUND IMAGE QUALITY WAS POOR. THE ISSUE OCCURRED MID-PROCEDURE CAUSING A SURGICAL PROLONGATION GREATER THAN 30 MINUTES. THE ISSUE WAS RESOLVED AFTER UTILIZATION OF A NEW SCOPE AND BALLOON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213490 ↗
• InjuryJan 22, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT WHILE UNDER SEDATION FOR A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, THE ULTRASOUND IMAGE QUALITY WAS POOR. THE ISSUE OCCURRED MID-PROCEDURE CAUSING A SURGICAL PROLONGATION GREATER THAN 30 MINUTES. THE ISSUE WAS RESOLVED AFTER UTILIZATION OF A NEW SCOPE AND BALLOON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211846 ↗
• MalfunctionOct 31, 2022Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  IT WAS REPORTED THE DEVICE PROCESSOR CRASHED FOUR (4) TIMES (SCREEN BLACKED OUT) WHEN USER HAD A NEEDLE IN A PATIENTS NODE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE. ACCORDING TO THE REPORT, THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. NO DELAY IN THE PROCEDURE WAS REPORTED. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704324 ↗