Areus(TM) Endobronchial Ultrasound Aspiration Needle EBUS00001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06932503549219), received between Jan 20, 2026 and Sep 21, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Display or Visual Feedback Problem

  It is reported during endobronchial ultrasound case, endobronchial ultrasound scope (b)(6) broke related to thoracent/areus endobronchial ultrasound aspiration needle.Scope working at beginning of case. Passed needle through channel, scope still working. Attempted to deploy needle and image on screen became pixelated. Removed needle and attempted to reinsert/redeploy, and pixelation on screen became worse. Pixelation on screen became worse with every attempt to redeploy needle.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835423 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT "NEEDLE CAME THROUGH SHEATH- REMOVED FROM FIELD AND REPLACED WITH NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112405 ↗