Excelsior 1018 M0031441810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540688118), received between Dec 22, 2022 and Feb 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionFeb 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE MICROCATHETER (SUBJECT DEVICE) WAS PLACED IN THE EXTERNAL CAROTID ARTERY AND THE IMAGING WAS CONFIRMED, A CONTRAST AGENT WAS FOUND TO BE LEAKING APPROXIMATELY 5 CM FROM THE TIP OF THE MICROCATHETER (SUBJECT DEVICE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278006 ↗
• MalfunctionDec 22, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, THE RADIO OPAQUE DISTAL MARKER OF THE SUBJECT MICROCATHETER WAS NOT VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16031881 ↗