Artemis AP21-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548017860), received between Mar 12, 2019 and Mar 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT BASAL GANGLIA USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, THE PHYSICIAN USED THE ARTEMIS FOR APPROXIMATELY ONE HOUR. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE USING THE ARTEMIS TO ASPIRATE A DENSE THROMBUS. THE PENUMBRA SALES REPRESENTATIVE THEN VIEWED THE ENDOSCOPE MONITOR AND NOTICED THAT THE BIDENT WAS STICKING OUT FROM THE TIP OF THE ARTEMIS HYPOTUBE. HOWEVER, IT WAS NOTED THAT THE BIDENT WAS STILL ABLE TO ROTATE. THE ARTEMIS WAS THEN REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413024 ↗