EXCELSIOR XT-27 M003XT2735810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540698094), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 19, 2022Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE RETREATMENT OF RECANALIZATION/RESIDUAL FOR A PREVIOUSLY TREATED ANEURYSM FRICTION WAS FELT WHILE ADVANCING THE STENT INSIDE THE SUBJECT MICROCATHETER BUT THE STENT WAS DEPLOYED AND THE DISTAL TIP OF THE SUBJECT MICROCATHETER WAS ALSO DAMAGED. THE PATIENT SUFFERED SUBARACHNOID BLEEDING AND LENTICULOSTRIATE ARTERY PERFORATION WHICH WAS ALLEGED TO BE CAUSED BY THE SUBJECT MICROCATHETER . THERE WAS NO TREATMENT PERFORMED TO RESOLVED THE ADVERSE EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 14147658 ↗