EXCELSIOR XT-27 Flex M003XT2750920Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540698162), received between Apr 12, 2017 and Dec 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• MalfunctionDec 14, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE TREATMENT OF A CEREBRAL ANEURYSM PROCEDURE, WHILE ADVANCING THE FLOW DIVERTER INSIDE THE SUBJECT MICROCATHETER THE PHYSICIAN FOUND A HOLE/ PERFORATION IN THE TRANSITION BETWEEN THE HYDROPHILIC AND PROXIMAL PARTS OF THE SUBJECT MICROCATHETER. THE FLOW DIVERTER WAS COMING OUT OF THE PERFORATION IN THE SUBJECT MICROCATHETER INSTEAD OF THE DISTAL LUMEN. 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 13006377 ↗
• MalfunctionDec 16, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT MICRO CATHETER OPENED IN THE TRANSITION BETWEEN THE HYDROPHILIC PART AND THE PROXIMAL PART WHEN ADVANCING THE FLOW DIVERSION. THE FLOW DIVERSION PARTIALLY EXITED THROUGH THIS OPENING AND NOT THROUGH THE NATURAL LUMEN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015355 ↗
• MalfunctionApr 12, 2017Break; Break

  IT WAS REPORTED THAT THE SUBJECT MICROCATHETER WAS NAVIGATED SUCCESSFULLY TO THE LEFT PCA. WHEN THE PHYSICIAN STARTED TO ADVANCE A STENT IN THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN NOTED THAT THE MICROCATHETER WAS BROKEN. THE MICROCATHETER AND STENT WHERE REMOVED OUT OF THE PATIENT THROUGH THE GUIDE CATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6487817 ↗