Excelsior XT-17 Flex M003C1715ST0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252714903), received between Nov 4, 2022 and Jun 5, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Fracture

  IT WAS REPORTED THAT WHEN THE COIL REACHED A POSITION APPROXIMATELY 4MM FROM THE MARKER AT THE TIP OF THE SUBJECT MICROCATHETER, THE PHYSICIAN FOUND THAT THE COIL HAD ALREADY PUSHED OUT OF THE TIP OF THE SUBJECT MICROCATHETER. THE PHYSICIAN THEN WITHDREW THE SUBJECT MICROCATHETER AND FOUND THAT THE TIP OF THE MICROCATHETER WAS BROKEN. THE SUBJECT DEVICE WAS REPLACED, AND 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 25411074 ↗
• MalfunctionMay 2, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE SECOND MARKER ON THE DISTAL END OF THE MICROCATHETER (SUBJECT DEVICE) HAD SEPARATED AND DETACHED FROM THE MICROCATHETER SHAFT WHEN THE MICROCATHETER WAS UNPACKED. THE SUBJECT DEVICE WAS REPLACED, AND 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 21953451 ↗
• MalfunctionApr 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE LEFT MIDDLE CAROTID ARTERY (MCA) PROCEDURE, THE OPERATOR DELIVERED A SUBJECT MICROCATHETER TO THE DESIGNATED POSITION AND THEN DELIVERED A STENT THROUGH THE SUBJECT MICROCATHETER. WHEN THE STENT WAS APPROXIMATELY 5CM FROM THE TIP OF THE SUBJECT MICROCATHETER, THE OPERATOR NOTICED THAT THE MARKER AT THE STENT'S DISTAL END HAD OPENED. SUBSEQUENTLY, THE MICROCATHETER AND STENT WERE WITHDRAWN TOGETHER. UPON WITHDRAWAL, IT WAS FOUND THAT THE SUBJECT MICROCATHETER HAD BROKEN APPROXIMATELY 5CM FROM ITS TIP, WHICH WAS THE LOCATION WHERE THE STENT'S DISTAL END HAD OPENED. AFTER OBSERVING THAT THE PATIENT'S BLOOD FLOW WAS MAINTAINED, THE PHYSICIAN CONCLUDED THE SURGERY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21850595 ↗
• MalfunctionJan 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A M2 BIFURCATION ANEURYSM CASE, SUBJECT MICROCATHETER WAS USED TO DEPLOY A STENT. WHILE DOING SO, THE OPERATOR CHECKED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND FOUND THE SUBJECT MICROCATHETER MIGRATED DOWNWARD THE ANEURYSM AND COULD NOT BE DELIVERED TO THE LOCATION ANYMORE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SHAFT OF THE SUBJECT MICROCATHETER WAS FOUND TO BE BROKEN/FRACTURED DURING USE. 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 18474904 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING STENT IMPLANTATION ANEURYSM EMBOLIZATION CASE, A BIG RESISTANCE WAS ENCOUNTERED WHEN DELIVERING THE STENT THROUGH THE MICROCATHETER (SUBJECT DEVICE) AND THE STENT WAS HARD TO BE ADVANCED. FINALLY, WHEN IT REACHED TO THE TIP OF THE SUBJECT MICROCATHETER, THE RESISTANCE BECAME BIGGER AND ONLY THE TIP OF THE STENT COULD BE DEPLOYED. THEREFORE, THE STENT AND THE SUBJECT MICROCATHETER WERE WITHDRAWN TOGETHER. IT WAS OBSERVED THAT THE SEGMENT AT THE SUBJECT MICROCATHETER NEAR THE TAIL OF THE STENT WAS FRACTURED. THE STENT AND SUBJECT MICROCATHETER WERE REPLACED WITH OTHER PRODUCTS TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448923 ↗
• MalfunctionNov 10, 2022Fracture; Fracture

  PRIOR PROCEDURE, THE PATIENT PRESENTED WITH SUBARACHNOID HEMORRHAGE (SAH) AND ACOMA ANEURYSM. THE GUIDEWIRE WAS USED TO DELIVER THE ECHELON-10 MICROCATHETER TO THE ANEURYSM AND THEN FILLED WITH COILS. WHEN DELIVERING THE STENT INTO THE SUBJECT MICROCATHETER, THE RESISTANCE WAS ENCOUNTERED AND THE CATHETER SHAFT (SUBJECT DEVICE) NEAR THE HUB WAS FRACTURED WHEN DELIVERED WITH FORCE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15772740 ↗
• MalfunctionNov 4, 2022Material Puncture/Hole; Material Puncture/Hole

  THE MICROCATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT DEVICE SHAFT HAD A HOLE/PERFORATION. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740157 ↗