Excelsior SL-10 M0031681920Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540688248), received between Aug 6, 2018 and Sep 10, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714424 ↗
• MalfunctionApr 13, 2026Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866000 ↗
• MalfunctionApr 22, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE GUIDEWIRE ENCOUNTERED STRONG RESISTANCE WHEN ADVANCED INTO THE SUBJECT CATHETER HUB. THE PHYSICIAN FOUND OUT THE SUBJECT CATHETER INNER LUMEN HAS SOME PROBLEM (THE COATING IS DAMAGED). 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 21878817 ↗
• MalfunctionOct 20, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SUBJECT MICROCATHETER WAS INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION DURING/AFTER UNPACKING AS DESCRIBED IN DEVICE DIRECTIONS FOR USE (DFU). AFTER THE SUBJECT MICROCATHETER WAS PLACED IN THE PATIENT, ADVANCE ALONG VESSEL COULD NOT BE FOLLOWED ON THE ANGIOGRAPHY DEVICE. THE PHYSICIAN THINKS MICROCATHETER HAS NO MARKER. THEREFORE, THE SUBJECT MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668796 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE WAS RUPTURED C2-3 ANEURYSM STENT ASSISTED COIL EMBOLIZATION, THE STENT WAS DEPLOYED WITHOUT ANY PROBLEMS. THE STENT DELIVERY WIRE (SDW) WAS ATTEMPTED TO BE WITHDRAWN BUT THE SDW AND THE STENT GOT STUCK EACH OTHER. THE MICROCATHETER (SUBJECT DEVICE) WAS ADVANCED TO RELEASE THE STICKING, BUT IT ALSO STUCK WITH THE SDW. THE HUB OF THE MICROCATHETER WAS CUT OFF AND SNARE DEVICE WAS NAVIGATED TO THE SDW VIA THE MICROCATHETER OUTER SHAFT. THE SNARE DEVICE CAUGHT THE SDW, THEN THE SDW AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT WHILE INVOLVING A SLIGHT STENT DISPLACEMENT. THE REMOVED SDW TIP WAS FOUND STRETCHED AND SEPARATED. COILING WAS STARTED, BUT A DISTAL BLOOD FLOW OF THE ANEURYSM CAME NOT TO BE SHOWN IN ANGIOGRAPHY DURING COILING. CROSS FLOW FROM OPPOSITE SIDE WAS SUFFICIENT, SO THE PROCEDURE WAS FINISHED WITHOUT RECANALIZATION OF THE DISTAL BLOOD FLOW. THE PATIENT'S CONDITION IS BRAIN DEATH DUE TO THE PREEXISTING SUB ARACHNOID HEMORRHAGE WORSENING.

  Patient problems: Thrombosis

  MAUDE report 7754655 ↗