Excelsior SL-10 M0031681810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540688200), received between Jun 21, 2019 and Mar 19, 2025 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644335 ↗
• MalfunctionNov 20, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT CATHETER (SUBJECT DEVICE) PTFE INNER LINING WAS IDENTIFIED IN THE SHAFT. 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 20735713 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PROCEDURE OF THROMBECTOMY FOR LEFT M1-DISTAL WAS PERFORMED ON (B)(6) 2020. THE MODIFIED RANKIN SCALE (MRS) OF THE PATIENT BEFORE THE PROCEDURE WAS 2. THE ALBERTA STROKE PROGRAM EARLY CT SCORE (ASPECTS) BEFORE PROCEDURE WAS 8. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) WAS 0 BEFORE PROCEDURE. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE BEFORE THE PROCEDURE WAS 26. A RETRIEVER AND ASPIRATION CATHETER WERE USED TO COMPLETE THE 1ST AND 2ND PASSES. HOWEVER, THE MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) WAS NOT IMPROVED AND REMAINED 0 AFTER THE 2ND PASS. 3RD PASS WAS PERFORMED USING A MICROCATHETER (SUBJECT DEVICE), STENT RETRIEVER AND A GUIDEWIRE. VESSEL PERFORATION OCCURRED DURING THE 3RD PASS; HOWEVER, THE PHYSICIAN COULD NOT IDENTIFY WHICH DEVICE CAUSED THE PERFORATION. AFTER THE PROCEDURE, THE FINAL TICI WAS 2A AND NIHSS WAS 30. THE MRS SCORE BECAME WORSE TO 4 ON (B)(6) 2020 AND THE MRS SCORE BECAME WORSE TO 5 ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 11445808 ↗
• MalfunctionJun 21, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN A SURGEON WAS REMOVING A MANDREL FROM THE SUBJECT DEVICE MICROCATHETER, THE RESISTANCE WAS FELT AND NOTICED THAT THE COATING WAS PEELING. ANOTHER NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724071 ↗