Excelsior SL-10 M0031681890Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 04546540688217), received between May 9, 2016 and Sep 30, 2026 — classified as 2 deaths, 20 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (76 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 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948924 ↗
• MalfunctionSep 25, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906143 ↗
• MalfunctionSep 22, 2026Peeled/Delaminated

  It was initially reported that during PComA aneurysm coil embolization procedure, when the stent was advancing through the subject microcatheter, the stent got stuck in the middle of the subject microcatheter. The physician withdrew the stent together with the subject microcatheter out of the body, switched to a different brand of microcatheter and stent, and the procedure was successfully completed. The subject catheter was returned for analysis and examined. The returned catheter showed peeling of its Polytetrafluoroethylene (PTFE) inner lining during investigation. No clinical consequences to the patient were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850070 ↗
• MalfunctionAug 18, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302415 ↗
• MalfunctionAug 17, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286351 ↗
• MalfunctionAug 7, 2026Peeled/Delaminated

  The subject microcatheter was returned for analysis and the device investigation revealed that Polytetrafluoroethylene (PTFE) lining was peeled. No clinical consequences were reported to the patient due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184529 ↗
• MalfunctionJun 5, 2026Peeled/Delaminated

  THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THERE WAS AN UNKNOWN MATERIAL PRESENT ON THE STENT AND POSSIBLY IT MIGHT BE SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE) FROM THE SUBJECT MICROCATHETER. 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 25408965 ↗
• MalfunctionMay 20, 2026Insufficient Device Problem Information

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. 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 25234401 ↗
• MalfunctionMay 8, 2026Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. 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 25124384 ↗
• MalfunctionMay 8, 2026Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. 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 25120132 ↗
• MalfunctionApr 30, 2026Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. 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 25047136 ↗
• MalfunctionApr 14, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE STENTS WOULD NOT GO THROUGH THE SUBJECT MICROCATHETER. THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT CATHETER HAD PTFE INNER LINING PEELING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873240 ↗
• MalfunctionApr 13, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANEURYSM PROCEDURE, THE PHYSICIAN ENCOUNTERED INCREASED RESISTANCE WHEN THE GUIDEWIRE REACHED THE MID-SECTION OF THE SUBJECT MICROCATHETER. HOWEVER, THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT CATHETER HAD PTFE INNER LINING PEELING. 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 24866249 ↗
• MalfunctionMar 30, 2026Material Puncture/Hole

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE DISTAL SHAFT OF CATHETER HAS A HOLE/PERFORATION. THE CATHETER WAS DIFFICULT TO FLUSH AND RESISTANCE WAS NOTED WITHIN THE SHAFT OF CATHETER. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED AND PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710232 ↗
• MalfunctionMar 19, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED BY THE STENT AT THE PROXIMAL PART OF THE SUBJECT MICROCATHETER WHILE ADVANCING THE STENT INTO IT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING OF THE SUBJECT MICROCATHETER WAS PEELED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646248 ↗
• MalfunctionMar 19, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT STENT THROUGH THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING OF THE SUBJECT CATHETER WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646228 ↗
• MalfunctionMar 4, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE FOR AN INTRACRANIAL ANEURYSM, WHEN THE STENT WAS BEING DELIVERED INTO THE HUB OF THE SUBJECT MICROCATHETER, EXCESSIVE RESISTANCE WAS ENCOUNTERED, PREVENTING NORMAL INTRODUCTION. HOWEVER, THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS, AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER HAD PTFE INNER LINING PEELING. 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 24513781 ↗
• MalfunctionFeb 19, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE CATHETER SUBJECT DEVICE WAS USED IN THE MEDICAL PROCEDURE. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS OBSERVED THAT THE CATHETER SHAFT HAD FRICTION AND THE SHAFT WAS KINKED/BENT. ALSO, THE INNER POLY TETRA FLUORO ETHYLENE (PTFE) LINING WAS PEELING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385459 ↗
• MalfunctionFeb 18, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE SUBJECT CATHETER ENCOUNTERED SIGNIFICANT RESISTANCE DURING THE PROCESS OF ADVANCING THE STENT INTO THE MICROCATHETER. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN FINALLY MANAGED TO INTRODUCE THE STENT INTO THE SUBJECT MICROCATHETER, BUT THE RESISTANCE PERSISTED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE INNER POLYTETRAFLUOROETHYLENE (PTFE) LINING OF THE SUBJECT MICROCATHETER WAS PEELED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384928 ↗
• MalfunctionJan 29, 2026Material Puncture/Hole

  ANALYSIS OF THE RETURNED SUBJECT DEVICE (MICROCATHETER) REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED PIERCING THE DISTAL SHAFT OF THE MICROCATHETER THROUGH A HOLE. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211114 ↗
• MalfunctionJan 29, 2026Peeled/Delaminated

  THE CATHETER SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE PTFE) PRESENT ON THE DISTAL END OF THE STENT. 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 24206759 ↗
• MalfunctionJan 16, 2026Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE INNER LINING PEELING. 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 24090925 ↗
• MalfunctionDec 17, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE MIDDLE CEREBRAL ARTERIES (MCA) ANEURYSM PROCEDURE, AFTER THE ACCESS WAS ESTABLISHED, THE PHYSICIAN SELECTED GUIDEWIRE AND SUBJECT MICROCATHETER FOR DELIVERY TO THE TARGET SITE. UPON REACHING THE LESION SITE, THE PHYSICIAN FOUND THAT THE GUIDEWIRE WAS STUCK INSIDE THE SUBJECT MICROCATHETER. THE PHYSICIAN GENTLY WITHDREW BOTH THE MICROCATHETER AND THE GUIDEWIRE TOGETHER OUT OF THE BODY FOR INSPECTION. WHEN WITHDRAWING THE GUIDEWIRE FROM THE SUBJECT MICROCATHETER ON THE OPERATING TABLE, IT WAS FOUND THAT THE INNER COATING OF THE MICROCATHETER HAD PEELED OFF. 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 23834902 ↗
• MalfunctionDec 17, 2025Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) PTFE COATING WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832682 ↗
• MalfunctionDec 17, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE INNER POUCH OF THE CATHETER (SUBJECT DEVICE) WAS NOT SEALED WHEN THE PHYSICIAN OPENED THE OUTER PACKAGING. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825142 ↗