Excelsior SL-10 M0031681910Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540688231), received between Dec 6, 2016 and May 24, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT CATHETER PTFE (POLYTETRAFLUOROETHYLENE) 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 19397729 ↗
• MalfunctionDec 14, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE CATHETER SHAFT (SUBJECT DEVICE) WAS BLOCKED WITH PTFE (POLYTETRAFLUOROETHYLENE) LINING FROM THE CATHETER. 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 18327425 ↗
• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A STROKE PROCEDURE THE SUBJECT MICROCATHETER BROKE SPONTANEOUSLY INTO TWO PIECES AT THE JUNCTION OF THE RHV AND 3-WAY, SO INSIDE THE FLUSHING SYSTEM. THE SUBJECT DEVICE WAS REMOVED AND REPLACED. THERE WAS A SURGICAL DELAY BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781007 ↗
• MalfunctionOct 13, 2022Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT MICROCATHETER PTFE (POLYTETRAFLUOROETHYLENE)COATING WAS PEELING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15593054 ↗
• InjuryJan 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE COILING PROCEDURE FOR THE RIGHT PERI CAVERNOUS DURAL ARTERIOVENOUS FISTULA, THE DISTAL FLUORO SAVER MARKER ON THE SUBJECT MICROCATHETER WAS DETACHED INSIDE THE PATIENT'S ANATOMY. THE DETACHED FLUORO SAVER MARKER WAS LEFT INSIDE THE PATIENT ¿S VENOUS CHANNEL WITHIN THE RIGHT PETROUS BONE AND WAS STABLE IN POSITION. THE PATIENT¿S CURRENT CONDITION WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT IMPACT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13365801 ↗
• MalfunctionOct 7, 2020Misassembled; Misassembled

  DURING IC-PC (INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY) RUPTURED ANEURYSM PROCEDURE AFTER ALIGNMENT OF COIL DETACH MARKER WITH THE INVERTED T BEYOND THE PROXIMAL MARKER OF MICROCATHETER (SUBJECT DEVICE), THE COIL COULD NOT BE REMOVED OUT OF THE MICROCATHETER FOR DETACHMENT BECAUSE THE COIL REMAINED IN THE CATHETER TIP. THE COIL WAS REMOVED, AND A NEW COIL WAS INSERTED. THE SUBJECT CATHETER MARKERS WERE ALIGNED IN THE SAME WAY, BUT THE SECOND COIL ALSO COULD NOT BE REMOVED OUT OF THE MICROCATHETER. THERE WAS MORE THAN 3 CM BETWEEN THE TIP MARKER AND THE PROXIMAL MARKER OF THE MICROCATHETER. 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 10646146 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT SUB ARACHNOID HEMORRHAGE DUE TO ANEURYSM RUPTURE, TWO COILS WERE SUCCESSFULLY PLACED IN THE ANEURYSM. WHEN THE THIRD COIL USED, IT STUCK AT THE DISTAL TIP OF THE SUBJECT CATHETER. WHEN ATTEMPTING TO DISLODGE STUCK COIL, ANEURYSM RE-RUPTURED DUE TO MICROWIRE PIERCING THE ANEURYSM DOME. ONCE THE COIL WAS DISLODGED, PHYSICIAN TREATED RUPTURED ANEURYSM WITH SUBJECT CATHETER AND ADDITIONAL COILING. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT SCORED A 15 ON THE GSC (GLASGOW COMA SCALE) AND WAS MOVING ALL LIMBS

  Patient problems: Aneurysm; Rupture; Ruptured Aneurysm

  MAUDE report 10365485 ↗
• MalfunctionMay 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER (SUBJECT DEVICE) BROKE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080825 ↗
• MalfunctionFeb 12, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MICROCATHETER TIP WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333603 ↗
• MalfunctionNov 21, 2017Break; Break

  ANALYSIS OF THE RETURNED MICROCATHETER (SUBJECT DEVICE) FOUND THAT IT WAS BROKEN AT APPROXIMATELY 131CM FROM THE HUB AND AT THE DISTAL TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7051381 ↗
• InjuryJul 13, 2017Break; Break

  DURING THE PROCEDURE THE RADIOGRAPHY WAS NOT SUCCESSFUL, SO THE PHYSICIAN CHECKED CAREFULLY AND FOUND THAT THE DISTAL SECTION OF THE MICROCATHETER (SUBJECT DEVICE) WAS BROKEN. THE PHYSICIAN THEN WITHDREW THE MICROCATHETER AND THE GUIDEWIRE TOGETHER, AND THE GUIDEWIRE WAS ALSO FOUND TO BE BROKEN. THE BROKEN PART OF THE GUIDEWIRE AND MICROCATHETER WERE SNARED FROM THE VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CHANGING THE DEVICES. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711505 ↗
• MalfunctionDec 6, 2016Leak/Splash; Leak/Splash

  UPON REMOVAL OF THE SUBJECT DEVICE FROM THE PATIENT¿S BODY, THE PHYSICIAN OBSERVED SALINE LEAKING NEAR THE STRAIN RELIEF OF THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149034 ↗