Excelsior SL-10 M0031681900Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04546540688224), received between Jul 25, 2016 and May 19, 2026 — classified as 10 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (16 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Peeled/Delaminated

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT DEVICE PTFE (POLYTETRAFLUOROETHYLENE) INNER LINING WAS REMOVED (PEELED) DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212381 ↗
• MalfunctionMar 4, 2026Material Puncture/Hole; Insufficient Device Problem Information

  THE SUBJECT CATHETER WAS RETURNED, AND INITIAL INSPECTION REVEALED A HOLE/PERFORATION IN THE CATHETER SHAFT. FURTHER INVESTIGATION IS STILL PENDING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505456 ↗
• MalfunctionFeb 19, 2026Peeled/Delaminated

  IT WAS REPORTED THAT SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT THROUGH THE SUBJECT MICROCATHETER. THE STENT BECAME COMPLETELY IMMOBILE AFTER APPROXIMATELY 15MM HAD ENTERED THE SUBJECT MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT BACK INTO THE INTRODUCING SHEATH BUT ALSO ENCOUNTERED SUBSTANTIAL RESISTANCE. THE PHYSICIAN THEN REPLACED IT WITH ANOTHER STENT OF THE SAME, WHICH ENCOUNTERED THE SAME ISSUE WHEN ENTERING THE SAME SUBJECT MICROCATHETER. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE SECOND STENT BACK OUT OF THE BODY, THE SECOND STENT BECAME DETACHED FROM THE DELIVERY WIRE, LEAVING THE STENT INSIDE THE PROXIMAL END OF 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. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE INNER LINING OF POLYTETRAFLUOROETHYLENE (PTFE) WAS FOUND TO BE PEELED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397039 ↗
• InjuryFeb 10, 2026Fracture

  IT WAS REPORTED THAT DURING STENT ASSISTED COIL EMBOLIZATION PROCEDURE, THE SUBJECT MICROCATHETER WAS USED TO DELIVER A STENT. DURING THE PROCESS OF RETRACTION AND RELEASING TENSION OF THE SUBJECT MICROCATHETER, THE MARKER RING OF THE SUBJECT MICROCATHETER GOT FRACTURED AND REMAINED WITHIN THE INTRACRANIAL VESSEL OF THE PATIENT. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304740 ↗
• MalfunctionNov 24, 2025Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (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 23633529 ↗
• MalfunctionOct 31, 2025Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT MICROCATHETER HAD PTFE INNER LINER 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 23441937 ↗
• MalfunctionOct 21, 2025Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE CATHETER PTFE (POLYTETRAFLUOROETHYLENE) INNER LINING WAS 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 23349501 ↗
• MalfunctionJul 25, 2025Material Puncture/Hole; Material Puncture/Hole

  THE MICROCATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SHAFT OF THE SUBJECT DEVICE HAD A HOLE AND WAS DAMAGED. ALSO, THE TIP OF THE SUBJECT DEVICE WAS FOUND TO BE 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 22610556 ↗
• MalfunctionJul 10, 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 22469797 ↗
• MalfunctionMay 2, 2025Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER TIP WAS BROKEN/FRACTURED DURING USE AND RO MARKER(S) WERE DETACHED/SEPARATED/NOT VISIBLE UNDER FLUOROSCOPY. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947487 ↗
• MalfunctionFeb 20, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE CATHETER PTFE (POLYTETRAFLUOROETHYLENE) LINING WRAPPED AROUND THE STRUTS. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418326 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098297 ↗
• MalfunctionOct 24, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS FOUND THAT THE (PTFE) POLYTETRAFLUOROETHYLENE INNER LINING HAD PEELED DURING USE. 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 20522907 ↗
• MalfunctionOct 23, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE CATHETER (SUBJECT DEVICE) PTFE (POLYTETRAFLUOROETHYLENE) 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 20517619 ↗
• MalfunctionOct 8, 2024

  PER REPORT: DISTAL PORTION OF THE CATHETER WAS LEFT IN THE PATIENT POST-PROCEDURE. EXCERPTS FROM OPERATIVE REPORT: IT WAS DETERMINED THAT THE SL-10 WAS IN OPTIMAL POSITION FOR EMBOLIZATION OF THE RIGHT MMA [MIDDLE MENINGEAL ARTERY]. NEXT AN NBCA [N-BUTYL 2-CYANOACRYLATE] KIT (TRUFILL/J&J) WAS OPEN AND PREPARED OUTSIDE THE BODY IN THE USUAL FASHION WITH A NBCA GLUE DILUTION OF 1:3 WITH LIPIODOL AND TANTALUM POWDER. THE SL-10 MICROCATHETER WAS PRIMED WITH D5W PRIOR. APPROXIMATELY 1 CC OF NBCA GLUE DILUTION WAS INTRODUCED AND INJECTED THROUGH THE SL-10 INTO THE RIGHT MMA DISTALLY. THE RIGHT MMA WAS IMMEDIATELY EMBOLIZED. THEN THE SL-10 CATHETER WAS ATTEMPTED TO BE RETRIEVED BACK, BUT IT WAS DETERMINED THAT THE DISTAL END IF THE CATHETER WAS ATTACHED TO THE RIGHT MMA ALSO. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SL-10, BUT THE DISTAL PORTION OF THE CATHETER DETACHED. THE REMAINDER OF THE CATHETER WAS ABLE TO BE REMOVED FROM THE CIRCULATION AND FROM THE BODY IN ITS ENTIRETY. A GOOSE NECK SNARE WAS ATTEMPTED TO GRAB THE REMAINDER OF THE CATHETER, BUT THAT WAS UNSUCCESSFUL. AFTER FURTHER REVIEW (SECONDARY OPINION PROVIDED BY ANOTHER MD), IT WAS DETERMINED THAT THE PATIENT WOULD LIKELY

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20395766 ↗
• MalfunctionFeb 29, 2024Peeled/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. 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 18813340 ↗
• MalfunctionFeb 19, 2024Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) SHAFT BROKEN/FRACTURED DURING USE, THE CATHETER POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING PEELING, RADIOPAQUE (RO) MARKER(S) DETACHED/SEPARATED/NOT VISIBLE UNDER FLUOROSCOPY. 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 18735649 ↗
• MalfunctionOct 11, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING THE MICROCATHETER (SUBJECT DEVICE) THERE WAS NO DISTAL RADIOPAQUE MARKER PRESENT ON THE MICROCATHETER (SUBJECT DEVICE). 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 17916162 ↗
• MalfunctionFeb 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN INSERTING A COIL INTO THE SUBJECT MICROCATHETER AND IT WAS DISCOVERED THAT THE DISTAL TIP OF THE MICROCATHETER WAS BROKEN. 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 16293130 ↗
• MalfunctionSep 7, 2022Fracture; Fracture

  DURING AN ANEURYSM EMBOLIZATION PROCEDURE, TWO COILS WERE SUCCESSFULLY INSERTED INTO THE SUBJECT MICROCATHETER. WHEN ATTEMPTED TO INSERT THE THIRD COIL, IT WAS REPORTED THAT THE COIL ADVANCED MIDWAY THROUGH THE BROKEN/FRACTURED SUBJECT MICROCATHETER SHAFT INSTEAD THROUGH ITS DISTAL TIP. WHEN THE DEVICE WAS WITHDRAWN FROM THE PATIENT'S ANATOMY FOR EXAMINATION, THE SUBJECT MICROCATHETER TIP WAS FOUND BROKEN/FRACTURED. THE MICROCATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371745 ↗
• MalfunctionJun 1, 2022Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED SUBJECT AND THE PTFE (POLYTETRAFLUOROETHYLENE) INNER LINING WAS OBSERVED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569930 ↗
• MalfunctionFeb 8, 2022Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481911 ↗
• InjurySep 27, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN A-COM CEREBRAL ANEURYSM COIL EMBOLIZATION PROCEDURE, PHYSICIAN INSERTED THE SUBJECT CATHETER INTO THE ANEURYSM USING THE JAILED BALLOON TECHNIQUE AND EMBOLIZATION WAS PERFORMED AFTER PLACING A STENT. HE TRIED TO CHANGE THE POSITION OF THE SUBJECT CATHETER USING THE GUIDEWIRE AND TRIED TO RE-INSERT THE SUBJECT CATHETER INTO THE ANEURYSM USING TRANS CELL TECHNIQUE. WHEN THE GUIDEWIRE WAS REMOVED IT WAS SEEN THAT THE COATING WAS PEELED OFF. IT WASN¿T CONFIRMED IF THE PEELING WAS OF THE SUBJECT CATHETER OR THE GUIDEWIRE. THERE MIGHT BE SOME COATING FRAGMENTS LEFT INSIDE THE PATIENTS ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12531198 ↗
• MalfunctionAug 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT UPON DEPLOYMENT OF A COIL, THE PHYSICIAN NOTICED THAT THE SUBJECT MICROCATHETER WAS BEHAVING STRANGELY AND DID NOT HAVE ONE-TO-ONE FEEDBACK. THE COIL KEPT KICKING THE MICROCATHETER OUT OF THE ANEURYSM. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT'S ANATOMY, THE DISTAL PORTION OF THE CATHETER WAS FOUND BROKEN. THE TIP OF THE BROKEN CATHETER WAS FOUND INSIDE THE GUIDE CATHETER. ANOTHER SIMILAR MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316859 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EMBOLISM PROCEDURE, A DETACHMENT DEVICE WAS USED IN ATTEMPT TO DETACH A COIL AFTER ALIGNING THE MARKERS. AFTER 3 CYCLES, THE DELIVERY WIRE WAS PULLED, BUT THE COIL CAME ALONG WITH IT. THE MARKER WAS ALIGNED AGAIN AND THE DETACHMENT ATTEMPT OF THE COIL WAS PERFORMED AGAIN AND THE DELIVERY WIRE WAS PULLED. HOWEVER, THE COIL WAS STILL ATTACHED TO ITS DELIVERY WIRE AND WAS NOT DETACHED BUT WAS STUCK INSIDE THE SUBJECT MICROCATHETER. AN ATTEMPT WAS MADE TO REMOVE THE MICROCATHETER (SUBJECT DEVICE) FROM THE PATIENT¿S ANATOMY BUT WAS UNSUCCESSFUL. THE SUBJECT MICROCATHETER WAS TANGLED AND WAS STUCK WITH THE ALREADY DEPLOYED COIL MASS INSIDE THE ANEURYSM. TWO GUIDEWIRES WERE USED AS MEDICAL INTERVENTION TO REMOVE THE MICROCATHETER (SUBJECT DEVICE) FROM THE COIL MASS BUT WAS ALSO UNSUCCESSFUL. FINALLY, THE SUBJECT MICROCATHETER WAS REMOVED BY INFLATING ADDITIONAL BALLOON CATHETER. ADDITIONAL FORCE WAS APPLIED TO REMOVE THE SUBJECT MICROCATHETER WHILE THE BALLOON CATHETER WAS BEING INFLATED. WHEN REMOVED, THE STUCK COIL WAS FOUND AT THE TIP OF THE SUBJECT MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236297 ↗