EXCELSIOR XT-27 M003XT2750810Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 04546540698131), received between Jul 26, 2016 and Sep 15, 2026 — classified as 14 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Fracture” (29 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774069 ↗
• MalfunctionSep 9, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700270 ↗
• MalfunctionJul 21, 2026Fracture

  IT WAS REPORTED THAT DURING INTERNAL CAROTID ARTERY (ICA) C6 SEGMENT ANEURYSM PROCEDURE, THE PHYSICIAN FOUND THAT THE SUBJECT MICROCATHETER HAD FRACTURED AT POSITION APPROXIMATELY 20 CM AWAY FROM THE HUB DURING THE PROCESS OF PUSHING FORWARD THE SUBJECT FLOW DIVERTER STENT. 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 25888617 ↗
• MalfunctionMar 6, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A LESION LOCATED AT THE INTERNAL CAROTID ARTERY SEGMENT, AFTER THE GUIDEWIRE WAS POSITIONED, THE SUBJECT MICROCATHETER WAS ADVANCED OVER THE GUIDEWIRE TO THE TARGET SITE. DURING ADVANCEMENT, THE PROXIMAL PORTION OF THE SUBJECT MICROCATHETER FRACTURED. 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 24532572 ↗
• MalfunctionFeb 11, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT MICROCATHETER WAS USED TO ASSIST IN THE DEPLOYMENT OF THE FLOW DIVERTER STENT. AFTER THE PHYSICIAN HAD SUCCESSFULLY POSITIONED THE SUBJECT MICROCATHETER, THEY INTRODUCED A FLOW DIVERTER STENT FROM INTO THE SUBJECT MICROCATHETER. WHEN ATTEMPTING TO ADVANCE THE STENT FROM THE PROXIMAL END AT THE HUB OF THE SUBJECT MICROCATHETER, THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE AND WAS UNABLE TO PROCEED DESPITE MULTIPLE ATTEMPTS. UPON OBSERVATION, IT WAS FOUND THAT THE PROXIMAL END OF THE SUBJECT MICROCATHETER HAD FRACTURED. 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 24311054 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE MICROCATHETER (SUBJECT DEVICE) ASSOCIATED WITH THE STENT FOR ASSISTED COIL EMBOLIZATION OF AN ANEURYSM AT THE OPHTHALMIC ARTERY SEGMENT. AFTER NORMAL HYDRATION OF THE SUBJECT DEVICE, UNDER THE GUIDANCE OF A GUIDEWIRE, THE PHYSICIAN ATTEMPTED TO DELIVER THE SUBJECT DEVICE TO THE HORIZONTAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). WHEN SUBSEQUENTLY ADVANCING IT WITH NORMAL FORCE TO THE CAVERNOUS SINUS SEGMENT, THE YELLOW BUFFER ZONE AT THE PROXIMAL END OF THE SUBJECT DEVICE RUPTURED. THE PHYSICIAN THEN WITHDREW THE SUBJECT DEVICE OUT OF THE BODY, SELECTED ANOTHER MICROCATHETER, SUCCESSFULLY DELIVERED IT TO THE TARGET LOCATION, AND SMOOTHLY DEPLOYED THE STENT. FINALLY, AFTER PASSING COILS THROUGH THE STENT MESH AND FILLING THREE COILS, THE PROCEDURE WAS CONCLUDED WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874121 ↗
• MalfunctionDec 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN FOLLOWED THE STANDARD PROCEDURE TO PLACE THE SUBJECT CATHETER, AND NO RESISTANCE WAS ENCOUNTERED THROUGHOUT THE PROCESS. HOWEVER, WHILE REVIEWING THE X-RAY, THEY NOTICED AN ABNORMAL SPOT, WHICH WAS LATER IDENTIFIED AS THE TIP OF THE SUBJECT CATHETER APPEARING UNEVEN (POSSIBLY CRACKED). THE PATIENT REMAINED CLINICALLY STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791754 ↗
• MalfunctionAug 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT OPHTHALMIC SEGMENT ANEURYSM PROCEDURE, A FLOW DIVERTER (FD) STENT IMPLANTATION WAS PLANNED. THE OPERATOR ESTABLISHED ACCESS AND USED A GUIDEWIRE TO ADVANCE THE SUBJECT MICROCATHETER TO THE M1 SEGMENT OF THE MIDDLE CAROTID ARTERY (MCA). NEXT, THE FD STENT WAS DELIVERED THROUGH THE SUBJECT MICROCATHETER TO THE TARGET LESION. THE OPERATOR POSITIONED AND RETRACTED THE SUBJECT MICROCATHETER TO DEPLOY THE STENT BUT FOUND THAT THE STENT FAILED TO OPEN. THE OPERATOR ATTEMPTED TO RETRACT AND REDEPLOY THE STENT BUT IT DID NOT RESULT IN ITS OPENING. THE OPERATOR THEN WITHDREW THE ENTIRE STENT SYSTEM OUT OF THE PATIENT'S ANATOMY AND DISCOVERED THAT THE TIP OF THE SUBJECT MICROCATHETER HAD FRACTURED AND WAS ENCASED AROUND THE STENT, PREVENTING ITS EXPANSION. 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 22867382 ↗
• MalfunctionMay 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ELONGATED INTERNAL CAROTID ARTERY WITH MULTIPLE HAIRPIN BENDS MADE IT DIFFICULT TO REACH THE OCCLUSION. THE PHYSICIAN REMOVED THE SUBJECT MICROCATHETER WITH THE GUIDEWIRE FROM THE PATIENT. THE SUBJECT MICROCATHETER AND GUIDEWIRE WERE BROKEN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080109 ↗
• MalfunctionMay 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT IN THE CASE OF A PATIENT WITH LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION, THE PHYSICIAN PLANNED TO PERFORM BALLOON ANGIOPLASTY FOLLOWED BY STENT IMPLANTATION. AFTER ESTABLISHING THE SYSTEM, THE PHYSICIAN FIRST SUCCESSFULLY PERFORMED BALLOON DILATION. WHEN ATTEMPTING TO IMPLANT THE STENT, IT PERFORATED THE SIDE WALL OF THE DISTAL END OF THE SUBJECT MICROCATHETER DURING DELIVERY, WITH A SECTION PROTRUDING WHILE THE MAIN BODY REMAINED WITHIN THE LUMEN OF THE SUBJECT MICROCATHETER. THE 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 21973862 ↗
• MalfunctionJan 2, 2025Fracture; Fracture

  THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SHAFT OF THE SUBJECT CATHETER WAS FOUND TO BE 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 21061035 ↗
• MalfunctionOct 29, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560441 ↗
• InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE CAROTID ANEURYSM OPHTHALMIC SEGMENT PROCEDURE, THE SUBJECT MICROCATHETER WAS POSITIONED IN THE LEFT M1. THE PHYSICIAN BEGAN TO RELEASE THE FLOW DIVERTER IN THE MIDDLE CEREBRAL ARTERY (MCA) BUT IT WAS NOT ANCHORED AND PROGRESSED TO THE M2. THE FLOW DIVERTER WAS REQUIRED TO BE RECAPTURED THREE TIMES TO ACHIEVE THE CORRECT ANCHORING. THE FLOW DIVERTER WAS RELEASED BUT THE PROXIMAL END DID NOT OPEN CORRECTLY. THE SUBJECT MICROCATHETER WAS USED TO ATTEMPT OPENING OF THE PROXIMAL SECTION OF THE SUBJECT FLOW DIVERTER. THERE WAS A RUPTURE OF THE INTERNAL CAROTID ARTERY TO THE CAVERNOUS SINUS AS A RESULT OF THE SUBJECT MICROCATHETER. THIS WAS OCCLUDED WITH PLATINUM COILS FROM BOTH ARTERIAL AND VENOUS APPROACH. THE PATIENT WAS EVALUATED AT THE OUTPATIENT CLINIC ON THE 4TH DAY OF TREATMENT, IN PERFECT HEALTH. ADDITIONAL INFORMATION RECEIVED STATED THAT 10 DAYS POST PROCEDURE PATIENT PRESENTED WITH SEVERE ANTEROGRADE MEMORY DEFICIT, THE NEXT DAY RIGHT HEMI BODY PARESTHESIA UPON AWAKENING, THEN ADDED MOTOR DEFICIT, APHASIA, AND ABOUT 2 HOURS LATER LOSS OF CONSCIOUSNESS. CT (COMPUTED TOMOGRAPHY) REVEALED SUBARACHNOID HEMORRHAGE, MRI (MAGNETIC RESONANCE IMAGING) OB

  Patient problems: Fistula; Perforation

  MAUDE report 20107508 ↗
• MalfunctionAug 8, 2024Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE AND CATHETER TIP WAS BROKEN/FRACTURED 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 19942873 ↗
• MalfunctionMay 24, 2024Material Puncture/Hole; Material Puncture/Hole

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) SHAFT HAD A HOLE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397209 ↗
• InjuryApr 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, A FLOW DIVERTER DID NOT OPEN, SO THE PHYSICIAN DECIDED TO RESHEATH THE FLOW DIVERTER AND TAKE THE SUBJECT MICROCATHETER OUT OF THE PATIENT ANATOMY. PHYSICIAN USED A NEW MICROCATHETER AND FLOW DIVERTER TO FINISH THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE PHYSICIAN FOUND A METAL PART IN THE PATIENT'S ARTERY. PHYSICIAN MADE A X-RAY OF THE SUBJECT MICROCATHETER TIP AND SAW THAT THE METAL PART SEEMS TO BE THE MARKER OF THE SUBJECT MICROCATHETER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19198719 ↗
• MalfunctionMar 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, THE DISTAL MARKER BAND ON THE SUBJECT MICROCATHETER SEPARATED DURING USE AND WAS LODGED DISTAL IN MCA (MIDDLE CEREBRAL ARTERY) , FAR IN PATIENTS ANTERIOR CIRCULATION. IT WAS REPORTED THAT THE PATIENT WAS NOT HURT IN THE PROCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19007129 ↗
• InjuryMar 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING MCA (MIDDLE CEREBRAL ARTERY) STENOSIS CASE, THE OPERATOR USED BALLOON TO DILATE FIRST AND THEN PREPARED TO DEPLOY STENT TO EXPAND THE LESION. DELIVERED THE STENT ALONG WITH THE GUIDEWIRE TO GO THROUGH THE SUBJECT CATHETER, AND AFTER THE SUBJECT CATHETER WAS ADVANCED IN PATIENT'S BODY FOR ABOUT 140CM RESISTANCE WAS ENCOUNTERED AND THE OPERATOR COULD NOT SEE THE TIP MARKER OF THE SUBJECT CATHETER UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) EVEN AFTER SEVERAL ADJUSTMENTS. AFTER THE PROCEDURE THE OPERATOR CHECKED THE SUBJECT CATHETER AND FOUND THE TIP MARKER RING WAS MISSING. CHECKED WITH CT (COMPUTED TOMOGRAPHY) AND FOUND METAL MATTER IN PATIENT'S HEAD AND IT SUPPOSED TO BE THE MARKER OF THE SUBJECT CATHETER. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 STATED THAT MEDICAL INTERVENTION WAS PERFORMED TO REMOVE CATHETER TIP MARKER AND PATIENT'S MUSCLE TONE INCREASED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDIOTNAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient; Muscular Rigidity

  MAUDE report 18981341 ↗
• MalfunctionNov 18, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT CATHETER TIP WAS BROKEN/FRACTURED DURING USE. 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 18166597 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT CATHETER WAS USED DURING A NEUROVASCULAR PROCEDURE. FOLLOWING THE PROCEDURE A ANGIOGRAM WAS PERFORMED AND A BLEED WAS NOTICED. PATIENT REQUIRED A EV (EXTERNAL VENTRICULAR) DRAIN TO BE PLACED .THE PHYSICIAN USED COILS TO STOP THE BLEED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17264309 ↗
• InjuryJun 29, 2023Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT CATHETER TIP WAS BROKEN OFF. AN ATTEMPT WITH AN UNKNOWN DEVICE WAS MADE TO REMOVE THE BROKEN TIP, BUT WAS UNSUCCESSFUL. NO OTHER INFORMATION WAS GIVEN. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 17-JULY-2023, THAT THE SAME REPORTED EVENT DETAILS, FACILITY, DEVICE AND LOT #, AND EVENT DATE CAPTURED IN THIS EVENT WAS ALREADY CAPTURED UNDER MFR REPORT NUMBER: 3008881809-2023-00309. THEREFORE THIS COMPLAINT NO LONGER MEETS REPORTING CRITERIA AND A SUPPLEMENTAL WILL BE FILED AS A DUPLICATE/CANCELLATION RECORD.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233937 ↗
• InjuryJun 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE PERFORMING A MECHANICAL THROMBECTOMY ON AN EMERGENT STROKE PATIENT, THE TIP OF THE MICROCATHETER (SUBJECT DEVICE) FRACTURED OFF FROM THE CATHETER INTO THE PATIENT'S HEAD. THE TIP OF THE CATHETER (SUBJECT DEVICE) WAS NOT IN A RETRIEVABLE DISPOSITION. THE CATHETER (SUBJECT DEVICE) WAS PULLED OFF OF THE STERILE FIELD. NO ADDITIONAL INFORMATION AVAILABLE. UPDATE: ADDITIONAL INFORMATION RECEIVED ON 28-JUN-2023 STATED THAT THE CATHETER TIP WAS BROKEN/FRACTURED DURING USE. THE CATHETER TIP (SUBJECT DEVICE) WAS NOT IN A RETRIEVABLE DISPOSITION WHICH CAUSED METICULOUS STRIDAL STROKE. PATIENT PASSED AWAY TWO DAYS POST PROCEDURE DUE TO FAMILY WITHDREW CARE AND STROKE (PATIENT¿S INITIAL PRE- PROCEDURE/INDEX CONDITION WAS STROKE). THEN, ADDITIONAL INFORMATION RECEIVED ON 06-JUL-2023 STATED THAT THE SUBJECT DEVICE IS NOT RESPONSIBLE FOR THE DEATH OF THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient; Stroke/CVA

  MAUDE report 17160055 ↗
• MalfunctionFeb 24, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT MICROCATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. 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 16440709 ↗
• MalfunctionSep 13, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PICA (POSTERIOR INFERIOR CEREBELLAR ARTERY) ANEURYSM EMBOLIZATION PROCEDURE, AFTER FLUSHING THE SUBJECT MICROCATHETER, OPERATOR FOUND THAT THERE WAS SOME PROBLEM WITH THE PTFE INNER LINING PEELING OFF THE TIP OF THE SUBJECT MICROCATHETER AND RESISTANCE WAS ENCOUNTERED AT THE TIP OF THE SUBJECT CATHETER. ALSO, THE ENTRY AND EXIT OF THE SHAPING NEEDLE WERE NOT SMOOTH WHEN SHAPING IT. 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 15415406 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST PROCEDURE, PATIENT CAME WITH STROKE SYMPTOMS AND MRI CONFIRMED MICRO-BLEEDS IN THE BRAIN. PATIENT WAS HOSPITALIZED AND NEEDED MEDICATION TO RETURN TO BASELINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 14038136 ↗