EXCELSIOR XT-27Recalls & reported problems across all models
Stryker Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 3 models of EXCELSIOR XT-27 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2016 and Sep 25, 2026 — classified as 17 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Fracture” (39 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EXCELSIOR XT-27 problems
Device problems
- Fracture39
- Break9
- Adverse Event Without Identified Device or Use Problem8
- Material Puncture/Hole6
- Peeled/Delaminated5
- Component Missing1
- Deformation Due to Compressive Stress1
- Hole In Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient13
- Foreign Body In Patient8
- Device Embedded In Tissue or Plaque3
- No Known Impact Or Consequence To Patient3
- Hemorrhage/Blood Loss/Bleeding2
- Intracranial Hemorrhage2
- Stroke/CVA2
EXCELSIOR XT-27 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EXCELSIOR XT-27 M003XT2750810CATHETER, PERCUTANEOUS49 reports
- EXCELSIOR XT-27 M003XT2750910Catheter, continuous flush17 reports
- EXCELSIOR XT-27 M003XT2735810CATHETER, PERCUTANEOUS1 report
Recent EXCELSIOR XT-27 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fracture
It was reported that the microcatheter (Subject device) was used in the treatment of opthalmic artery aneurysm procedure. After the stent was advanced to the midsection of the subject microcatheter, resistance was encountered. The physician then increased the pushing force resulting in fracture to the hub of the subject device. The subject device was then withdrawn and replaced, and the procedure was reported to be completed successfully without any clinical consequence to the patient. However, when the subject device was returned for analysis the shaft of the subject device was observed to be kinked/bent, flat/crushed and had friction at the damaged sections. Also, the shaft of the subject device was noted to be broken/fractured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892962 ↗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 ↗MalfunctionApr 7, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE FOR A RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT ANEURYSM, THAT WHEN DEPLOYING A STENT IN PLACE AND PUSHING IT OUT BY APPROXIMATELY TWO-THIRDS, THE PHYSICIAN ENCOUNTERED ABNORMAL RESISTANCE WITHIN THE SUBJECT MICROCATHETER. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER SHAFT 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 24801582 ↗MalfunctionMar 6, 2026Fracture
ANALYSIS OF THE RETURNED MICROCATHETER DEVICE WAS FOUND THAT THE SHAFT OF THE SUBJECT MICROCATHETER DEVICE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24537159 ↗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 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INITIAL PROCEDURE OF THE STENT IMPLANTATION WAS CONDUCTED ON (B)(6) 2025 AS THE PATIENT HAD NO LIMB HEMIPLEGIA OR APHASIA AND CRANIAL AFTER SURGERY. AFTER THE PROCEDURE, THE DIAGNOSTIC IMAGING AND MRI (MAGNETIC RESONANCE IMAGING) SHOWED TWO ACUTE LACUNAR INFARCTION FOCI IN THE LEFT SUBCORTEX SENILE CEREBRAL CHANGES LEFT MAXILLARY SINUSITIS: MILD RIGHT MASTOID INFLAMMATION POSTOPERATIVE CHANGES OF THE LEFT OCULAR LENS. THE EVENT WAS CONSIDERED AS AN ISCHEMIC STROKE LOCATED AT IPSILATERAL AND IT WAS TREATED WITH MEDICATION. ONE DAY POST PROCEDURE ON (B)(6) 2025, THE PATIENT DEVELOPED BINOCULAR DIPLOPIA AS IT WAS RESOLVED ON (B)(6) 2025. THE PATIENT RECEIVED INTRAVENOUS INFUSION OF HUMAN ALBUMIN FOR VOLUME EXPANSION. LATER, A NEW LACUNAR CEREBRAL INFARCTION WAS DETECTED BY MRI, AND EDARAVONE DEXBORNEOL WAS ADMINISTERED TO SCAVENGE FREE RADICALS. IN PHYSICIAN¿S OPINION, THE CAUSE OF THE STROKE AND BINOCULAR DIPLOPIA AS THE STENT IMPLANTATION COVERS THE OPHTHALMIC ARTERY, CAUSING A THROMBOGENIC REACTION THAT AFFECTS THE BLOOD SUPPLY OF THE CENTRAL RETINAL ARTERY AND PROBABLY ALSO RELATED TO THE CATHETER (SUBJECT DEVICE). CURRENTLY, THERE IS NO IMPAIRMENT IN DAIL
Patient problems: Ischemia Stroke; Visual Disturbances
MAUDE report 24060000 ↗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 ↗MalfunctionJun 24, 2025Fracture; Fracture
THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DIRECTLY BELOW THE HUB. 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 22325009 ↗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 ↗
Other Stryker Corporation products
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- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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