Surpass EliteRecalls & reported problems across all models
Stryker Corporation · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 17 models of Surpass Elite by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2024 and Aug 7, 2026 — classified as 13 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (9 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 Surpass Elite problems
Device problems
- Activation Failure9
- Adverse Event Without Identified Device or Use Problem5
- Difficult to Remove5
- Malposition of Device4
- Deformation Due to Compressive Stress3
- Premature Activation3
- Fracture2
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Thrombosis/Thrombus7
- Obstruction/Occlusion4
- Stroke/CVA4
- Muscle Weakness/Atrophy1
- Paralysis1
- Speech Disorder1
- Stenosis1
Surpass Elite models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surpass Elite FDSE32512Intracranial aneurysm flow diverter4 reports
- Surpass Elite FDSE45020Intracranial aneurysm flow diverter3 reports
- Surpass Elite FDSE32517Intracranial aneurysm flow diverter2 reports
- Surpass Elite FDSE40012Intracranial aneurysm flow diverter2 reports
- Surpass Elite FDSE45015Intracranial aneurysm flow diverter2 reports
- Surpass Elite FDSE50015Intracranial aneurysm flow diverter2 reports
- Surpass Elite FDSE50040Intracranial aneurysm flow diverter2 reports
- Surpass Elite FDSE32525Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE40015Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE40020Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE45017Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE45030Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE50017Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE50030Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE52525Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE52540Intracranial aneurysm flow diverter1 report
- Surpass Elite FDSE42512Intracranial aneurysm flow diverter1 report
Recent Surpass Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Difficult to Remove
It was reported that the stent (Subject device) was used in the Left Middle Cerebral Artery aneurysm embolization. However, during deployment the physician could neither recapture the stent within microcatheter nor push the stent out of microcatheter. After multiple attempts the physician advanced the intermediate catheter and recaptured the subject device. No further information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181606 ↗MalfunctionApr 6, 2026Difficult to Remove
IT WAS REPORTED THAT WHEN TRYING TO DEPLOY THE SUBJECT STENT, IT WOULD NOT RE-SHEATH. THE SUBJECT STENT WAS STUCK AND WOULDN'T RECAPTURE SO THE SYSTEM WAS REMOVED. THE SUBJECT DEVICE WAS REPLACED WITH AN ALTERNATIVE DEVICE, 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 24791428 ↗InjuryMar 30, 2026Malposition of Device; Activation Failure
IT WAS REPORTED THAT DURING A PROCEDURE THE PHYSICIAN NOTICED SOME RIBBONING AROUND THE GENU AND WERE ABLE TO WORK OUT THE RIBBON AFTER AWHILE WHICH LED THE PHYSICIAN TO FEEL COMFORTABLE TO DEPLOY THE SUBJECT STENT. ONCE DEPLOYED, THE PHYSICIAN NOTICED THE SUBJECT STENT DID NOT OPEN MUCH MORE THAN IT SHOWED AROUND THE ANTERIOR GENU. THE SUBJECT STENT WAS TWISTED/TORQUED. ONCE THE PHYSICIAN WAS ABLE TO GET THROUGH THE TWISTED PART OF THE SUBJECT STENT, THE PHYSICIAN DECIDED TO DEPLOY A RETRIEVER AND WAS ABLE TO OPEN THE DEVICE ENOUGH TO HELP GET A BALLOON CATHETER THROUGH. THE PHYSICIAN THEN INFLATED THE BALLOON AND THE STENT FINALLY OPENED. THERE WAS SURGICAL DELAY OF 1.5HRS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728842 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SUBJECT STENT IMPLANTATION ON (B)(6) 2026, THE SUBJECT STENT FAILED TO OPEN AT THE PROXIMAL END THUS, BALLOON ANGIOPLASTY WAS PERFORMED. ON (B)(6) 2026, PATIENT PRESENTED WITH STROKE SYMPTOMS DUE TO M1 OCCLUSION IN DISTAL STENT AND DELAYED THROMBOSIS. THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY TO REMOVE CLOT FROM M1. THE PATIENT HAD PROLONGED HOSPITALIZATION FOR 1 WEEK AND HAD APHASIA.
Patient problems: Obstruction/Occlusion; Speech Disorder; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 24532571 ↗MalfunctionFeb 27, 2026Activation Failure
IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED ON (B)(6) 2026 AND THE PATIENT DEVELOPED HEMIPLEGIA ON (B)(6) 2026. AFTER THE PHYSICIAN PERFORMED HEAD COMPUTED TOMOGRAPHIC SCAN, CLOT WAS CONFIRMED TO BE PRESENT WITHIN THE SUBJECT STENT. THUS, MECHANICAL THROMBECTOMY WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED ON 04-FEB-2026 CONFIRMED THAT THERE WAS UNKNOWN SLIPPAGE OF GASTRIC SLEEVE AND THE CLOT FORMATION WAS DUE TO MALABSORPTION OF DUAL ANTI-PLATELET THERAPY (DAPT). SUBSEQUENTLY, INFORMATION RECEIVED ON 18-FEB-2026 CONFIRMED THAT THE SUBJECT STENT FAILED TO OPEN AT THE PROXIMAL END (PROXIMAL LEDGE) AND A BALLOON ANGIOPLASTY WAS PERFORMED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471647 ↗MalfunctionFeb 17, 2026Difficult to Remove
IT WAS REPORTED THAT DURING ANEURYSM TREATMENT PROCEDURE, THE SUBJECT STENT WOULD NOT RESHEATH DESPITE MULTIPLE ATTEMPTS WITH MICROCATHETER. PHYSICIAN EVENTUALLY GAVE UP ON RESHEATHING AND DEPLOYED THE STENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361529 ↗InjuryJan 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE PATIENT DEVELOPED VISUAL SCOTOMA/BRANCH RETINAL OCCLUSION POST PROCEDURE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Obstruction/Occlusion; Visual Disturbances
MAUDE report 24105502 ↗InjuryDec 23, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE STENT WAS FLATTENED, AND THE MID-SECTION OF THE STENT DIDN'T OPEN COMPLETELY. THE CLOT WENT DISTAL AND MAY RESULTED IN A STROKE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Paralysis; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 23879076 ↗MalfunctionDec 18, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT ENCOUNTERED FRICTION WHEN ATTEMPTING TO RE-SHEATH WITH MICROCATHETER. PHYSICIAN WAS NOT ABLE TO RE-SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843249 ↗MalfunctionDec 17, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT WAS UNABLE TO RESHEATH INTO THE MICROCATHETER INSIDE THE PATIENT'S BODY. THE SUBJECT STENT WAS REMOVED ALONG WITH 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829963 ↗InjuryDec 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, AFTER DEPLOYMENT OF THE STENT THE PROXIMAL SECTION OF THE STENT FISH MOUTHED. THE PHYSICIAN USED DIFFERENT TECHNIQUES USING BALLOON, MICROCATHETER TO OPEN THE STENT, HOWEVER ENDED UP BY IMPLANTING ANOTHER SNARE STENT TO OPEN THE PROXIMAL SECTION OF THE SUBJECT STENT. THE PHYSICIAN REPORTED FORMATION OF CLOT NEAR THE STENT THUS ADDITIONAL MEDICATIONS WERE PROVIDED TO THE PATIENT. THE PROCEDURE WAS DELAYED FOR SEVERAL HOURS, AND THE PATIENT WAS KEPT ON ADDITIONAL RADIATION TIME. THE PROCEDURE WAS REPORTED TO BE COMPLETED, AND THE PATIENT WAS REPORTED TO BE WELL.
Patient problems: Thrombosis/Thrombus; Unintended Radiation Exposure
MAUDE report 23790429 ↗InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBJECT STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2025. APPROXIMATELY 7 DAYS POST PROCEDURE IT WAS REPORTED THAT THE SUBJECT STENT WAS OCCLUDED. A POST OPERATIVE THROMBECTOMY WAS PERFORMED (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Thrombosis/Thrombus
MAUDE report 23633147 ↗MalfunctionNov 21, 2025Fracture; Fracture
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT STENT 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 23613676 ↗MalfunctionAug 21, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE SUBJECT STENT IMPLANTATION PROCEDURE FOR ICA INTERNAL CAROTID ARTERY TERMINUS WAS SUCCESSFULLY COMPLETED ON (B)(6) 2025. PATIENT CAME BACK IN WITH A STROKE A WEEK LATER DUE TO FAILING TO TAKE THEIR DAPT DUAL ANTI PLATELET THERAPY PROTOCOL AND WHILE ACCESSING THE PATIENT TO ASPIRATE THE CLOT PHYSICIAN NOTICED THE DISTAL END OF THE SUBJECT STENT WAS "FISHMOUTHED" OR LOST APPOSITION. PHYSICIAN ALSO NOTICED THAT THE MID SECTION OF THE SUBJECT STENT OPENED UP INTO THE NECK MORE BASED OFF THE MEASUREMENTS WHICH COULD HAVE POTENTIALLY PULLED THE DISTAL END OF THE SUBJECT STENT BACK OR STRETCHED THE DEVICE. CURRENTLY, PATIENT IS DOING WELL AND TAKING THEIR DAPT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22867971 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS USED ON (B)(6) 2025. THERE WERE NO ISSUES WITH THE SUBJECT DEVICE DURING THE PROCEDURE AS THE SUBJECT DEVICE WAS PREPPED PER IFU. THE PATIENT WAS ON DUAL ANTI PLATELET, NO THROMBOEMBOLIC EVENTS DURING THE PROCEDURE. PROXIMAL END WAS MALPOSED AND AFTER RUNNING THE INTERMEDIATE CATHETER THROUGH THE DEPLOYED SUBJECT DEVICE, GOOD APPOSITION WAS NOTED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT DID VERY WELL AND WAS DISCHARGED ON (B)(6) 2025. POST PROCEDURE ON (B)(6) 2025, THE PATIENT DEVELOPED STROKE LIKE SYMPTOMS AND A MECHANICAL THROMBECTOMY WAS PERFORMED AT ANOTHER HOSPITAL WITH A DIFFERENT PHYSICIAN. AN ANGIOGRAM SHOWED THE SUBJECT DEVICE WAS OCCLUDED. PATIENT STOPPED TAKING THEIR DUAL ANTIPLATELET MEDICATIONS SINCE BEING DISCHARGED ON (B)(6) 2025 RESULTING IN THE FORMATION OF THROMBUS THROUGHOUT THE ENTIRE SUBJECT DEVICE AND THE THROMBECTOMY. BASED ON THE PHYSICIAN¿S OPINION STATED THAT THE REPORTED EVENT DUE TO THE LACK OF DUAL ANTIPLATELET THERAPY CAUSING CLOT FORMATION WITHIN THE SUBJECT DEVICE. THE PATIENT IS ALIVE WITH DEFICITS AND IS STILL IN HOSPITAL BEING MEDICALLY MANAGED FOR HYDROCEPHALUS.
Patient problems: Stroke/CVA; Thrombosis/Thrombus
MAUDE report 22728278 ↗
Other Stryker Corporation products
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- Prime Series21 models · 1,548 reports · 2 recalls
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- 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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