Surpass EvolveRecalls & reported problems across all models
Stryker Corporation · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 144
- Deaths reported
- 5
- Injuries reported
- 104
- Recalls
- 0
We found 22 models of Surpass Evolve by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 144 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2020 and Mar 9, 2026 — classified as 5 deaths, 104 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (27 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 Evolve problems
Device problems
- Adverse Event Without Identified Device or Use Problem74
- Activation Failure27
- Premature Activation20
- Deformation Due to Compressive Stress8
- Difficult to Remove8
- No Apparent Adverse Event7
- Migration6
- Difficult or Delayed Activation5
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Stenosis29
- Headache27
- Stroke/CVA20
- Thrombosis/Thrombus15
- Visual Disturbances13
- Paresis7
- Blurred Vision6
Surpass Evolve models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surpass Evolve FDS40017Intracranial aneurysm flow diverter3 deaths23 reports
- Surpass Evolve FDS40015Intracranial aneurysm flow diverter14 reports
- Surpass Evolve FDS45017Intracranial aneurysm flow diverter14 reports
- Surpass Evolve FDS40020Intracranial aneurysm flow diverter12 reports
- Surpass Evolve FDS45020Intracranial aneurysm flow diverter1 death10 reports
- Surpass Evolve FDS45015Intracranial aneurysm flow diverter9 reports
- Surpass Evolve FDS40012Intracranial aneurysm flow diverter9 reports
- Surpass Evolve FDS32512Intracranial aneurysm flow diverter8 reports
- Surpass Evolve FDS45012Intracranial aneurysm flow diverter7 reports
- Surpass Evolve FDS50015Intracranial aneurysm flow diverter6 reports
- Surpass Evolve FDS50040Intracranial aneurysm flow diverter5 reports
- Surpass Evolve FDS32515Intracranial aneurysm flow diverter4 reports
- Surpass Evolve FDS45040Intracranial aneurysm flow diverter4 reports
- Surpass Evolve FDS50020Intracranial aneurysm flow diverter4 reports
- Surpass Evolve FDS50030Intracranial aneurysm flow diverter3 reports
- Surpass Evolve FDS50012Intracranial aneurysm flow diverter3 reports
- Surpass Evolve FDS40025Intracranial aneurysm flow diverter2 reports
- Surpass Evolve FDS40030Intracranial aneurysm flow diverter1 death2 reports
- Surpass Evolve FDS45025Intracranial aneurysm flow diverter2 reports
- Surpass Evolve FDS32525Intracranial aneurysm flow diverter1 report
- Surpass Evolve FDS45030Intracranial aneurysm flow diverter1 report
- Surpass Evolve FDS50017Intracranial aneurysm flow diverter1 report
Recent Surpass Evolve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBJECT STENT PROCEDURE WAS SUCCESSFULLY COMPLETED ON 22-SEP-2022. POST PROCEDURE ON (B)(6) 2025, PATIENT DEVELOPED AE7 (ACUTE LEFT VISUAL DEFICIT) THAT RESULTED IN CONCOMITANT OR ADDITIONAL TREATMENT GIVEN AND REFERRAL TO OPHTHALMOLOGIST. THE PATIENT RECEIVED DUAL ANTIPLATELET THERAPY DAPT PRIOR TO PROCEDURE IN ACCORDANCE WITH INSTITUTIONAL STANDARD OF CARE AND THE ANTIPLATELET TEST ESTABLISHED EFFECTIVENESS. THIS EVENT WAS POSSIBLY RELATED TO STUDY PROCEDURE AND STUDY DEVICE. IT WAS POSSIBLY DUE TO EMBOLISM FROM STENT THROUGH OPHTHALMIC ARTERY TO INJURE RETINA. THE EVENT IS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Thromboembolism; Visual Disturbances
MAUDE report 24553656 ↗InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT BEGUN HAVING EPISODES OF INCREASED TIREDNESS, FATIGUE, AND WEAKNESS. THE SYMPTOMS WOULD COMPLETELY RESOLVE AT TIMES, HOWEVER, WHEN THEY WOULD RETURN THE PATIENT WOULD BE VERY UNSTABLE ON HER FEET. THE PATIENT FELL 2-3 TIMES DUE TO THIS WEAKNESS AND IMBALANCE.
Patient problems: Dizziness; Fatigue
MAUDE report 22790234 ↗InjuryJun 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PROCEDURE AT LEFT INTERNAL CAROTID ARTERY (ICA) PARAOPHTHALMIC ANEURYSM USING A COMBINATION OF COILS AND A FLOW-DIVERTING STENT. THE PHYSICIAN FIRST GAINED ACCESS INTO THE M1 SEGMENT WITH THE MICROCATHETER, FOLLOWED BY ACCESS INTO THE ANEURYSM USING ANOTHER MICROCATHETER. THE PHYSICIAN INITIALLY POSITIONED BUT DID NOT DEPLOY THE COIL, THEN BEGAN UNSHEATHING THE DISTAL END OF THE SUBJECT STENT IN THE SUPRACLINOID SEGMENT OF THE ICA. HE CONTINUED TO UNSHEATH THE DEVICE AND DEPLOYED THE PROXIMAL END OF THE SUBJECT STENT NEAR THE DISTAL PORTION OF THE ANTERIOR GENU (BEFORE THE TURN). HE THEN DEPLOYED THE INITIAL COIL AND PLACED THREE ADDITIONAL COILS. FOLLOWING THE COILING, THE SECOND MICROCATHETER WAS REMOVED, AND ANGIOGRAPHIC IMAGING WAS PERFORMED. A PROXIMAL FISHMOUTH OR LEDGE WAS OBSERVED ON THE SUBJECT STENT. POST-PROCEDURE, THE PATIENT EXPERIENCED A STROKE IN THE ICU (INTENSIVE CARE UNIT). IMAGING REVEALED THROMBUS ACCUMULATION ON BOTH THE PROXIMAL AND DISTAL ENDS OF THE SUBJECT STENT. THE PHYSICIAN ADVANCED THE CATHETERS AND PERFORMED ONE ASPIRATION PASS. HE THEN TRACKED A WIRE THROUGH THE PROXIMAL STENT INTO THE LUMEN AND INTO THE MIDDLE CEREBRAL A
Patient problems: Stroke/CVA; Thrombosis/Thrombus
MAUDE report 22146550 ↗InjuryMay 27, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING TARGET SACCULAR ANEURYSM AT LEFT INTERNAL CAROTID ARTERY-COMMUNICATING PROCEDURE, THE DISTAL END OF THE SUBJECT FLOW DIVERTER STENT DID NOT OPEN COMPLETELY, THIS PERSISTED AFTER ANGIOPLASTY AND SO AN ADDITIONAL STENT WAS PLACED. 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 22091406 ↗InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A FOLLOW UP AFTER A POST-IMPLANTATION PROCEDURE OF THE SUBJECT FLOW DIVERTER STENT THE PATIENT EXPERIENCED SEVER HEADACHE, STAGGERING, IMBALANCE AND A STROKE. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) WAS PERFORMED DURING WHICH AN ACUTE LACUNAR INFARCT OF THE RIGHT CENTRAL PONS WAS DISCOVERED. THE CURRENT PATIENT'S CONDITION IS RECOVERING/RESOLVING. UPDATE: ADDITIONAL INFORMATION RECEIVED ON 23 MAY 2025 CONFIRMED THAT THE ADVERSE EVENT STROKE IS NOT RELATED TO THE STUDY DEVICE.
Patient problems: Headache; No Clinical Signs, Symptoms or Conditions; Stroke/CVA
MAUDE report 21940109 ↗InjuryMar 14, 2025Deformation Due to Compressive Stress; Activation Failure; Deformation Due to Compressive Stress; Activation Failure
IT WAS REPORTED THAT DURING PROCEDURE THERE WAS A SMALL LEDGE ON THE SUBJECT STENT AND THE ANATOMY WAS ABNORMAL, SO BALLOON USED TO CONFIRM FULL APPOSITION OF THE SUBJECT FLOW DIVERTER STENT. THEN DURING 6 MONTH FOLLOW UP, THE SUBJECT STENT WAS FISH MOUTHED OR TAPERED AT THE END. PATIENT IS PLANNED FOR BALLOON ANGIOPLASTY ON (B)(6) 2025. THERE IS NO OTHER CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21610659 ↗InjuryJan 13, 2025Activation Failure; Migration; Activation Failure; Migration
IT WAS REPORTED THAT DURING PROCEDURE DEPLOYMENT ATTEMPTS FOR TWO STENTS. THE SUBJECT STENT FAILED TO OPEN PROPERLY DUE TO SIGNIFICANT RESISTANCE CAUSED BY TORTUOSITY AND HIGH RIDING GENU. THE DISTAL SEGMENT OF THE STENT DID NOT OPPOSE WELL, AND THE MID-SEGMENT FAILED TO OPEN, LEADING TO PROXIMAL MIGRATION OF THE STENT. TO ADDRESS THIS, THE PHYSICIAN USED ADDITIONAL STENT TO TACK DOWN THE UNOPENED SECTION OF THE STENT, SUCCESSFULLY RESTORING NORMAL LUMEN AND COMPLETING THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY. RESISTANCE WAS ENCOUNTERED THROUGHOUT THE PROCEDURE, PRIMARILY DUE TO THE SEVERE TORTUOSITY IN THE ICA (INTERNAL CAROTID ARTERY) AND THE ARTERY SIZE (5MM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138612 ↗InjuryJan 13, 2025Activation Failure; Migration; Activation Failure; Migration
IT WAS REPORTED THAT DURING PROCEDURE DEPLOYMENT ATTEMPTS FOR TWO STENTS. THE SUBJECT STENT FAILED TO OPEN PROPERLY DUE TO SIGNIFICANT RESISTANCE CAUSED BY TORTUOSITY AND HIGH RIDING GENU. THE DISTAL SEGMENT OF THE STENT DID NOT OPPOSE WELL, AND THE MID-SEGMENT FAILED TO OPEN, LEADING TO PROXIMAL MIGRATION OF THE STENT. TO ADDRESS THIS, THE PHYSICIAN USED ADDITIONAL STENT TO TACK DOWN THE UNOPENED SECTION OF THE STENT, SUCCESSFULLY RESTORING NORMAL LUMEN AND COMPLETING THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY. RESISTANCE WAS ENCOUNTERED THROUGHOUT THE PROCEDURE, PRIMARILY DUE TO THE SEVERE TORTUOSITY IN THE ICA (INTERNAL CAROTID ARTERY) AND THE ARTERY SIZE (5MM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138611 ↗MalfunctionDec 4, 2024Premature Activation; Premature Activation
IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE THIRD RE-SHEATH THE SUBJECT STENT CAME OFF THE RE-SHEATH PAD PREMATURELY. THE PHYSICIAN DEPLOYED THE SUBJECT STENT IN THE MICROCATHETER BEFORE REMOVING BOTH DEVICES FROM THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844931 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT LEFT INTERNAL CAROTID ARTERY ICA PARA CLINOID ANEURYSM PROCEDURE WAS PERFORMED WITH THE SUBJECT STENT ON (B)(6) 2023. SUBSEQUENT DCA SHOWED INTIMAL HYPERPLASIA, BUT IT WAS STABLE ON AN 18-MONTH DCA SO PLAVIX WAS STOPPED. ASPIRIN 81 WAS MAINTAINED. THEN PATIENT CAME TO ED FOR IPSILATERAL VISUAL DEFICITS AND CTA COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED SUBJECT STENT HAS THROMBOSED COMPLETELY. PATIENT HAS MILD SYMPTOMS, AND NO SUBSEQUENT INTERVENTION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Stenosis; Thrombosis/Thrombus; Visual Disturbances
MAUDE report 20563613 ↗InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER PERFORMED AS INTENDED DURING THE PROCEDURE AND IMPLANTATION AT FUSIFORM DISTAL ICA (INTERNAL CAROTID ARTERY) ANEURYSM. DURING A FOLLOW-UP DIAGNOSTIC APPOINTMENT , MAL APPREHENSION (NARROWED AND NOT APPOSED) WAS OBSERVED IN THE SUBJECT'S PROXIMAL STENT. 90% FISH-MOUTHING WAS OBSERVED ON THE PROXIMAL END OF THE SUBJECT STENT DURING THE FOLLOW-UP NOT CAUSED BY HYPERPLASIA OR THROMBOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Stenosis
MAUDE report 20189875 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INITIAL SUBJECT STENT IMPLANTATION PROCEDURE AT THE INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) WAS CARRIED OUT SUCCESSFULLY VIA RIGHT RADIAL ARTERY. DURING FOLLOW UP PATIENT PRESENTS WITH 50-75% PARENT ARTERY STENOSIS WITHIN THE SUBJECT FLOW DIVERTER EVIDENCED ON THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE PATIENT'S CURRENT CONDITION DESCRIBED AS GOOD, BOTH MRS & NIHSS AS 0.
Patient problems: Stenosis
MAUDE report 20138538 ↗InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT POST SUBJECT STENT IMPLANTATION PROCEDURE AT THE INTERNAL CAROTID ARTERY-COMMUNICATING (C7 SEGMENT), DURING A FOLLOW UP, THE PATIENT REPORTED TO HAVE "VISION SPELLS" AND A HEADACHE. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND NO NEW ANEURYSMS WERE FOUND, RELATIVELY DECREASED FLOW IN RIGHT MCA AS COMPARED TO PREVIOUS SCANS. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY THROUGH RIGHT RADIAL ARTERY. NO ADDITIONAL TREATMENT WAS ADMINISTERED DUE TO THIS EVENT, BUT THE PATIENT WAS ADVISED TO RESUME THE INITIALLY PRESCRIBED TREATMENT AS SHE HAS STOPPED.
Patient problems: Headache; Visual Disturbances
MAUDE report 20112775 ↗DeathAug 30, 2024Malposition of Device; Activation Failure; Malposition of Device; Activation Failure
IT WAS REPORTED THAT DURING FLOW DIVERSION OF LEFT POSTERIOR COMMUNICATING (PCOM) ANEURYSM, THE SUBJECT FLOW DIVERTER HAD A DIFFICULTY OPENING AT THE DISTAL SEGMENT. PHYSICIAN EXPLAINED A STENOSIS IN THE AREA OF CONCERN CAUSED BY A PREVIOUSLY PLACED NON-STRYKER FLOW DIVERTER DEVICE COULD HAVE RESULTED IN SUBJECT STENT OPENING DIFFICULTY. THE OPERATOR ATTEMPTED ANGIOPLASTY, BUT THE SUBJECT FLOW DIVERTER STILL DID NOT OPEN AND FLOW BEYOND SUBJECT STENT WAS LIMITED WHICH MAY HAVE CAUSED A STROKE. THE FLOW DIVERTER ONLY OPENED AFTER A THIRD ANGIOPLASTY WITH MORE PRESSURE. HOWEVER, THE VESSEL RUPTURED CAUSING CONTRAST EXTRAVASATION. AS A RESULT, THE PATIENT WAS DEEMED AS MEETING "BRAIN DEATH" CRITERIA AS THERE WAS NO DISTAL PERFUSION BEYOND THE INTERNAL CAROTID ARTERY (ICA). NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Perforation of Vessels; Stroke/CVA
MAUDE report 20107495 ↗InjuryMay 24, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL OF THE SUBJECT FLOW DIVERTER DID NOT OPEN AFTER DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE SUBJECT FLOW DIVERTER TO FULLY OPEN IT BUT WAS UNSUCCESSFUL AND THE SURGERY WAS STOPPED. THE FOLLOWING DAY, ANOTHER SURGERY WAS PERFORMED IN ATTEMPT TO FULLY OPEN THE SUBJECT FLOW DIVERTER BUT WAS UNSUCCESSFUL TO FULLY OPEN PROXIMALLY. THE PATIENT WAS PLACED ON MEDICATION AND IS CURRENTLY HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391669 ↗
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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