Surpass Evolve FDS32525Recalls & reported problems
Stryker Corporation · Flow Diverter System · Class 3 · Implant
All models of Surpass Evolve (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327375176), received between May 7, 2022 and May 7, 2022 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Confusion/ Disorientation1
- Hyperplasia1
- Movement Disorder1
- Stenosis1
- Stroke/CVA1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IN THE CLINICAL TRIAL THE SUBJECT FLOW DIVERTER WAS IMPLANTED IN A PATIENT ON (B)(6) 2021 AND WAS DISCHARGED ON (B)(6) 2021 WITH NO ISSUES. THE PATIENT WAS READMITTED ON (B)(6) 2021 WITH SIGNS AND SYMPTOMS OF STROKE WITH NIH OF 2 FOR RIGHT UPPER EXTREMITY (RUE) DRIFT AND CONFUSION. CT SHOWED STENT THROMBOSIS AND CT WAS POSITIVE FOR LEFT MCA INFARCT AND DSA DIAGNOSTIC/INTERVENTIONAL PROCEDURES PERFORMED SHOWED OCCLUDED STENT ON (B)(6) 2021. THROMBECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2021 FOR LEFT ICA (INTERNAL CAROTID ARTERY) INTRASTENT OCCLUSION AND LEFT ICA (INTERNAL CAROTID ARTERY) STENT PLACED (RE-STENTED AND ANGIOPLASTY). PATIENT HAD NIH 15 POST-OPERATION AND WAS PLACED ON IV INTEGRELLIN. THE PATIENT HAD NIH 2 FOR RUE AND RIGHT LOWER EXTREMITY (RLE) WITH DRIFT ON (B)(6) 2021 AND THE AE WAS NOTED TO BE RESOLVED/RECOVERED ON (B)(6) 2021. IT WAS NOTED THAT THE PATIENT HAD UNDERLYING COAGULATION PROBLEM NOT NOTED DURING SCREENING. THE PATIENT WAS HOSPITALIZED FOR SIX DAYS FROM (B)(6) 2021 DUE THE REPORTED AE. ON (B)(6) 2022 THE IMR (DESIGNATED CEC MEMBER) HAS ASSESSED STROKE IN THE PATIENT AS CAUSALLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO DUAL
Patient problems: Confusion/ Disorientation; Hyperplasia; Movement Disorder; Stenosis; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 14319834 ↗
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- PIPELINE PED-500-35Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death29 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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