Surpass Elite FDSE45030Recalls & reported problems
Stryker Corporation · Flow Diverter System · Class 3 · Implant
All models of Surpass Elite (17)
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 07613327582932), received between Mar 6, 2026 and Mar 6, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Obstruction/Occlusion1
- Speech Disorder1
- 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.
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 ↗
Other Intracranial aneurysm flow diverter devices
- Pipeline TM Flex Embolization Device with Shield Technology TM PED2-300-12Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter2 recalls1 report
- PIPELINE PED-500-20Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall31 reports
- PIPELINE PED-500-35Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death29 reports
- PIPELINE PED-500-16Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall2 deaths27 reports
- PIPELINE PED-500-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death23 reports
- PIPELINE PED-500-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall21 reports
- PIPELINE PED-450-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall20 reports
- PIPELINE PED-475-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death19 reports
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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