Surpass Streamline M003SFD040400Recalls & reported problems
Stryker Corporation · Flow Diverter · Class 3 · Implant
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 07613252648802), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Failure” (1 report).
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
- Activation Failure1
Patient problems
- Neurological Deficit/Dysfunction1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2019Activation Failure; Activation Failure
IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A STENT FLOW DIVERTER (SUBJECT DEVICE). THE SUBJECT STENT WAS IMPLANTED OVER THE OPTHALMIC ARTERY BUT IT DID NOT OPPOSE THE PARENT VESSEL WALL COMPLETELY. ANGIOPLASTY WAS PERFORMED DUE TO THE STENT MALPOSITION. 6 HOURS POST PROCEDURE, THE PATIENT DEVELOPED AN EYE STROKE AND THE PATIENT VISION IS NOW CLOUDY. ACCORDING TO THE PHYSICIAN, THE EYE STROKE AND PATIENT¿S CLOUDY VISION WERE CAUSED BY USING THE BALLOON TO ANGIOPLASTY TO STENT (SUBJECT DEVICE). NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA
MAUDE report 8889390 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page