Stent FRED3536-PMARecalls & reported problems
Microvention, Inc. · FRED 27 · Class 3 · Implant
All models of Stent (63)
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 00842429106693), received between Sep 4, 2020 and Sep 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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
- Difficult or Delayed Activation1
Patient problems
- Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2020Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT THE FRED WAS USED AS TREATMENT FOR A TORTUOUS M2 TO M1 FUSIFORM ANEURYSM WITH TWO CURVES. THE FRED WAS DELIVERED SMOOTHLY; HOWEVER, THE PROXIMAL STENT DID NOT COMPLETELY OPEN UPON DEPLOYMENT. THROMBUS FORMATION WAS OBSERVED INSIDE THE PROXIMAL PORTION OF THE FRED. INTEGRILIN WAS ADMINISTERED THROUGH THE MICROCATHETER AT THE PROXIMAL PORTION OF THE DEVICE. ASPIRATION WAS ATTEMPTED, BUT WAS NOT SUCCESSFUL. AFTER MULTIPLE MANIPULATIONS OF THE DEVICE WITH THE MICROCATHETER AND MICROWIRE, THE FRED COMPLETELY OPENED AND THE THROMBUS WITHIN THE DEVICE WAS NO LONGER VISUALIZED. NO NEUROLOGICAL DEFICITS OR ABNORMALITIES WERE OBSERVED DURING THE POST-PROCEDURE NEUROLOGICAL EXAM OF THE PATIENT. THE PATIENT IS CURRENTLY REPORTED TO BE DOING WELL.
Patient problems: Thrombus
MAUDE report 10495426 ↗
Other Intracranial aneurysm flow diverter devices
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- 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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