Stent FREDX5036-PMARecalls & reported problems
Microvention, Inc. · FRED-X 27 · Class 3 · Implant
All models of Stent (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429114476), received between Oct 1, 2022 and Apr 24, 2024 — classified as 1 death, 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 Problem2
Patient problems
- Intracranial Hemorrhage1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: ¿A [FLOW DIVERTER] WAS DEPLOYED ACROSS CERVICAL ANEURYSM 11MM. IT WAS REPOSITIONED AND RESHEATHED TO GET [THE FLOW DIVERTER] TO OPEN COMPLETELY. THE [FLOW DIVERTER] WAS DEPLOYED. CONTRASTY RUNS TAKEN. POST PROCEDURE THE PATIENT WAS FINE, AND THE NEXT MID-MORNING AD DEVELOPED AN M4 OCCLUSION-MEDS WERE GIVEN THROMBOLYTIC, AND PATIENT HAD A HEMORRHAGE.¿ TENECTEPLASE WAS USED AS INTERVENTION. ¿PATIENT PASSED AWAY.¿ THE OFFICIAL CAUSE OF DEATH WAS HEMORRHAGE, ¿THE FAMILY DIDN¿T WANT A HEMI CRANI.¿ THE DATE OF DEATH WAS REQUESTED AS WELL AND NOT FORTHCOMING.
Patient problems: Intracranial Hemorrhage
MAUDE report 19177513 ↗InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT EIGHT DAYS POST-IMPLANTATION OF A FLOW DIVERTER, THE PATIENT PRESENTED TO THE ER WITH STROKE SYMPTOMS. THROMBOSIS WAS OBSERVED IN THE ICA TREATMENT SITE. CATHETER ASPIRATION WAS PERFORMED TO TREAT THE PATIENT IN ORDER TO ADDRESS THE SYMPTOMS. THE PHYSICIAN DETERMINED THAT THE PATIENT DID NOT TAKE THE PRESCRIBED PLAVIX MEDICATION POST-IMPLANTATION OF THE FLOW DIVERTER. THE PATIENT IS IN STABLE CONDITION.
Patient problems: Thrombosis/Thrombus
MAUDE report 15523941 ↗
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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