Stent FREDX3531-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
- 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 00842429114322), received between Aug 22, 2024 and Aug 22, 2024 — 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
- Muscle Weakness/Atrophy1
- 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.
InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, "ICA OPTHALMIC ANEURYSM TO BE TREATED WITH A FREDX DEVICE. DEPLOYED FROM ICA TERMINUS, ACROSS THE NEXT OF ANEURYSM AND INTO THE CAVERNOUS ICA. STENOTIC AREA OF VESSEL/FREDX NEAR THE PROXIMAL NECK OF ANEURYSM PROXIMAL TO THE OPTHALMIC ARTERY. A 4X10 SEPTER BALLOON WAS USED TO DILATE, BUT DID NOT INCREASE DIAMETER OF STENOTIC AREA. FINAL IMAGES WERE OBTAINED WITH GOOD FLOW THROUGH AND DISTAL OF THE IMPLANT. PATIENT WAS WOKE FROM ANASTESHIA WITH HEMIPARALYSIS, WAS PUT BACK ON THE TABLE TO FIND THE OCCLUSIVE THROMBUS NEAR STENOTIC PORTION. A TENZIG CATHETER WAS SENT INTO THE M1 AND A FREE CLIMB ASPIRATION CATHETER WAS BROUGHT UP TO THE ORIGIN OF THE CLOT. ONE SEGMENT OF ASPIRATION WAS PERFORMED. UPON IMAGING POST ASPIRATION BLEEDING WAS OBSERVED. A BALLOON WAS DELIVERED TO TAMPONADE THE BLEED, AND 7 COILS WERE THEN IMPLANTED IN THROUGH THE ICA DOWN PAST THE OPTHALMIC TO SACRIFICE THE VESSEL AND STOP THE BLEEDING. THIS WAS BELIEVED TO BE DUE TO A STENOTIC VESSEL. THE PATIENT IS ALIVE AND HAD A LARGE L MCA STROKE. HAD TO DO DECOMPRESSIVE CRANIECTOMY AND WILL HAVE RIGHT SIDED HEMIPLEGIA AND SPEECH DEFICITS/APHASIA.THE PATIENT IS ALIVE AND HAD A LARGE L MCA STROKE. HAD TO
Patient problems: Muscle Weakness/Atrophy; Stroke/CVA; Thrombosis/Thrombus
MAUDE report 20028323 ↗
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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