Stent FRED2520-PMARecalls & reported problems
Microvention, Inc. · FRED 21 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429106594), received between Jun 30, 2020 and Jan 2, 2024 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Neurological Deficit/Dysfunction1
- Thrombosis/Thrombus1
- Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FLOW DIVERTER STENT WAS DEPLOYED ACROSS AN ANEURYSM OF THE RIGHT PERICALLOSAL ARTERY. AFTER A FEW CONTRAST RUNS, CLOT FORMATION WAS NOTICED IN THE VESSEL. A STENT WAS IMPLANTED TO TACK DOWN THE CLOT FORMATION IN THE VESSEL. INTEGRELLIN WAS GIVEN TO DISSOLVE THE CLOT. THE PATIENT WAS REPORTED TO BE FINE.
Patient problems: Thrombosis/Thrombus
MAUDE report 18423474 ↗InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE FRED WAS SUCCESSFULLY IMPLANTED IN THE ANTERIOR CEREBRAL ARTERY (ACA) WITH NO RESHEATHING OR DEVICE MANIPULATIONS, AND THE FRED OPENED APPROPRIATELY. THE PATIENT HAD BEEN ANTICOAGULATED PRIOR TO THE PROCEDURE AND ANTICOAGULATION WAS MAINTAINED DURING THE CASE. THE PATIENT AWOKE POST-PROCEDURE WITH APHASIA AND RIGHT-SIDED WEAKNESS, AND APPROXIMATELY TWO (2) HOURS LATER WAS TAKEN BACK TO THE PROCEDURE ROOM. DSA IMAGING CONFIRMED ACA HYPOPERFUSION AND A COMPLETE OCCLUSION OF THE FRED. INTEGRILIN WAS ADMINISTERED, BUT WITHOUT SUCCESS; THEREFORE, ANOTHER STENT WAS IMPLANTED WITHIN THE FRED, WHICH RESULTED IN ONLY A MINIMAL IMPROVEMENT TO VESSEL PATENCY. THE PATIENT WAS REPORTED TO HAVE HAD A MAJOR STROKE AND IS DISABLED.
Patient problems: Neurological Deficit/Dysfunction; Thrombus
MAUDE report 10216039 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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