Stent FREDX4534-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 00842429114421), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Activation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Activation Problem
IT WAS REPORTED FOR A PATIENT ENROLLED IN THE CAR (COMPLEX ANEURYSM REGISTRY) STUDY THAT A SEGMENT OF A FREDX DEVICE DID NOT COMPLETELY OPEN DURING PROCEDURE. A NON-RUPTURED, RIGHT MCA BIFURCATION ANEURYSM WAS TREATED WITH A FREDX DEVICE. THE SPONSOR REVIEW OF INDEX PROCEDURE NOTE IDENTIFIED A SEGMENT OF A FREDX DEVICE DID NOT COMPLETELY OPEN DURING PROCEDURE. AT THIS TIME, THE FRED-X DELIVERY SYSTEM WAS TAKEN THROUGH THE MICROCATHETER. THE DEVICE WAS DEPLOYED WITH THE DISTAL LANDING ZONE NEAR THE OPHTHALMIC ARTERY AND THE PROXIMAL LANDING JUST PROXIMAL TO THE HORIZONTAL PETROUS SEGMENT. THERE WAS GOOD WALL APPOSITION OF THE DEVICE ON INTERMITTENT ANGIOGRAPHY PROXIMALLY AND DISTALLY OUT BUT THERE WAS A SEGMENT THAT DIDN'T APPEAR TO OPEN FULLY ACROSS THE PROXIMAL PORTION OF THE ANEURYSM NECK. FOR THIS REASON, WE DECIDED TO ANGIOPLASTY THE DEVICE. THE MICROCATHETER WAS TAKEN BACK OVER THE DELIVERY WIRE THROUGH THE PROXIMAL 2/3'S OF THE STENT FOLLOWED BY COMPLETE WITHDRAWAL OF THE DELIVERY WIRE. THE GUIDEWIRE WAS THEN INSERTED THROUGH THE MICROCATHETER AND ADVANCED OUT OF THE FLOW DIVERTING STENT AND INTO THE RIGHT M1. THE MICROCATHETER WAS EXCHANGED OFF FOR THE BALLOON. THE BALLOON W
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715745 ↗
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