Stent FRED5014-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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429106822), received between Oct 15, 2020 and Dec 5, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Activation Failure” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jun 7, 2023Open, Classified
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
Z-2238-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Failure1
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Obstruction/Occlusion1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING TREATMENT OF A RIGHT SUPERIOR HYPOPHYSEAL ARTERY ANEURYSM, TWO FRED STENTS WERE DEPLOYED WITH GOOD WALL APPOSITION IN THE RIGHT INTERNAL CAROTID ARTERY (RICA); HOWEVER, THE RICA BECAME OCCLUDED SHORTLY AFTER IMPLANTATION. INTEGRILIN WAS ADMINISTERED AND A BALLOON INFLATION WAS PERFORMED WITHIN THE STENTS, WHICH COMPLETELY RECANALIZED THE RICA AND FULLY RESTORED BLOOD FLOW. THE PATIENT WAS NEUROLOGICALLY INTACT AND DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY.
Patient problems: Thrombosis/Thrombus
MAUDE report 10953337 ↗InjuryOct 15, 2020Activation Failure; Activation Failure
IT WAS REPORTED THAT UPON DEPLOYMENT OF THE FRED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), THE STENT WAS NOT FULLY OPENED. THE ANTERIOR CEREBRAL ARTERY (ACA) AND THE ICA SHUT DOWN. A BALLOON WAS INFLATED WITHIN THE STENT, WHICH FULLY OPENED THE STENT AND RESTORED FLOW TO THE ACA AND ICA.
Patient problems: Obstruction/Occlusion
MAUDE report 10688083 ↗
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 · each recall links to the FDA recall notice
- 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