Stent FRED5029-PMARecalls & reported problems
Microvention, Inc. · FRED 27 · Class 3 · Implant
Data updated Oct 13, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429106846), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Difficult to Remove1
- Malposition of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2020Difficult to Remove; Malposition of Device; Difficult to Remove; Malposition of Device
IT WAS REPORTED THAT TREATMENT WAS ATTEMPTED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. THE PATIENT'S ANATOMY WAS REPORTED TO BE VERY TORTUOUS. THE PROXIMAL FINISHED ENDS OF THE FRED WERE DEPLOYED AT THE NECK OF THE ANEURYSM. AN ATTEMPT WAS MADE TO RE-ACCESS THE PROXIMAL END OF THE DEVICE WITH A MICROCATHETER AND THE FRED WAS PUSHED INTO THE ANEURYSM SAC. MULTIPLE ATTEMPTS WERE THEN MADE TO REMOVE THE FRED USING A GUIDE WIRE AND A SNARE DEVICE, INCLUDING ACCESSING THE CONTRALATERAL FEMORAL ARTERY TO REACH THE FRED THROUGH THE ACOM ARTERY. ALL ATTEMPTS WERE UNSUCCESSFUL AND THE FRED WAS LEFT IMPLANTED IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311955 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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