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Stent FRED4513-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 00842429106778), received between Apr 2, 2020 and Aug 8, 2021 — 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

  1. 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

  • Muscle Weakness/Atrophy1
  • Stroke/CVA1
  • 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.

  • InjuryAug 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2021 A FRED STENT WAS SUCCESSFULLY IMPLANTED TO TREAT AN ANEURYSM OF ICA WITHOUT ISSUE. ON (B)(6) 2021, THE PATIENT RETURNED TO THE HOSPITAL WITH STROKE LIKE SYMPTOMS AND MEDICAL IMAGING SHOWED THAT THE STENT HAD FORMED THROMBUS ON IT AND HAD NO FLOW. NO ADJUNCT TREATMENT WAS ATTEMPTED AS IT WAS PAST THE 24-HOUR WINDOW. THE PATIENT HAS SOME LEFT SIDED WEAKNESS.

    Patient problems: Muscle Weakness/Atrophy; Stroke/CVA; Thrombosis/Thrombus

    MAUDE report 12292095 ↗
  • InjuryApr 2, 2020Activation Failure; Activation Failure

    IT WAS REPORTED THAT AFTER THE FRED WAS DEPLOYED IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA), IMAGING DEMONSTRATED OCCLUSION OF THE ICA. THROMBOLYTICS WERE ADMINISTERED AND THE ICA WAS REVASCULARIZED. DYNA CT WAS PERFORMED AND THE FRED DID NOT APPEAR TO BE FULLY OPENED AROUND THE TIGHTEST CURVATURE OF THE ICA. THE PATIENT AWOKE POST ANESTHESIA WITH NO DEFICIENCIES OR COMPLICATIONS. THE PATIENT IS CURRENTLY REPORTED TO BE IN SATISFACTORY CONDITION.

    Patient problems: Thrombus

    MAUDE report 9919230 ↗

Other Intracranial aneurysm flow diverter devices

All Intracranial aneurysm flow diverter devices →

Sources and updates

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