Stent FRED3524-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429106686), received between Jul 10, 2020 and Jul 10, 2020 — classified as 1 injury.

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

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED THROMBUS WITHIN THE FRED STENT AFTER IMPLANTATION IN THE MIDDLE CEREBRAL ARTERY (MCA). A SLIGHT STENOSIS WAS PRESENT IN THE MCA PRIOR TO THE PROCEDURE. THERE WERE NO COMPLICATIONS DURING DEPLOYMENT OF THE FRED. A BOLUS AND INFUSION OF AGGRASTAT AND A BOLUS DOSE OF CANGRELOR WAS ADMINISTERED DURING THE PROCEDURE, WHICH WAS SUCCESSFUL AT INCREASING VESSEL PATENCY, AND THE PATIENT WAS MAINTAINED ON AN AGGRASTAT INFUSION DRIP FOR 18 HOURS POST-PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL "INTACT." THERE WAS NO REPORTED SEQUELA.

  Patient problems: Thrombus

  MAUDE report 10259428 ↗