Stent FREDX4013-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429114346), received between Jan 6, 2025 and Feb 3, 2026 — classified as 1 death, 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. Sep 5, 2025Open, Classified

   Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

   Z-0108-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED PROVIDED THE DEVICE MODEL & LOT NUMBER AND INDICATED: ORIGINAL SURGICAL DATE / STUDY PROCEDURE WAS ON (B)(6) 2024. CORELAB REPORTED THE 40% IN-STENT STENOSIS AT THE 6-MONTH FU IMAGING AND THE CLINICAL SITE REPORTED 90% TARGET ANEURYSM OCCLUSION AT THE 6-MONTH FU IMAGING ALL PERFORMED ON (B)(6) 2024. THE CLINICAL SITE REPORTED 20% TARGET ANEURYSM OCCLUSION AT THE 1-YR FU IMAGING PERFORMED ON (B)(6) 2025. RECANALIZATION HAS NOT BEEN CONFIRMED. NO TREATMENT WAS REQUIRED FOR THE 40% IN-STENT STENOSIS. NO TREATMENT WAS ADMINISTERED FOR AE IN-STENT STENOSIS/INTIMAL HYPERPLASIA OR VITREOUS FLOATERS OF BOTH EYES. TO DATE, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 24254521 ↗
• DeathOct 15, 2025Difficult or Delayed Positioning; Unintended Movement; Activation Failure; Difficult or Delayed Positioning; Unintended Movement; Activation Failure

  NO FURTHER INCIDENT INFORMATION WAS RECEIVED, HOWEVER REVIEW OF RECEIVED IMAGES IS COMPLETED. PLEASE SEE H6 AND H11.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 23287227 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY, THE SUBJECT REPORTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF WORSENING LEFT UPPER EXTREMITY WEAKNESS AND NUMBNESS. IMAGING WAS PERFORMED THAT WAS NEGATIVE FOR STROKE AND POSITIVE FOR MICROEMBOLIC SIGNAL (MES). MES WAS INCIDENTAL FINDING AND TOO SMALL TO CAUSE THE INDICATED SYMPTOMS. THE SUBJECT WAS RE-STARTED ON DAPT. THE SUBJECT WAS DISCHARGED THE NEXT DAY. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE FLOW DIVERTER STENT DEVICE, WHICH WAS ORIGINALLY IMPLANTED ON (B)(6) 2023. THE ADVERSE EVENT IS ONGOING AND NO FURTHER UPDATES AVAILABLE AT THIS TIME.

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 21087886 ↗