Stent FREDX3517-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429114308), received between Feb 14, 2023 and Mar 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY: ANEURYSM OCCLUSION DECREASED FROM 90% AT 6 MONTH TO 85% AT 12 MONTH. EVENT TERM : WORSENING IN OCCLUSION DATE SITE WAS MADE AWARE OF THE EVENT : 11-APR-2025 RELATIONSHIP TO DEVICE: POSSIBLE RELATIONSHIP TO PROCEDURE: NOT RELATED NO TREATMENT PERFORMED FOT THE ANEURYSM. NO ADDITIONAL AES. PT IS ASYMPTOMATIC. RETREATMENT HAS NOT BEEN SCHEDULED OR PERFORMED YET.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24737038 ↗
• InjuryFeb 14, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED A SUBARACHNOID HEMORRHAGE, RETROPERITONEAL AND DISSECTING ANEURYSMS OF THE ACA. DUE TO THE EXPANDING DISSECTING ANEURYSM ALONG THE RIGHT ACA-A1 SEGMENT WITH AN ADDITIONAL DISSECTING ANEURYSM OF THE DISTAL LEFT VERTEBRAL ARTERY ANEURYSM, TREATMENT WAS PLANNED. THUS, THE PATIENT HAD A REVISION OF THE EXTERNAL VENTRICULAR DRAIN. AN INITIAL ATTEMPT AT FLOW DIVERTER PLACEMENT FAILED SECONDARY TO THE CATHETER PULLED OUT OF POSITION. THE FLOW DIVERTER WAS WITHDRAWN, RE-SHEATHED AND REMOVED WITHOUT A PROBLEM. THE MICROCATHETER WAS AGAIN REPOSITIONED INTO THE R.A2 SEGMENT AND A SECOND FLOW DIVERTER (LONGER DEVICE) WAS ADVANCED INTO POSITION AND WAS PLACED IN THE PROXIMAL SEGMENT OF THE A1 AND DETACHED. AN INITIAL CONTROL ANGIOGRAM DEMONSTRATED THAT THE FLOW DIVERTER WAS WELL OPPOSED TO THE PARENT ACA WITH FLOW INTO THE OUTFLOW A2 VESSEL. UPON THE 5- AND 15-MIN DELAYED IMAGING, THE IMAGING INDICATED THAT THE FLOW DIVERTER APPEARED TO HAVE CLOT IN THE DISTAL SEGMENT OF THE DEVICE WITH DECREASED FLOW INTO THE OUTFLOW VESSELS WITH CONTINUED RETROGRADE OCCLUSION. VASOSPASM IN THE A2 DISTAL VESSEL WAS OBSERVED. INTEGRILIN AND VERAPAMIL WERE ADMINISTERED,

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16373168 ↗