Stent FRED4518-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429106785), received between Nov 8, 2020 and Mar 19, 2021 — classified as 3 injuries, 1 malfunction.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A FRED STENT TO TREAT AN ANEURYSM OF THE LEFT SUPERIOR HYPOPHYSEAL ARTERY, THE PATIENT DEMONSTRATED SUDDEN ONSET OF APHASIA AND SEVERE RIGHT ARM AND LEG WEAKNESS. A CT SHOWED NO HEMORRHAGE AND CTA SHOWED AN ACUTE LEFT INTERNAL CAROTID ARTERY OCCLUSION. THE PATIENT WAS TAKEN FOR AN EMERGENT MECHANICAL THROMBECTOMY, WHICH WAS SUCCESSFUL. THE PATIENT'S SYMPTOMS RESOLVED SHORTLY THEREAFTER AND THEY WERE PRESCRIBED TICAGRELOR 90MG TWICE PER DAY. THE PATIENT REMAINS NEUROLOGICALLY INTACT FIVE MONTHS AFTER THE PROCEDURE.

  Patient problems: Muscle Weakness/Atrophy; Speech Disorder; Thrombosis/Thrombus

  MAUDE report 11522427 ↗
• MalfunctionFeb 11, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED, THE STENT DID NOT COMPLETELY OPEN AT THE PROXIMAL END. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319383 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE FRED TO TREAT A LEFT OPHTHALMIC ARTERY ANEURYSM, A FILLING DEFECT WAS NOTED AT THE PROXIMAL END OF THE STENT AND THE OPHTHALMIC ARTERY CLOSED DOWN. INTEGRILIN WAS GIVEN, WHICH RESTORED FLOW. SIX MONTHS POST-PROCEDURE, A FILLING DEFECT WAS STILL PRESENT AT THE PROXIMAL END OF THE STENT AND THE OPHTHALMIC ARTERY WAS CLOSED. THE PATIENT WAS REPORTED TO HAVE BLURRED VISION IN THE LEFT EYE. THERE WAS NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Blurred Vision; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 10844823 ↗
• InjuryNov 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED WAS SUCCESSFULLY IMPLANTED AS TREATMENT FOR A LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. POST-PROCEDURE, THROMBUS DEVELOPED INSIDE THE STENT. ASPIRATION THROMBECTOMY WAS PERFORMED AND INTEGRILIN WAS ADMINISTERED, WHICH COMPLETELY RESOLVED THE THROMBUS. THERE WAS NO SEQUELA.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10807086 ↗