Stent FRED4508-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429106761), received between Sep 30, 2020 and Dec 9, 2021 — classified as 5 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED DEVICE CLOTTED OFF AT 1 YEAR FOLLOW-UP. INDEX PROCEDURE DESCRIBED AS NORMAL, SINGLE DEPLOYMENT OF THE STENT WITH NO RECAPTURE OF STENT REQUIRED. THE PATIENT'S P2Y12 WAS IN RANGE DURING THE PROCEDURE AND THE PHYSICIAN HAD THE PATIENT ON DAPT PROTOCOL POST PROCEDURE. PATIENT CURRENTLY STILL ON DAPT. THERE IS NO FOLLOW UP TREATMENT PLANNED AT THIS TIME. AT THE TIME OF THIS REPORT THE PATIENT IS DOING WELL AND HAVE CROSS FILL THROUGH THE ANTERIOR COMMUNICATING ARTERY (ACOM).

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 12971016 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED STENT WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) FOR RETREATMENT OF AN ANEURYSM THAT WAS COILED APPROXIMATELY 6 MONTHS AGO FOR AN ACUTE RUPTURE AND HAD A NECK REMAINING. POST DEPLOYMENT, THE PATIENT WOKE UP WITH LEFT SIDED WEAKNESS. ANOTHER ANGIO WAS PERFORMED THAT IDENTIFIED WHAT APPEARED TO BE A CLOT IN THE LUMEN OF THE FRED DEVICE. ATTEMPTS WERE MADE TO ASPIRATE THE CLOT AND REMOVE THE FRED DEVICE USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. REPORTEDLY, THE PATIENT SUFFERED LARGE HYPOXIC INJURY OF GREY MATTER.

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

  MAUDE report 11932233 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED STENT WAS IMPLANTED TO TREAT A SUPRACLINOID WIDE NECK ANEURYSM. IMMEDIATE POST IMPLANTATION IMAGING SHOWED GOOD WALL APPOSITION, ANEURYSM STATUS, AND GOOD PERFUSION. THREE MINUTES LATER, A SECOND ANGIO RUN WAS PERFORMED AND THERE WAS COMPLETE OCCLUSION OF FRED WITH NO DISTAL PERFUSION AND THE DEVICE APPEARED TO HAVE THROMBUS AFFIXED TO IT. AFTER TAKING ADDITIONAL SPOT FLUORO IMAGES, THE DEVICE DID NOT APPEAR FULLY OPEN, IT HAD FORESHORTENED, AND IT HAD ALSO MIGRATED PROXIMALLY. AGGRASTAT IA WAS ADMINISTERED AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TWICE. A SECOND FRED STENT WAS IMPLANTED SINCE THE FIRST STENT WAS NO LONGER COVERING THE ANEURYSM. ANGIO SHOWED GOOD WALL APPOSITION AND REPERFUSION, BUT THROMBUS CONTINUED TO FORM. FURTHER MEDICATION WAS ADMINISTERED AND PTA WAS PERFORMED, BUT CLOT CONTINUED TO FORM. THE PHYSICIAN REPEATED PTA MULTIPLE TIMES AND AFTER WAITING 15 MINUTES, PATIENT HAD ADEQUATE FLOW. THE PHYSICIAN DECIDED TO STOP THE CASE AND SEE HOW THE PATIENT WOKE UP. POST ANESTHESIA, THE PATIENT WOKE UP MOVING ALL EXTREMITIES AND WAS ABLE TO SPEAK. THIS REPORT REFERS TO THE SECOND STENT IMPLANTED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11904861 ↗
• InjuryMay 25, 2021Migration; Migration

  IT WAS REPORTED THAT A FRED 27 STENT WAS PLACED FOR THE TREATMENT OF AN UNRUPTURED ANTERIOR CHOROIDAL ANEURYSM. THE FRED STENT WAS DEPLOYED SUCCESSFULLY AND WITH GOOD NECK COVERAGE. THE PHYSICIAN WAS ADVISED TO USE A LONGER STENT; HOWEVER, ELECTED TO USE A SHORT ONE. AT 6 MONTHS ANGIOGRAPHIC FOLLOW-UP RUN, THE FRED WAS OBSERVED TO BE COMPACTED BACK PAST THE NECK OF THE ANURYSM. THE PATIENT WAS DISCHARGED THE SAME DAY AFTER FOLLOW-UP ANGIOGRAM. THE PHYSICIAN STATED THAT THEY WILL RETREAT THE ANEURYSM WITH ANOTHER FLOW DIVERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882103 ↗
• InjurySep 30, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT UPON DEPLOYMENT OF THE FRED IN THE INTERNAL CAROTID ARTERY, THE DEVICE WAS PARTIALLY EXPANDED. THE STENT WAS COMPLETELY EXPANDED WITH ADDITIONAL GUIDE WIRE MANIPULATIONS. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS CURRENTLY REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10607447 ↗