Stent FRED4026-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429106747), received between Apr 8, 2020 and Mar 27, 2021 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A 20MM RUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY (ICA) AND A SHUNT WAS PLACED. A FRED STENT WAS IMPLANTED INTO THE ICA ACROSS THE ANEURYSM THE NEXT DAY. THE PATIENT WAS NOTED TO HAVE DELAYED FLOW AND VASOSPASM POST PROCEDURE. THE PATENCY AND APPOSITION OF THE FRED NEAR THE MIDDLE PORTION OF THE STENT WAS UNCLEAR, BUT IT WAS CONFIRMED THAT THE FRED WAS FULLY OPEN PROXIMAL AND DISTAL TO THAT LOCATION. IT APPEARED THAT A CLOT WAS FORMING OUTSIDE OF THE FRED STENT AND THE PHYSICIAN ADMINISTERED VERAPAMIL, WHICH IMPROVED FLOW. NUMEROUS AND PROLONGED ATTEMPTS WERE MADE TO INCREASE THE PATIENT'S BLOOD PRESSURE AND BLOOD FLOW. UPON REMOVAL OF THE GUIDE CATHETER, THE PHYSICIAN NOTICED THAT BLOOD FLOW TO THE ICA WAS RESTRICTED DUE TO VASOSPASM IN THE FEMORAL ARTERY. THE PHYSICIAN RESOLVED WITH PRESSURE RATHER THAN USE OF A CLOSURE DEVICE. THE PATIENT APPARENTLY SUFFERED A STROKE THE NEXT DAY, THE LOCATION AND CAUSE OF WHICH IS UNKNOWN, AND LATER PASSED AWAY. BASED ON REPORTED INFORMATION, THERE IS NO INDICATION THAT THE DESIGN OR FUNCTION OF THE FRED CONTRIBUTED TO THE WELL-RECOGNIZED COMPLICATIONS. HOWEVER, THE INDICATIO

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11579528 ↗
• InjuryApr 8, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A LEFT OPHTHALMIC INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THERE WAS SIGNIFICANT VESSEL DIAMETER DISCREPANCY AND VESSEL TORTUOSITY THROUGHOUT THE PETROUS AND CAVERNOUS ICA. THE FRED WAS DEPLOYED AROUND THE CAROTID SIPHON. THE DISTAL AND MIDDLE SECTIONS OF THE DEVICE OPENED WELL; HOWEVER, THE PROXIMAL END DID NOT OPEN AFTER DEPLOYMENT. ATTEMPTS TO OPEN THE PROXIMAL END OF THE FRED WITH THE DELIVERY WIRE, THE MICROCATHETER, AND THE GUIDE CATHETER WERE UNSUCCESSFUL. DURING THE ATTEMPT TO RETRIEVE THE STENT WITH A GOOSENECK SNARE, THE PROXIMAL FINISHED ENDS WERE PUSHED FORWARD INTO THE OPEN SECTION OF THE FRED. SUBSEQUENT ANGIOGRAPHIC IMAGES DEMONSTRATED A PATENT FRED AND ROBUST FLOW THROUGH THE DEVICE. THERE WAS NO EVIDENCE OF THROMBUS. THE DEVICE WAS LEFT IMPLANTED AT THE INTENDED TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941824 ↗