Stent FRED4012-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842429106723), received between Aug 21, 2020 and Jun 25, 2021 — classified as 1 death, 5 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A FRED STENT WAS IMPLANTED IN A PATIENT, THE INTERNAL CAROTED ARTERY (ICA) CLOTTED OFF JUST PROXIMAL TO THE FRED STENT. THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS AND APHASIA. THE PATIENT WAS BROUGHT BACK FOR IA DRUG THERAPY AND CLOT REMOVAL; HOWEVER, SYMPTOMS OF APHASIA AND HEMIPARESIS PERSISTED. THE PATIENT UNDERWENT ICA BYPASS SURGERY TO RESTORE FLOW BEYOND THE FRED STENT. REPORTEDLY, CEREBRAL INFARCTION WAS NOTED ON RECENT CT SCAN.

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

  MAUDE report 12072123 ↗
• MalfunctionJan 14, 2021Activation Failure

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED, THE PROXIMAL END OF THE STENT APPEARED TO BE SLIGHTLY MALAPPOSED TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11175569 ↗
• InjuryDec 22, 2020Migration; Migration

  IT WAS REPORTED THAT A FEW DAYS POST-PROCEDURE IN WHICH THE FRED WAS IMPLANTED TO TREAT AN OPHTHALMIC ARTERY ANEURYSM, THE FRED WAS NOTED TO HAVE MIGRATED UP TO THE M1 SEGMENT. NO INTERVENTION WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 11058580 ↗
• MalfunctionOct 30, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER THE FRED WAS SUCCESSFULLY DEPLOYED, THE DELIVERY WIRE CAUGHT ON THE STENT DURING RETRACTION. THE DELIVERY WIRE EVENTUALLY RELEASED FROM THE STENT WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10766764 ↗
• InjuryOct 23, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN OPHTHALMIC ANEURYSM IN A CALCIFIED VESSEL. UPON DEPLOYMENT, THE PROXIMAL END OF THE FRED WAS NOT COMPLETELY APPOSED TO THE VESSEL WALL. THERE WAS NO FLOW LIMITATION. INTEGRILIN WAS ADMINISTERED TO THE PATIENT. THE PROXIMAL FRED WAS COMPLETELY OPENED WITH A BALLOON. THERE WAS NO SEQUELA. THE PATIENT IS CURRENTLY REPORTED TO BE NEUROLOGICALLY INTACT AND DOING GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731603 ↗
• DeathOct 23, 2020Migration; Migration

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. AFTER THE FRED WAS IMPLANTED IN THE ICA, THE FRED AND THE ICA BECAME TOTALLY OCCLUDED WITH CLOT. THERE WAS NO FLOW TO THE PATIENT'S LEFT CEREBRAL HEMISPHERE. THE FRED MIGRATED AND THE ANEURYSM WAS LEFT OPEN TO BLOOD FLOW. THE NEXT DAY, THE ANEURYSM WAS EMBOLIZED WITH COILS. THE PATIENT DIED SOMETIME LATER; HOWEVER, THE DATE AND CAUSE OF DEATH IS UNKNOWN. THE RELATIONSHIP OF THE FRED TO THE DEATH IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10731592 ↗
• InjuryOct 19, 2020Retraction Problem; Unintended Movement; Retraction Problem; Unintended Movement

  IT WAS REPORTED THAT THE FRED WAS USED TO TREAT AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. AFTER DEPLOYMENT OF THE FRED, THE DELIVERY WIRE CAUGHT ON THE STENT AND MOVED THE STENT PROXIMALLY DURING THE REMOVAL ATTEMPT. THE DELIVERY WIRE RELEASED FROM THE STENT AND ANOTHER FRED WAS IMPLANTED WITHIN THE FIRST FRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10702517 ↗
• InjuryAug 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE FRED WAS DEPLOYED WITHOUT INCIDENT IN THE INTERNAL CAROTID ARTERY (ICA). POST-DEPLOYMENT, THROMBUS DEVELOPED ON THE PROXIMAL PORTION OF THE FRED AND THE ICA BECAME OCCLUDED. INTEGRILIN WAS ADMINISTERED INTRA-ARTERIALLY AND THE ICA OPENED UP. IT APPEARED THAT THE INNER STENT OF THE FRED WAS SEPARATED FROM THE OUTER STENT. THE STENT WAS OPENED AND THE PATIENT WOKE UP NEUROLOGICALLY INTACT. THERE WAS NO REPORTED SEQUELA.

  Patient problems: Thrombus

  MAUDE report 10439817 ↗