Stent FREDX3513-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429114292), received between Dec 5, 2023 and Aug 28, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Stenosis” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Entrapment of Device; Retraction Problem; Stretched; Entrapment of Device; Retraction Problem; Stretched

  PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919391 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Device Stenosis; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE FRED X PAS STUDY THAT: "71% IN-STENT STENOSIS FOUND DURING A FOLLOW-UP ANGIOGRAM. THE PATIENT WILL REMAIN ON DUAL ANTIPLATELET THERAPY UNTIL NEXT ANGIOGRAM. THE PATIENT WAS ASYMPTOMATIC; NARROWING WAS NOT CLINICALLY SIGNIFICANT / FLOW LIMITING." EVENT START DATE: (B)(6)2024. RELATIONSHIP TO STUDY DEVICE: PROBABLE. RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE. RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED. RELATIONSHIP TO STUDY DISEASE: POSSIBLE. RELATIONSHIP TO CONCOMITANT DISEASE: POSSIBLE. AE OUTCOME: ONGOING.

  Patient problems: Paresthesia; Thrombosis/Thrombus

  MAUDE report 20539758 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FRED X PAS CLINICAL STUDY: PATIENT EXPERIENCED DIZZINESS AND PAIN BEHIND LEFT EYE. PATIENT DID NOT REPORT IT TO THE HOSPITAL PRIOR TO DISCHARGE. THE SEVERITY WAS CLASSIFIED AS MILD, AND THE EVENT WAS CLASSIFIED AS NOT A SERIOUS ADVERSE EVENT BY THE STUDY SITE. THE EVENT WAS RESOLVED TWO WEEKS LATER. A MONTH AFTER THE PATIENT EXPERIENCED DIZZINESS AND PAIN BEHIND LEFT EYE, PATIENT PRESENTS AS TRANSFER FROM ANOTHER ED AFTER PRESENTING WITH COMPLAINTS OF ACUTE ONSET HEADACHE AND BLURRY VISION OF LEFT EYE. PATIENT WAS HOSPITALIZED FOR A DAY. CT AND MRI WERE PERFORMED WITH NEGATIVE ACUTE FINDINGS AND NEGATIVE DEVICE MALFUNCTION FINDINGS. THE CT DID NOTE THAT THE PETROUS AND CAVERNOUS ICA ON THE LEFT IS SMALLER THAN THAT ON THE RIGHT AND SMALLER THAN THE CT EXAMINATION CONDUCTED THREE WEEKS AGO. IT WAS REPORTED BY THE CLINICAL STAFF THAT THERE IS A POSSIBLE RELATIONSHIP OF THE STUDY DEVICE TO THE REPORTED ADVERSE EVENT AS THE STENT WAS PLACED ON THE LEFT SUPRACLINOID AND PATIENT HAS HAD MULTIPLE LEFT SIDED HEADACHE EPISODES WITH PAIN BEHIND LEFT EYE REPORTED SINCE THE INDEX PROCEDURE. THE ADVERSE EVENT IS NOT RELATED TO THE PROCEDURE. PATIENT HAS A HISTORY OF SEVERE PO

  Patient problems: Blurred Vision; Headache

  MAUDE report 19326358 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL TRIAL, AUTO NOTIFICATION: STUDY: FRED X PAS. SITE: 01 --- (B)(6) UNIVERSITY. SUBJECT: (B)(6). ADDITIONAL INFORMATION: EVENT # : 1 EVENT TERM : LEFT- SIDED HEMIPLEGIA WITH GAZE DEVIATION. EVENT START DATE : 07-APR-2023. DATE SITE WAS MADE AWARE OF THE EVENT : 11-APR-2023. EVENT DESCRIPTION : POST PROCEDURE PATIENT HAD LEFT SIDED HEMIPLEGIA WITH GAZE DEVIATION. PATIENT WAS EMERGENTLY TAKEN FOR CT /CTA AND ANGIOGRAM. ANGIOGRAM SHOWED NO LARGE VESSEL OCCLUSION AND WAS NORMAL. PATIENT STARTED ON AGRASTAT INFUSION FOR 12 HOURS . SEVERITY : MODERATE WAS THIS A SERIOUS AE? : YES DATE AE WAS DETERMINED TO BE AN SAE : 11-APR-2023. MEDICATION : SPECIFY : AGRASTAT INFUSION FOR 12 HOURS. HOSPITALIZATION PROLONGED : HOSPITALIZATION ADMISSION DATE: (B)(6) 2023. HOSPITALIZATION DISCHARGE DATE : (B)(6) 2023. RELATIONSHIP TO STUDY DEVICE : CAUSAL RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE : CAUSAL RELATIONSHIP TO USE OF ANCILLARY DEVICE : NOT RELATED RELATIONSHIP TO STUDY DISEASE : NOT RELATED RELATIONSHIP TO CONCOMITANT DISEASE : NOT RELATED AE OUTCOME : RECOVERED/RESOLVED DATE OF RESOLUTION - RECOVERED/RESOLVED : (B)(6) 2023. DATE OF RESOLUTION - RECOV

  Patient problems: Paralysis; Unspecified Eye / Vision Problem

  MAUDE report 19146621 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE FRED X SOFAST CLINICAL TRIAL, THE FRED X27 FLOW DIVERTER WAS IMPLANTED AND ON 6 MONTHS FOLLOW-UP ANGIOGRAM, IT WAS FOUND THAT THE PATIENT HAD PERSISTENT FILLING OF THE RIGHT PCOM ANEURYSM. THE ADVERSE EVENT RESOLVED ON (B)(6), 2023 AFTER RETREATMENT. EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE, PROCEDURE AND TO THE DISEASE.

  Patient problems: Aneurysm

  MAUDE report 18270148 ↗