Stent FREDX4023-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00842429114360), received between May 25, 2022 and Mar 16, 2026 — classified as 1 death, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FLOW DIVERTER STENT WAS USED TO TREAT A PATIENT WITH MALFORMATION IN PROXIMAL ICA MEASURING 3.0MM DISTAL, AND 3.52MM PROXIMAL. THE PATIENT STAYED IN THE HOSPITAL FOR FOUR DAYS DUE TO HEADACHE, WHEN DISCHARGED ON (B)(6) 2026. REPORTEDLY, FIVE DAYS POST DISCHARGE - THE PATIENT CAME BACK WITH HEADACHE AND LEFT SIDE WEAKNESS. DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED AND THROMBECTOMY WAS ATTEMPTED ON (B)(6), 2026 BUT FAILED AS IT "COULD NOT GET THROUGH WITH WIRE." BREILENTA P2612 - 14 AND P2Y12 - 55 TRIPLE THERAPY WAS ADMINISTERED AND THE CASE COMPLETED SUCCESSFULLY. PATIENT OUTCOME REPORTED AS "TRIPLE THERAPY WITH NO COMPLICATIONS."

  Patient problems: Headache; Muscle Weakness/Atrophy

  MAUDE report 24610312 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY THAT A PATIENT ENROLLED IN THE FRED X PAS CLINICAL STUDY EXPERIENCED FACIAL NUMBNESS ON POD 82, WHICH WAS CEC ADJUDICATED AS HAVING A ¿POSSIBLE¿ RELATIONSHIP TO FREDX DEVICE. THE SUBJECT PRESENTED TO ER DUE TO LEFT FACIAL NUMBNESS THAT STARTED WHILE PLAYING SOCCER. THE AE WAS NOT CAUSED BY A TECHNICAL EVENT. THE EVENT RESOLVED ON THE SAME DAY, WITHOUT THE NEED FOR INTERVENTION OR ADDITIONAL ACTION. THE PT REPORTED NON-COMPLIANCE TO TAKING DAILY CLOPIDOGREL AND WAS ADVISED TO TAKE IT DAILY. IMAGING DID NOT REPORT ANY ABNORMAL FINDINGS. NO FURTHER ACTION OR INTERVENTION WAS TAKEN.

  Patient problems: Numbness

  MAUDE report 24309653 ↗
• MalfunctionSep 15, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED THROUGH THE FRED X PAS STUDY. REGARDING SUBJECT FREDX-17-002, THE CORELAB REPORTED FREDX PROXIMAL FORESHORTENING AT THE 6M FU IMAGING PERFORMED ON (B)(6)2024. ADDITIONAL INFORMATION INDICATED: DATE OF INITIAL TREATMENT (B)(6)2024. PT CONDITION: MRS REMAINS 0 AT 6M AND 1YR FU VISITS ON (B)(6)2024 AND (B)(6)2025. ADDITIONAL INFORMATION INDICATED: ANEURYSM FULLY OCCLUDED AT 6M AND12M FOLLOW-UP. THE NECK OF THE ANEURYSM IS COVERED BY THE FLOW DIVERTER. NO ADDITIONAL TREATMENT OR INTERVENTION WAS PLANNED. THE PATIENT IS ASYMPTOMATIC. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059764 ↗
• MalfunctionAug 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THROUGH A FREDX CLINICAL STUDY, A FLOW DIVERTER STENT WAS USED TO TREAT THE PATIENT. DURING A FOLLOW UP VISIT SIX MONTHS LATER, AN IMAGE WAS TAKEN WHICH SHOWED PROXIMAL FORESHORTENING OF THE STENT. THE STENT WAS ALIGNED WITH VESSEL FOR BETTER ACCESS. THE EXACT PERCENTAGE OF FORESHORTENING SEEN FROM THE INDEX PROCEDURE IS NOT KNOWN. THE PATIENT WAS NOT INJURED. THERE WAS NO SURGICAL INTERVENTION OR OTHER TREATMENT NEEDED. THE PATIENT¿S OUTCOME WAS REPORTED AS MRS SCORE OF 0 AT THE 6 MONTH AND 1YEAR FOLLOW UP VISIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926263 ↗
• InjuryJun 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, "THE FRED-X DEVICE WAS DELIVERED WITHOUT ISSUE. THE POSITIONING WAS IDEAL AND THERE WERE NO APPARENT ISSUES DURING IMPLANT. WHEN THE PATIENT WAS AWAKENED, IT WAS APPARENT THAT SOME MILD STOKE SYMPTOMS HAD DEVELOPED. IT WAS THEN DECIDED TO GO BACK IN AND COMPLETE A DIAGNOSTIC ANGIO TO DETERMINE IF ANY ISCHEMIC ISSUES HAD DEVELOPED. UPON THE FIRST ANGIO RUN IT WAS CLEAR THAT THE ICA WAS OCCLUDED STARTING AT THE ICA/ECA JUNCTION. AT THIS TIME A SOPHIA ASPIRATION CATHETER WAS INTRODUCED, AND A SUCCESSFUL ASPIRATION PASS WAS CONDUCTED. A SECOND PASS WAS CONDUCTED REMOVING SMALL REMANENT OF RESIDUAL THROMBUS. THE PATIENT WAS ADMINISTERED AN ADDITIONAL REGIMENT OF ANTI-THROMBOGENIC MEDICATION. WHEN SHE AWOKE THE SECOND TIME, ALL STROKE SYMPTOMS HAD SUBSIDED. THE PATIENT'S CONDITION ONE DAY POST-IMPLANT, WAS REPORTED TO BE FINE AND INTACT. ADDITIONAL INFORMATION RECEIVED INDICATED, DURING THE CASE WE EXPERIENCED AN ACUTE THROMBOSIS OF NEWLY IMPLANTED FRED X DEVICE. BY THE FACT THAT THE PATIENT WAS STILL IN THE ANGIO SUITE, A THROMBECTOMY PROCEDURE WAS INITIATED WITH SUCCESS. OVER THE WEEKEND THE PATIENT PRESENTED WITH ISCHEMIC STROKE SYMPTOMS AGAIN. UPON CT OBSERVATION IT WAS

  Patient problems: Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22208668 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THE AE WAS ADJUDICATED BY THE CEC AS ¿CAUSAL¿ TO DEVICE DUE TO 90% FREDX-IN-STENT STENOSIS. TO DATE, NO OTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Aneurysm expansion; Reduced Blood Flow

  MAUDE report 22120093 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY FRED X PAS: EVENT INFORMATION: EVENT TERM: SMALL ACUTE STROKES: EVENT #: 1 EVENT START DATE: 22-AUG-2024 POST OPERATIVE DAYS: 1 EVENT DESCRIPTION : PATIENT C/O SEVERE DIZZINESS. MRI OF BRAIN WAS PERFORMED THAT SHOWED SMALL ACUTE STROKES IN LEFT BASAL GANGLIA AND PERIVENTRICULAR WHITE MATTER ADJACENT TO THE LEFT VENTRICULAR TRIGONE. RELATIONSHIP TO STUDY DEVICE : POSSIBLE RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE RELATIONSHIP TO USE OF ANCILLARY DEVICE : NOT RELATED RELATIONSHIP TO STUDY DISEASE : NOT RELATED RELATIONSHIP TO CONCOMITANT DISEASE : NOT RELATED AE OUTCOME : RECOVERED/ RESOLVED ON 23-AUG-2024 TREATMENT/ ACTION TAKEN: ANTIPLATELET THERAPY WAS CHANGED FROM PLAVIX TO BRILINTA.

  Patient problems: Dizziness; Ischemia Stroke

  MAUDE report 20225242 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  AS REPORTED BY THE FRED X PAS CLINICAL STUDY: SUBJECT HAD ASYMPTOMATIC THROMBOSIS OF THEIR FRED-X CONSTRUCT AND COMPLETELY OCCLUDED THE ARTERY. THE COLLATERAL FLOW IS INTACT; SO THE SUBJECT DID NOT HAVE ANY NEURO EVENTS. IT WAS REPORTED BY THE CLINICAL STAFF THAT THERE IS A "CAUSAL" RELATIONSHIP OF THE STUDY DEVICE TO THE REPORTED ADVERSE EVENT. THE ADVERSE EVENT IS NOT RELATED TO THE INDEX ENDOVASCULAR PROCEDURE. PATIENT WAS ON DAPT AT THE 6 MONTH FOLLOW UP VISIT. ADDITIONAL INFORMATION RECEIVED: AT THE 6 MONTHS ANGIO, COMPLETE OCCLUSION OF RIGHT ICA JUST DISTAL TO THE CAROTID BIFURCATION WAS DEMONSTRATED. PATIENT WAS ASYMPTOMATIC. NEURO STATUS UNCHANGED. MEDS UNCHANGED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 19231557 ↗
• DeathMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS COMMUNICATED THROUGH THE FREDX PAS CLINICAL STUDY TECHNICAL EVENT REPORT, THE PATIENT SUFFERED AN IN-STENT OCCLUSION (AE1) ON POD 5 AND WAS GIVEN TNK BUT THEN HAD A CONTRALATERAL HEMORRHAGE (AE2). SHE WAS BROUGHT TO ANGIO TO TRY TO OPEN THE STENT WHICH WAS UNSUCCESSFUL, AND THE CONTRALATERAL HEMORRHAGE SIGNIFICANTLY INCREASED SO THE FAMILY ELECTED NOT TO PURSUE FURTHER INTERVENTION. THE PATIENT DETAILS, PROCEDURE DETAILS AND AE DETAILS ARE PENDING SITE ENTRY ON THE ELECTRONIC DATA CAPTURE SYSTEM. THE CONTRALATERAL HEMORRHAGE (AE2) WAS INDICATED AS NOT RELATED TO THE STUDY DEVICE, BUT PROBABLY RELATED TO THE INDEX PROCEDURE. ADDITIONAL INFORMATION INDICATED, EVENT: STENT OCCLUSION/STROKE. ¿PATIENT PRESENTED TO THE ED AS A TRANSFER FROM OUTSIDE HOSPITAL WITH ACUTE ONSET RIGHT-SIDED WEAKNESS, FACIAL DROOP, AND APHASIA. PATIENT GIVEN TNK AT OUTSIDE HOSPITAL AND TRANSFERRED. REVASCULARIZATION WAS ATTEMPTED BUT UNSUCCESSFUL. PRU 185 ON BRILLINTA.¿ PATIENT OUTCOME, FATAL. DATE OF DEATH: (B)(6) 2024. THE EVENT IS INDICATED AS PROBABLE RELATION TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY DISEASE. ADDITIONAL INFORMATION RECEIVED ON 28FEB2024: MEDICATION TYPE, TENECTEPLASE. INITI

  Patient problems: Hemorrhagic Stroke; Paralysis

  MAUDE report 18899889 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PLACEMENT OF A STENT IN THE CLINOID SEGMENT, THE PATIENT DEVELOPED A RIGHT ICA STROKE. THE PROXIMAL END OF THE STENT WAS POST PROCESSED WITH 14WIRE AND MICROCATHETER. THE DEVICE APPEARED OPEN AND OPPOSED TO THE VESSEL WALL. THE PATIENT WOKE UP AND THEN PROGRESSIVELY DEVELOPED RIGHT ICA STROKE SYNDROME. CTA/P WAS NEGATIVE, MRI WAS NEGATIVE, AND ANGIO WAS NEGATIVE. EVENTUALLY THE PATIENT CAME BACK TO BASELINE.

  Patient problems: Stroke/CVA

  MAUDE report 14493365 ↗