Stent FREDX4018-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842429114353), received between Jul 26, 2023 and Mar 23, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FRED X POST-APPROVAL STUDY (PAS) THAT DURING A SIX-MONTH DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) EVALUATION, THE PATIENTS RIGHT OPHTHALMIC ARTERY WAS OBSERVED TO BE COMPLETELY OCCLUDED. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED NO ASSOCIATED SYMPTOMS. THE ADVERSE EVENT WAS REPORTED TO BE ONGOING AT THE TIME OF DOCUMENTATION, WITH NO RESOLUTION DATE PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24671666 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IMAGING ON (B)(6) 2024 (5 MONTHS POST PROCEDURE) SHOWED OPHTHALMIC ARTERY OCCLUSION, WHICH WAS NOTED AFTER THE EVENT WHEN THE IMAGING WAS DONE. DEVICE RELATIONSHIP TO THE EVENT INDICATED BY SITE AS ¿PROBABLE.¿ INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2024 WHEN THE PATIENT WAS TREATED FOR A LEFT SUPERIOR HYPOPHYSEAL ANEURYSM EMBOLIZATION. NO ADDITIONAL ACTION WAS TAKEN AS THE PATIENT IS ASYMPTOMATIC.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23698230 ↗
• MalfunctionJul 29, 2025Migration; Migration

  AS REPORTED THROUGH FRED X PAS STUDY / TECHNICAL EVENT: TYPE OF DEVICE MALFUNCTION / DEFICIENCY: OTHER. SPECIFY OTHER: FRED-X MIGRATION AT 6 MO IMAGING. DESCRIPTION - TECHNICAL EVENT: CORE LAB FOUND EVIDENCE OF <5MM MIGRATION WITH COMMENT "UNSUBTRACTED IMAGING NOT SUBMITTED. PROXIMAL MIGRATION IS DIFFICULT TO MEASURE, BUT APPEARS TO BE APPROACHING 5MM. PROXIMAL DEVICE JUST COVERS THE PROXIMAL NECK". IMAGING HAS NOT RESULTED IN RETREATMENT TO DATE. THE CORELAB REPORTED FREDX PROXIMAL MIGRATION <5MM AT THE 6M FU IMAGING PERFORMED ON (B)(6) 2024. THE PI RE-REVIEWED THE IMAGES AND ¿PI AGREES THAT THERE HAS BEEN MIGRATION¿ AND COMPLETED A CORRESPONDING TE CRF. NO AE WAS REPORTED AS A RESULT OF THIS TE. THE PT MRS INCREASED FROM 0 TO 1 DUE TO AE #4: HEADACHE ¿INTERMITTENT ACHE NEAR LEFT PARIETAL REGION THAT LASTS ONLY A FEW SECONDS¿. THIS AE WAS REPORTED AND ADJUDICATED AS NOT RELATED TO FREDX DEVICE. PATIENT MEDICAL HISTORY: CONGENITAL HEART DEFECTS, CORONARY ARTERY DISEASE, HYPERTENSION, CHRONIC OR PAROXYSMAL ATRIAL FIBRILLATION, HYPERLIPIDEMIA, PROSTATE PROBLEMS (URINARY RETENTION), PAST TIA X2 IN 2019, CKD STAGE 3A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649115 ↗
• MalfunctionJul 28, 2025Migration; Migration

  AS REPORTED THROUGH FRED X PAS STUDY / TECHNICAL EVENT: TYPE OF DEVICE MALFUNCTION / DEFICIENCY: OTHER. SPECIFY OTHER: FRED-X MIGRATION AT 6 MO IMAGING. DESCRIPTION - TECHNICAL EVENT : CORE LAB FOUND EVIDENCE OF <5MM MIGRATION WITH COMMENT "UNSUBTRACTED IMAGING NOT SUBMITTED. PROXIMAL MIGRATION IS DIFFICULT TO MEASURE, BUT APPEARS TO BE APPROACHING 5MM. PROXIMAL DEVICE JUST COVERS THE PROXIMAL NECK". IMAGING HAS NOT RESULTED IN RETREATMENT TO DATE. THE CORELAB REPORTED FREDX PROXIMAL MIGRATION <5MM AT THE 6M FU IMAGING PERFORMED ON (B)(6) 2024. THE PI RE-REVIEWED THE IMAGES AND ¿PI AGREES THAT THERE HAS BEEN MIGRATION¿ AND COMPLETED A CORRESPONDING TE CRF. NO AE WAS REPORTED AS A RESULT OF THIS TE. THE PT MRS INCREASED FROM 0 TO 1 DUE TO AE #4: HEADACHE ¿INTERMITTENT ACHE NEAR LEFT PARIETAL REGION THAT LASTS ONLY A FEW SECONDS¿. THIS AE WAS REPORTED AND ADJUDICATED AS NOT RELATED TO FREDX DEVICE. PATIENT MEDICAL HISTORY: CONGENITAL HEART DEFECTS, CORONARY ARTERY DISEASE, HYPERTENSION, CHRONIC OR PAROXYSMAL ATRIAL FIBRILLATION, HYPERLIPIDEMIA, PROSTATE PROBLEMS (URINARY RETENTION), PAST TIA X2 IN 2019, CKD STAGE 3A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628462 ↗
• MalfunctionApr 18, 2024Positioning Problem; Unintended Movement; Positioning Problem; Unintended Movement

  IT WAS REPORTED THAT THE FLOW DIVERTER STENT WAS USED TO TREAT A RIGHT INTERNAL CAROTID ARTERY (ICA) SIDEWALL ANEURYSM NEAR THE ORIGIN OF THE POSTERIOR COMMUNICATING ARTERY (PCOM). PATIENT PRESENTED WITH AN ACUTE ANGLE FROM RIGHT SUBCLAVIAN TO RIGHT COMMON CAROTID ARTERY (CCA) ORIGIN. ACCESS WAS FROM THE RIGHT SUBCLAVIAN AND THE STENT WAS TAKEN TO RIGHT ICA TERMINUS. REPORTEDLY, DEPLOYMENT OF THE STENT HAD BEGUN AND TENSION ON THE DEVICES DRAGGED THE DEVICE BACK PASSED THE ANEURYSM NECK. THE PHYSICIAN THEN TRIED RE-SHEATHING THE DEVICE AND WAS NOT ABLE TO. WHILE TRYING TO RE-SHEATH, BOTH THE STENT AND MICROCATHETER ADVANCED FORWARD SLIGHTLY PASSED THE ANEURYSM. THE FINISHED ENDS OF THE STENT SNAGGED ONTO A COIL THAT WAS PLACED INTO THE ANEURYSM; HOWEVER, THE COIL REMAINED IN THE ANEURYSM. WITH THE INABILITY TO RE-SHEATH, THE PHYSICIAN THEN DECIDED TO DEPLOY THE STENT, WHICH OPENED WITHOUT ANY ISSUES IN THE CORRECT LOCATION WITH MINIMAL 1MM COVERAGE ON DISTAL END. PATIENT WAS STABLE AND IS BEING MONITORED. ACCESS FROM RT SUBCLAVIAN TO RT (CCA) BELIEVED TO HAVE PLAYED A PART IN THE DIFFICULT DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131172 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE HAS CONFIRMED THE MECHANICAL THROMBECTOMY WAS SUCCESSFUL WITH EXCELLENT REVASCULARIZATION. THE PATIENT WAS CLINICALLY COMPLEX DUE TO CONCOMITANT METASTATIC CANCER BUT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024.

  Patient problems: Stroke/CVA

  MAUDE report 19122450 ↗
• InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H10.

  Patient problems: Ischemia Stroke; Paralysis; Thrombosis/Thrombus

  MAUDE report 18965881 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 17406704 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF EYE FLOATERS HAD AN ANEURYSM THAT WAS TREATED WITH A FRED X FLOW DIVERTER. A NEW FLOATER OCCURRED POST-PROCEDURE WHICH WAS POSSIBLY RELATED TO THE DEVICE AND STENOSIS OF THE OPHTHALMIC ARTERY.

  Patient problems: Stenosis; Vitreous Floaters

  MAUDE report 17394801 ↗