Stent FREDX5021-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429114452), received between Jun 22, 2022 and Feb 4, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A FRED X PAS CLINICAL STUDY, AT A 30 DAY FOLLOW UP VISIT, THE PATIENT REPORTED NUMBNESS IN LEFT HAND POST DISCHARGE. THE RELATIONSHIP TO STUDY DEVICE IS POSSIBLE, RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE IS POSSIBLE, RELATIONSHIP TO USE OF ANCILLARY DEVICE IS POSSIBLE, RELATIONSHIP TO STUDY DISEASE IS POSSIBLE AND RELATIONSHIP TO CONCOMITANT DISEASE IS POSSIBLE. THE SEVERITY IS MILD. THE AE OUTCOME IS ONGOING. ADDITIONAL INFORMATION OF THE EVENT WAS REQUESTED FROM THE REPORTER INCLUDING FURTHER TREATMENT PLANNED. NO INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Numbness

  MAUDE report 21307543 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY: STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY. PATIENT REPORTED TO AN OSH FOR VISION CHANGES, LIGHT FLASHES IN THE RIGHT EYE, AND DIZZINESS THAT WAS ONGOING FOR A WEEK PRIOR TO SEEKING MEDICAL ATTENTION. CTA HEAD/NECK SHOWED SEVERE NARROWING THROUGHOUT THE RIGHT INTERNAL CAROTID ARTERY. PATIENT TRANSFERRED TO STUDY SITE THE NEXT DAY WHERE PATIENT REPORTS SIMILAR SYMPTOMS AS BEFORE ALONG WITH A RIGHT- SIDED HEADACHE IN CONJUNCTION WITH THE VISION CHANGES; AND EPISODES OF EXPRESSIVE APHASIA VS GARBLED SPEECH. DSA DONE THE DAY AFTER PATIENT WAS TRANSFERRED SHOWS SEVERE FREDX IN STENT STENOSIS. THE EVENT HAS A PROBABLE RELATION TO THE STUDY DEVICE.

  Patient problems: Dizziness; Flashers; Headache; Stenosis

  MAUDE report 20802554 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A CLINICAL STUDY, THE PATIENT HAD A SEIZURE POST IMPLANTATION OF A FLOW DIVERTER. THE RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE CANNOT BE RULED OUT. THE PATIENT PRESENTED TO THE HOSPITAL WITH GENERALIZED WEAKNESS AND MUSCLE ACHING AND SHORTNESS OF BREATH. PATIENT WAS RELEASED HOME AND WOKE UP WITH HAVING A GENERALIZED CONVULSION. PATIENT TURNED BLUE AND NO FEEL OF THE PATIENT'S PULSE AFTERWARDS. UPON AWAKENING THE PATIENT WAS MILDLY CONFUSED WITHOUT UNILATERAL WEAKNESS BUT THE PATIENT DID ENDORSE GENERALIZED WEAKNESS AND A SENSE OF PARALYSIS. PATIENT DENIES ANY RECENT WARNING SIGNS. THE PATIENT HAS HAD A LONGSTANDING ODD SENSATION OF FACIAL BURNING AND FLUSHING FOR ABOUT A YEAR THAT ULTIMATELY LED TO THE DISCOVERY OF AN ANEURYSM. NO RECURRENT SEIZURES SINCE COMING TO THE EMERGENCY DEPARTMENT. NO PRIOR PERSONAL OR FAMILY HISTORY OF SEIZURES. A CEREBRAL ANGIOGRAM WAS PERFORMED AND NO STENOSIS WAS FOUND. MEDICATIONS WERE CHANGED. PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Convulsion/Seizure

  MAUDE report 17330243 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SAME DAY, AFTER PLACEMENT OF A FLOW DIVERTER, THE PATIENT EXPERIENCED NEUROLOGICAL CHANGES; THEREFORE, A BOLUS OF MEDICATION WAS PROVIDED AND THE SYMPTOMS RESOLVED WITH NO FURTHER TREATMENT. TREATMENT SITE WAS RIGHT PCOM. DURING PLACEMENT OF THE FLOW DIVERTER, IT WAS NOTED THAT IT WAS DIFFICULT TO OPEN THE DEVICE AROUND CURVES AND THAT THE DEVICE WAS FALLING BACK OR MIGRATING PROXIMALLY. THE DISTAL LANDING ZONE WAS CHANGED TO PROXIMAL M1. THE FLOW DIVERTER WAS IMPLANTED. CT EXAM WAS PERFORMED AFTER SYMPTOMS APPEARED AND AN INITIAL DIAGNOSIS OF "PARTIAL THROMBOSIS OF THE DISTAL STENT" WAS MADE. UPON THE PATIENT'S RETURN TO THE ANGIOSUITE, THROMBOSIS WAS NOT OBSERVED AND NO FURTHER TREATMENT WAS REQUIRED. CYNA CT WAS PERFORMED EIGHT DAYS POST-TREATMENT AND BEFORE DISCHARGE, WHICH SHOWED NO ISSUES. THE PATIENT IS REPORTED AS GOOD.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 14781204 ↗