Stent FREDX5026-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429114469), received between May 19, 2022 and Aug 27, 2025 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED THROUGH FREDX PAS CLINICAL STUDY: PER CORELAB IMAGE READ OF THE 6-MONTH FU IMAGING PERFORMED ON (B)(6) 2024, "PROXIMAL FORESHORTENING" OF THE FREDX STENT WAS REPORTED. NO REPORT OF INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909153 ↗
• InjuryNov 16, 2022Stretched; Activation Problem; Stretched; Activation Problem

  IT WAS REPORTED THAT THE FRED STENT WAS USED TO TREAT A 4.3MM DISTAL X 5.0MM PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE STENT WAS IMPLANTED WITH PROXIMAL END TWISTED. THE PHYSICIAN IMPLANTED A NON-MICROVENTION STENT IN THE CLOSED SEGMENT FOLLOWED BY BALLOON ANGIOPLASTY TO ENSURE OPEN INNER LUMEN. PATIENT WAS STABLE DURING ENTIRE PROCEDURE AND WAS DOING WELL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810726 ↗
• DeathSep 23, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING AN ICA ANEURYSM TREATMENT, THE FREDX DISTAL PORTION WAS PLACED AT ICA TERMINUS AND WAS OPENED AT THE OPPOSED VESSEL WALL, BUT THE PROXIMAL PORTION DID NOT OPEN FULLY PAST A CURVE IN THE PATIENT'S NEUROVASCULAR ANATOMY. THE PHYSICIAN RE-SHEATHED AND RE-DEPLOYED THE FREDX MULTIPLE TIMES TO TRY TO OPEN THE PROXIMAL END FULLY. AFTER COMPLETE DEPLOYMENT, THE PHYSICIAN MADE SEVERAL ATTEMPTS TO OPEN THE PROXIMAL END BY USING A MICROCATHETER AND GUIDEWIRE, BUT HE WAS UNABLE TO GAIN ACCESS TO THE FREDX. THE PHYSICIAN THEN CHOSE TO ENTER THE CONTRALATERAL VASCULATURE THROUGH THE ACOM TO ACCESS THE FREDX WITH A SL-10 MICROCATHETER, AND HE WAS ABLE TO OPEN THE PROXIMAL PORTION OF THE FREDX WITH AMPLE WALL APPOSITION. THE PHYSICIAN DID A FINAL RUN OF THE PROCEDURE AND DID NOT NOTICE ANYTHING. AT SOME POINT, THE PATIENT WAS BROUGHT BACK TO THE ANGIOSUITE AND THE PHYSICIAN NOTICED A VESSEL BLEED ON THE CONTRALATERAL VASCULATURE THAT WAS NOT NOTICED DURING THE FINAL RUN OF THE PROCEDURE. THE PATIENT PASSED AWAY DUE TO BLEEDING ON THE CONTRALATERAL SIDE IN THE ACOM/A1 REGION. IT WAS REPORTED THAT THE VESSEL BLEED WAS DUE TO THE PHYSICIAN'S MANEUVER ACCESSING THE DISTAL P

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15471992 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST PLACEMENT OF A FRED X STENT, THE PATIENT WAS RE-ADMITTED WITH A LEFT HEMISPHERIC STROKE. THERE WERE NO COMPLICATIONS DURING THE PLACEMENT OF THE FRED X STENT IN THE LEFT ICA. THE VESSEL'S PROXIMAL SIZE WAS APPROXIMATELY 4.5 MM. THE VESSEL'S DISTAL SIZE WAS APPROXIMATELY 3.83 MM. ONE DAY POST PROCEDURE, HOWEVER, THE PATIENT HAD A LARGE OPHTHALMIC SEGMENT ANEURYSM AND WAS RE-ADMITTED WITH A LEFT HEMISPHERIC STROKE. A CLOT WAS NOTICED ON THE DISTAL PORTION OF THE FRED X DEVICE. IT WAS REPORTED THAT THE PATIENT WAS NON-COMPLIANT WITH POST-PROCEDURE TREATMENT PROTOCOL.

  Patient problems: Stroke/CVA

  MAUDE report 14436984 ↗