Stent FREDX4525-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429114414), received between Jun 2, 2022 and Sep 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Activation Problem” (2 reports).

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 18, 2026.

Recalls naming this device

1. Sep 5, 2025Class IIOpen, 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.

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

  IT WAS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY THAT THE FOLLOWING EVENT WAS POSSIBLY DEVICE RELATED: EVENT # : 3 EVENT TERM: LEFT SIDED SCOTOMAS IMPLANT DATE: (B)(6) 2025, EVENT START DATE: (B)(6) 2025, DATE SITE WAS MADE AWARE OF THE EVENT: 20-AUG-2025. EVENT DESCRIPTION: PT HAD A BRIEF LEFT SIDED SCOTOMAS, SEVERITY: MILD WAS THIS A SERIOUS AE? : NO RELATIONSHIP TO STUDY DEVICE: POSSIBLE, RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE : POSSIBLE, RELATIONSHIP TO USE OF ANCILLARY DEVICE : POSSIBLE, RELATIONSHIP TO STUDY DISEASE : NOT RELATED, RELATIONSHIP TO CONCOMITANT DISEASE : NOT RELATED, AE OUTCOME : RECOVERED/RESOLVED, DATE OF RESOLUTION - RECOVERED/RESOLVED : (B)(6) 2025. ADDITIONAL INFORMATION INDICATED: NO ACTION WAS NEEDED AS IT WAS A BRIEF EPISODE WHICH RESOLVED ON IT¿S OWN ON THE SAME DAY.

  Patient problems: Loss of Vision

  MAUDE report 22974311 ↗
• InjurySep 2, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THROUGH THE CLINICAL STUDY FREDX PAS A NONFLOW-LIMITING, NON-ATHEROSCLEROTIC, APPROXIMATELY 40% STENOSIS OF THE COMMUNICATING SEGMENT OF THE RIGHT ICA FROM INTIMAL HYPERPLASIA. ATORVASTATIN WAS INCREASED. TARGET IA: RIGHT OPHTHALMIC ANEURYSM. AN IMAGE READ OF THE 6-MONTH FU IMAGING PERFORMED ON 12 AUG 2024, "25-50% DISTAL FISH-MOUTHING" OF THE FREDX STENT WAS REPORTED. THE PATIENT IS ASYMPTOMATIC. 12-MONTH FOLLOW-UP MRS WAS 0 AND HAS REMAINED 0 SINCE BASELINE AND POST-PROCEDURE. ATORVASTATIN DOSE WAS INCREASED AND ASPIRIN WAS CONTINUED. NO FURTHER ACTION. THERE IS NO INTERVENTION/TREATMENT PLANNED TO ADDRESS THE FISHMOUTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947899 ↗
• InjuryNov 26, 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: EPISODE OF NUMBNESS AND TINGLING IN THE RIGHT EXTREMITY. PATIENT WENT TO ED AND REPORTED SOME NUMBNESS AND TINGLING IN THE RIGHT ARM. THE EVENT WAS NOT CLASSIFIED AS A SERIOUS ADVERSE EVENT. THE EVENT WAS NOT ASSOCIATED WITH A TECHNICAL EVENT. THE NUMBNESS AND TINGLING ARE POSSIBLY RELATED TO THE STUDY DEVICE, INDEX PROCEDURE AND STUDY DISEASE. THE EVENT WAS RECOVERED/RESOLVED ON THE SAME DAY. NO IMAGING WAS PERFORMED. NO INTERVENTION WAS PERFORMED IN REGARD TO THE NUMBNESS AND TINGLING. SUBJECT WAS ADVISED TO CONTINUE TAKING [ORAL ANTIPLATELET]. POST-OP 13 DAYS, MRS WAS 0. POST-OP 188 DAYS, IMAGING SHOWED THE ANEURYSM OCCLUSION WAS A RAYMOND SCALE 1 AND THE PARENT ARTERY WAS 100% PATENT, MRS AND NIHSS WAS 0.

  Patient problems: Numbness

  MAUDE report 20778543 ↗
• InjuryApr 22, 2024Activation Failure; Activation Problem; Activation Failure; Activation Problem

  IT WAS REPORTED THAT A STENT WAS IMPLANTED TO TREAT AN ANEURYSM OF THE LEFT PCOMM SEGMENT OF THE ICA. STASIS WAS VISUALIZED IN THE ANEURYSM HOWEVER LESS THAN ADEQUATE WALL APPOSITION WAS NOTED ON THE PROXIMAL SEGMENT OF THE STENT AFTER REMOVAL OF THE PUSHER WIRE. IT WAS ATTEMPTED TO OPEN THE STENT WITH A MICROCATHETER, WHICH DID NOT WORK, AND A BALLOON WHICH ALSO DID NOT WORK. SINCE FLOW WAS NOT LIMITED, THE STENT WAS LEFT AS IS. THE PATIENT WAS REPORTED TO BE DOING "WELL" THE DAYS AFTER THE OPERATION. THE PHYSICIANS EXPECT THE ANEURYSM TO BE GONE IN 6-12 MONTHS BUT THERE IS SEVERE STENT STENOSIS AND SHORT TERM FOLLOW UP (3 MONTHS) WAS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154330 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FIFTEEN MINUTES POST PLACEMENT OF A STENT, OCCLUSIVE FLOW AND A CLOT IN THE STENT WERE DISCOVERED. MEDICATION WAS ADMINISTERED RESULTING IN A FULLY OPENED STENT WITH FULL PATENCY OF THE VESSEL. THE TREATMENT WAS FOR AN ANEURYSM IN THE LEFT VERTEBRAL ARTERY. THE STENT WAS DEPLOYED WITHOUT ISSUE. POST DEPLOYMENT INJECTIONS SHOWED AN OPEN STENT AND FULL PATENCY OF THE VESSEL. THE ANATOMY WAS TORTUOUS. FIFTEEN MINUTES AFTER THE PROCEDURE, THE PATIENT SHOWED SYMPTOMS AND AN ANGIOGRAM WAS PERFORMED SHOWING OCCLUSIVE FLOW AND A CLOT IN THE STENT. THE PHYSICIAN WENT UP WITH A MICROCATHETER AND ADMINISTERED INTEGRILIN AT THE PROXIMAL END OF STENT. THE PHYSICIAN THEN PROCEEDED TO CROSS THE STENT WITH A J-SHAPED WIRE AND WAS ABLE TO FULLY CROSS WITH A COMPETITOR CATHETER. THE PHYSICIAN THEN PROCEEDED TO INJECT MORE INTEGRILIN AS THE PHYSICIAN PULLED BACK ON THE CATHETER. FINAL ANGIO WAS PERFORMED AND INDICATED A FULLY OPEN STENT WITH FULL PATENCY OF THE VESSEL. THE PATIENT WAS LEFT INTUBATED AFTER RESCUE PROCEDURE AND SENT TO ICU. IT WAS REPORTED THAT THE PATIENT WAS A LITTLE BETTER. THE PATIENT IS ALERT AND FOLLOWING SOME COMMANDS. THE PATIENT HAS LEFT SIDE NEGLECT AND W

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14577439 ↗