Stent FREDX5015-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842429114445), received between Feb 28, 2023 and Apr 13, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (3 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 16, 2026.

Recalls naming this device

1. Sep 5, 2025Open, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Activation Problem

  NO NEW INFORMATION PROVIDED. SEE SECTION B3 FOR DATE OF EVENT CORRECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865615 ↗
• InjuryDec 26, 2025Migration; Migration

  IT WAS REPORTED THAT THE FLOW DIVERTER STENT WAS USED TO TREAT A PREVIOUSLY TREATED RUPTURED POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. THERE WAS A REMNANT FROM THE USE OF AN INTRALUMINAL FLOW DISRUPTION WEB DEVICE IN THIS RUPTURED PCOM. THE ANEURYSM LOCATION WAS AT DISTAL ICA. DISTAL MEASUREMENT OF THE ICA WAS 4.4MM AND PROXIMAL LANDING ZONE TO THE ANEURYSM MEASURED 3.8MM. THE SIZE OF STENT CHOSEN WAS A 5X15/9. PROPER PREP OF THE STENT WAS COMPLETED BEFORE ADVANCING INTO THE MICROCATHETER. THE DEVICE OPENED AND DEPLOYED NICELY WITH GOOD APPOSITION TO THE VESSEL WALL. REPORTEDLY, ABOUT 3 HOURS LATER, THE PHYSICIAN REPORTED THAT THE PATIENT HAD EXPERIENCED STROKE SYMPTOMS AND COULD NOT MOVE HALF OF THEIR BODY. THE PATIENT WAS TAKEN BACK TO THE ANGIO SUITE FOR IMAGING WHERE IT WAS DISCOVERED THAT THE STENT HAD MIGRATED INTO THE M1 SEGMENT AND HAD CLOT FORMATION INSIDE. THE PATIENT WAS GIVEN INTEGRALIN AND HAS IMPROVED. REPORTEDLY, THERE WAS SPASM EARLIER IN THE PROCEDURE. VERAPAMIL WAS GIVEN ABOUT 30-45 MINUTES BEFORE STENT WAS DEPLOYED. CURRENTLY THE PATIENT IS DOING A LITTLE BIT BETTER, BUT STILL HAD A STROKE AND IS WEAK ON THE LEFT SIDE. THE STENT WAS OVERSIZED AND WAS OPPOSE

  Patient problems: Cramp(s) /Muscle Spasm(s); Ischemia Stroke; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 23898338 ↗
• InjuryFeb 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: CASE WAS FLOW DIVERSION OF THE ICA. WE SELECTED THE FREDX SIZE FOR THE VESSEL AND PREPPED PER IFU. UPON ATTEMPT AT DEPLOYMENT STENT BEGAN TO OPEN DISTALLY & THEN STOPPED OPENING. WE RECAPTURED AND REMOVED DEVICE CHECKED AGAIN IN BOWL LOOKED LIKE IT WAS OPEN OK SO WE ATTEMPTED A SECOND ATTEMPT. UPON SECOND ATTEMPT TO DEPLOY DEVICE IT AGAIN OPENED DISTALLY BUT WOULD NOT OPEN IN THE MIDDLE. WE REMOVED DEVICE, SELECTED A DIFFERENT SIZE AND LENGTH OF DEVICE AND PREPPED AN INTRODUCED NEW FRED X. THE NEW DEVICE OPENED AND DEPLOYED JUST AS PLANNED. PATIENT WOKE UP POST PROCEDURE AND APPEARED TO HAVE MOBILITY OF ALL EXTREMATIES. POSSIBLE EFFASIA BUT WAS NOT COMPLETELY AWAKE AND FULLY ASSESSED AT THAT TIME. DESCRIPTION OF INTERVENTION: AFTER DEVICE DEPLOYMENT UPON DOING COMPLETION RUNS WE NOTICED CLOT IN THE M1/M2 SEGMENT. WE CROSSED BACK THROUGH THE FLOW DIVERTER WITH A HEADWAY 21 AND A SOFIA 5F 125 AND WENT AFTER THE CLOT 1ST PASS WITH TREVO STENT TREAVER OPEN UP M1/M2 BUT CLOT MOVED DISTAL WE MADE SECOND PASS WITH TREVO AND WERE ABLE TO RETRIEVE CLOT. PATIENT CURRENT CONDITION/OUTCOME: PATIENT WAS IMPROVING IMMEDIATE POSTOPERATIVE UNTIL ICU TRANSFER. WAS DOING WELL BUT FOLLOW

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21340668 ↗
• InjuryJan 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY: INCOMPLETE OPEN OF THE FRED X DEVICE DISTAL TO THE ANEURYSM. THIS TECHNICAL EVENT COULD NOT HAVE LED TO A SERIOUS ADVERSE DEVICE EFFECT (SADE). INCOMPLETE STENT EXPANSION OCCURRED AFTER DEVICE WAS DETACHED AND A BALLOON ANGIOPLASTY WAS PERFORMED. DEVICE WAS IMPLANTED WITH NO VISIBLE ENDOLEAK POST BALLOON ANGIOPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098534 ↗
• MalfunctionMay 14, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE FLOW DIVERTER STENT WAS USED IN THE TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. REPORTEDLY, ON 6-MONTH FOLLOW-UP VISIT, IT WAS NOTED THAT THE STENT WAS POTENTIALLY NOT WELL OPPOSED TO THE VESSEL WALL AT THE PROXIMAL PORTION OF THE STENT. THE PATIENT IS ASYMPTOMATIC AND THE PHYSICIAN IS NOT DOING ANYTHING FURTHER AND IS WATCHING THE PATIENT AT THIS TIME. DATE OF INDEX PROCEDURE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316264 ↗
• MalfunctionDec 22, 2023Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  AS REPORTED THROUGH A FRED X CLINICAL STUDY, THE FRED X DEPLOYED AS INTENDED AT THE DISTAL LANDING ZONE, OPENED ACROSS THE NECK, BUT FAILED TO OPEN ALONG THE PROXIMAL CURVATURE. THE FRED X COULD NOT BE CAPTURED, RETRACTED WITHIN THE MICROCATHETER. THE DEVICE WAS SUCCESSFULLY RECAPTURED THROUGH THE ADVANCEMENT OF THE INTERMEDIATE CATHETER. A PIPELINE STENT WAS PLACED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387539 ↗
• InjuryOct 24, 2023Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  ADDITIONAL INFORMATION PROVIDED INDICATED A PIPELINE STENT WAS PLACED DISTAL TO THE PREVIOUSLY IMPLANTED FRED X ON (B)(6) 2023. THE PATIENT WAS DISCHARGED WITHOUT FURTHER SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000299 ↗
• InjuryFeb 28, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT A FLOW DIVERTER WAS IMPLANTED IN THE PATIENT PARTIALLY OPENED. AN ATTEMPT WAS MADE TO OPEN THE STENT FULLY BY USING A BALLOON, BUT IT FAILED. THE PHYSICIAN DECIDED TO LEAVE THE DEVICE IMPLANTED IN ITS CURRENT POSITION, AND THE PROCEDURE WAS COMPLETED. INTEGRILIN WAS ADMINISTERED. THE PATIENT WAS DISCHARGED AND WENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456146 ↗