Stent FREDX4515-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429114391), received between Jul 12, 2022 and Apr 22, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Structural Problem; Material Twisted/Bent

  AS REPORTED THROUGH THE (B)(6) CLINICAL STUDY: THE LAB REPORTED DISTAL FISHMOUTHING 25-50%, EXACT PERCENTAGE IS NOT KNOWN. FISHMOUTHING WAS OBSERVED BY THE LAB ON THE 6 MONTH FOLLOW-UP IMAGING, POST DETACHMENT. THE LAB ALSO REPORTED (B)(6) BRAID BUMP DEFORMATION AT THE 6 MONTH FOLLOW-UP IMAGING. THE 6 MONTH FOLLOW-UP IMAGING WAS PERFORMED A YEAR PRIOR TO THE LAB REVIEWING THE IMAGING. FISH-MOUTHING WAS ALSO NOTED BY THE LAB ON THE 12 MONTH FOLLOW-UP IMAGING. THERE IS NO PLANNED INTERVENTION TO ADDRESS THE FISH-MOUTHING. THE TREATMENT SITE DURING THE INDEX PROCEDURE IS A LEFT SUPRACLINOID ANEURYSM. ANEURYSM IS FULLY OCCLUDED (RAYMOND-ROY 1). NO CORRESPONDING ADVERSE EVENT OR TREATMENT HAVE BEEN REPORTED FOR THIS SUBJECT. SUBJECT IS WAITING FOR 2 YEAR FOLLOW-UP VISIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958713 ↗
• MalfunctionApr 11, 2026Unintended Movement

  IT WAS REPORTED THAT AT THE SIX-MONTH FOLLOW-UP IMAGING PERFORMED ON (B)(6) 2025, A FIVE MILLIMETER OR GREATER FRED X DEVICE MIGRATION WAS OBSERVED, WITH THE COMMENT THAT BOTH PROXIMAL AND DISTAL MARKERS HAD MOVED DISTALLY. IT WAS FURTHER REPORTED THAT, IN ADDITION TO THE MIGRATION, DISTAL BRAID COLLAPSE AND A BRAID BUMP WERE ALSO IDENTIFIED ON THE SAME SIX-MONTH FOLLOW-UP IMAGING. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS "NO ADVERSE EVENTS WERE REPORTED". AND THE MODIFIED RANKIN SCALE SCORE REMAINED 0 AT BOTH THE SIX-MONTH AND TWELVE-MONTH FOLLOW-UP VISITS PERFORMED ON (B)(6) 2025 AND (B)(60 2026, RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850698 ↗
• InjuryFeb 13, 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: INTIMAL HYPERPLASIA-MODERATE. AT THE 6 MONTH ASSESSMENT, THE MID PORTION OF THE FLOW DIVERTER SHOWED MODERATE (60% STENOSIS) NON-FLOW LIMITING NEO-INTIMAL HYPERPLASIA. SEVERITY WAS CLASSIFIED AS MODERATE. TREATMENT WAS CONTINUATION OF DAPT WITH MEDICATION. PATIENT STATUS IS ONGOING. MRS IS 1 (SAME AS BASELINE). NIHSS IS 0. THE RELATIONSHIP BETWEEN THE EVENT AND STUDY DEVICE (FRED) WAS DETERMINED TO BE CAUSAL.

  Patient problems: Stenosis

  MAUDE report 21381618 ↗
• InjuryMay 18, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE FLOW DIVERTER DEVICE WAS DEPLOYED SUCCESSFULLY. AFTER THE POST-DEPLOYMENT ANGIO RUN, THE STENT MAY NOT HAVE BEEN FULLY OPEN WITH THE LIMITED FLOW IN THE LEFT ACA. IMMEDIATELY, THE ANEURYSM WAS ELIMINATED THRU LOW DIVERSION. THE STENT WAS CROSSED WITH A GUIDEWIRE AND A BALLOON WAS USED. AFTER A SERIES OF FAILED ATTEMPTS, THE STENT BUNCHED UP PREVENTING THE BALLOON TO MOVE. THE PATIENT WAS ADMINISTERED .25 KILOGRAMS OF KANGELOR AND CLOSED THE ACCESS WITH THE STENT REMAINING IMPLANTED. BEFORE THE PROCEDURE, ANTIPLATELET DRUGS P2Y12 WAS 20 AND WHEN THE STENT WAS DEPLOYED, IT WAS 51. IMMEDIATELY AFTER THE PATIENT WOKE UP, THERE WITH A MINIMAL DEFICIT, AND TWELVE HOURS LATER, THERE WERE NO SYMPTOMS. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16955967 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIRTEEN DAYS POST-IMPLANTATION OF A FLOW DIVERTER IN THE CAROTID OPHTHALMIC ARTERY, THE PATIENT RETURNED TO THE HOSPITAL EXHIBITING STROKE SYMPTOMS. IT WAS NOTED THAT THE FLOW DIVERTER WAS OCCLUDED WITH THROMBUS AND THE CLOT WAS RETRIEVED USING ASPIRATION. FLOW WAS RESTORED AND THE PATIENT IS NEUROLOGICALLY INTACT.

  Patient problems: Stroke/CVA

  MAUDE report 14989121 ↗