Stent FREDX3522-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429114315), received between Aug 2, 2022 and Jun 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Unintended Movement; Unintended Movement

  AS REPORTED THROUGH THE CLINICAL STUDY FRED X PAS: THE DATE OF ORIGINAL FRED X PROCEDURE / DATE OF IMPLANTATION WAS (B)(6) 2023. DURING THE 6-MONTH FOLLOW-UP IMAGING ON (B)(6) 2025, PERSISTENT RESIDUAL FILLING OF THE RIGHT POSTERIOR COMMUNICATING ARTERY ORIGIN ANEURYSM AND FORESHORTENING OF THE STENT WAS DISCOVERED. THE PATIENT'S CURRENT CONDITION ON (B)(6) 2025 IS NOTED AS "MRS & NIHSS IS 0". PATIENT WAS RETREATED WITH OVERLAPPING FLOW DIVERTER. INFORMATION RECEIVED INDICATED: DID SUBJECT REQUIRE OTHER TREATMENT/INTERVENTION AS A RESULT OF THE MALFUNCTION/DEFICIENCY THAT IS NOT ASSOCIATED WITH ANY ADVERSE EVENT? YES COULD THIS TECHNICAL EVENT HAVE LED TO A SERIOUS ADVERSE DEVICE EFFECT (SADE): 1. IF EITHER SUITABLE ACTION HAD NOT BEEN TAKEN, 2. IF INTERVENTION HAD NOT BEEN MADE, OR 3. IF CIRCUMSTANCES HAD BEEN LESS FORTUNATE: NO EVENT TERM: RESIDUAL NECK OF TARGET ANEURYSM EVENT DESCRIPTION: PERSISTENT RESIDUAL FILLING OF THE RIGHT POSTERIOR COMMUNICATING ARTERY ORIGIN ANEURYSM DUE TO FREDX FORESHORTENING. SEVERITY: MODERATE WAS THIS A SERIOUS AE?: YES DATE AE WAS DETERMINED TO BE AN SAE: (B)(6) 2025. INTERVENTION: X, MRS: X, NIHSS: X, WAS THE AE CAUSED BY OR ASSOCIATED WITH A TEC

  Patient problems: Aneurysm expansion

  MAUDE report 22365676 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED DEVICE WAS USED FOR TREATING A PATIENT FOR LEFT PCOMM AND ANTERIOR CHOROIDAL ANEURYSMS. THE PCOMM MEASURED 1.6X2.7X2.6 (NECK 2.5) AND THE ANTERIOR CHOROIDAL MEASURED 2.5X2X2 (NECK 1.5). ON THE DAY OF PROCEDURE THE ICA VESSEL MEASURED PROXIMAL 3.03 AND DISTAL 3.2. DID NOT RE-SHEATH DURING DEPLOYMENT. WHEN PATIENT WOKE UP WITH TRANSIENT RIGHT SIDED WEAKNESS, THE DAPT CHANGED TO BRILENTA. PATIENT EXPERIENCED TRANSIENT ISCHEMIC ATTACK (TIA) SYMPTOMS A COUPLE HOURS AFTER PROCEDURE (PROBLEM FORMED SOME CLOT IN STENT THEN) AND WAS CONVERTED TO TICAGRELOR (BRILENTA) WHERE SYMPTOMS SUBSIDED. THE PATIENT WAS DISCHARGED THE NEXT DAY AFTER PROCEDURE AND REPORTEDLY CAME BACK THAT EVENING WITH A PERFORATOR STROKE WITH DECREASED PERFUSION BY MRI. TEN DAYS LATER, THE PATIENT RETURNED WITH FLOW LIMITING CLOT IN STENT (STROKE) AND THE PHYSICIAN UTILIZED A STENT RETRIEVER AND ASPIRATION TO REMOVE THE FIBROUS CLOT. THE NEXT DAY ICA VESSEL RE-MEASUREMENT WAS PERFORMED AS PROXIMAL LAT 2.9/3.2 AND PROXIMAL AP 3.4 AND DISTAL 3.1. THE PATIENT IS STILL IN HOSPITAL WITH RIGHT SIDED ARM AND LEG DEFICITS. REHAB RECOMMENDED.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA; Transient Ischemic Attack

  MAUDE report 15153882 ↗