Stent FREDX3013-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842429114254), received between Oct 17, 2022 and Feb 24, 2026 — classified as 4 injuries, 2 malfunctions.

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

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Migration; Activation Problem

  IT WAS REPORTED THAT AN ANEURYSM WAS TREATED WITH A FRED WHERE STENOSIS IN THE MIDDLE OF THE STENT REQUIRED MULTIPLE TYPES OF INTERVENTION. THE PHYSICIAN PLACED A FRED 3 X 13MM STENT AND IMPLANTABLE COILS, WHICH IS AN OFF-LABEL USE OF THE STENT. WHEN STENOSIS OR INCOMPLETE OPENING WAS OBSERVED WITHIN THE MIDDLE SECTION OF THE STENT, THE PHYSICIAN ATTEMPTED TO OPEN THE STENT WITH A BALLOON CATHETER CAUSING THE ANEURYSM NECK TO BE INCOMPLETELY COVERED. THEN A SECOND FRED 3 X 13MM STENT WAS IMPLANTED SOMEWHAT OVERLAPPING AND TELESCOPING WITHIN THE FIRST FRED. AN ADDITIONAL LVIS EVO 3X18MM WAS THEN IMPLANTED SOMEWHAT OVERLAPPING AND TELESCOPING WITH THE OTHER STENT. A REPERFUSION CATHETER WAS PASSED THROUGH THE STENTS SMOOTHLY AND THERE WAS NO OBSERVED CLOT. THERE WERE ULTIMATELY 5-6 INTERVENTIONS WITH BALLOON CATHETERS AND STENTS TO ADDRESS THE STENOSIS. AFTERWARDS, THE STENTED SIDE REMAINED OPEN; HOWEVER, THE CONTRALATERAL VESSEL CLOSED DOWN. THE PATIENT ALSO HAD HYDROCEPHALUS AND A VENTRICULOSTOMY WAS NOTED PRIOR TO THE CASE. IT WAS ALSO REPORTED THAT COCAINE-INDUCED VASCULITIS AND VESSEL PATHOLOGY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT IS NOW IN A VEGETATIVE STATE.

  Patient problems: Coma; Stenosis

  MAUDE report 24431788 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN IMPLANTED STENT THAT THROMBOSED POST PROCEDURE. THERE ARE NO PLANS FOR THE PATIENT TO RECEIVE RETREATMENT. THE ANEURYSM IS OCCLUDED AS IS THE PARENT VESSEL (LEFT MCA). THE DOCTOR REFERRED THE PATIENT FOR BYPASS SURGERY TO AN OUTSIDE HOSPITAL. THE PATIENT HAD A STROKE AND CURRENTLY HAS STROKE SYMPTOMS.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 20625288 ↗
• MalfunctionNov 6, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED AFTER THE STENT WAS DEPLOYED AND COVERED THE ANEURYSM; THE PUSHER WIRE WAS ATTEMPTED TO BE REMOVED, BUT IT GOT STUCK IN THE FLARED ENDS. THE PUSHER LEAD WIRE WAS RELEASED FROM THE STENT¿S FLARED ENDS WITHOUT MIGRATING, AND THE ANEURYSM REMAINED COVERED BY THE STENT. THE ANEURYSM WAS TREATED WITH THIS STENT. NO PATIENT INJURY OR INTERVENTION WAS REPORTED. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076368 ↗
• MalfunctionNov 2, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE FRED X21 FLOW DIVERTER STENT WAS USED TO TREAT A PATIENT WITH ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THE STENT DEPLOYED AND COVERED THE ANEURYSM, BUT WHEN THE PHYSICIAN TRIED TO REMOVE THE PUSHER WIRE, IT WAS STUCK IN THE FLARED ENDS AND IT PULLED THE DEVICE BACK ABOUT 10MM AND THE ANEURYSM WAS COMPLETELY MISSED. REPORTEDLY, VESSEL ANATOMY WAS A FACTOR AS THERE WAS A 90 DEGREE TURN WHERE THE WIRE GOT CAUGHT. THE STENT WAS OPEN BUT THE PHYSICIAN WAS NOT ABLE TO CROSS THROUGH THE FREDX TO PLACE ANOTHER STENT AND THE ANEURYSM WAS NOT TREATED. THE PHYSICIAN IS WAITING FOR ENDOTHELIZATION BEFORE CONSIDERING ADDITIONAL TREATMENT. NO DAMAGE WAS CASED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058422 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RETURNED 10 DAYS POST IMPLANTATION OF A FLOW DIVERTER WITH SYMPTOMS. A FOLLOW-UP ANGIO REVEALED BLOCKAGE WITHIN THE IMPLANT. AN IA INTEGRILLIN WAS GIVEN TO THE PATIENT AND RESPONDED WELL AND WAS DISCHARGED WITH NO FURTHER SEQUELAE. DUE TO HOSPITAL POLICY, NO OTHER INFORMATION IS AVAILABLE OTHER THAN THE PATIENT IS DOING FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17997133 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A RUPTURED M3 ANEURYSM, THE PROXIMAL VASCULATURE WAS REPORTED TO BE TORTUOUS. THE FRED WAS SUCCESSFULLY DEPLOYED. THE PATIENT WAS REPORTED TO WAKE UP OKAY. APPROXIMATELY 2 HOURS POST PROCEDURE DEFICIT WAS REPORTED. A SCAN REVEALED A HUGE IPH AND WAS SENT TO THE OR FOR A STAT CRANIOTOMY. THE CAUSE OF THE IPH IS UNKNOWN. THE PATIENT WAS REPORTED 1-5-1 ON GCS AND INTUBATED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15617797 ↗