Stent FREDX3019-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842429114261), received between Oct 26, 2023 and Apr 2, 2026 — classified as 6 injuries.

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

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.

• InjuryApr 2, 2026Activation Problem

  IT WAS REPORTED THAT A STENT WAS DIFFICULT TO DETACH. EVENTUALLY IT DID DETACH BUT IT DID NOT FULLY OPEN. IT WAS REPORTED THAT THERE WAS GOOD FLOW POST DEPLOYMENT. IT WAS REPORTED THAT ABOUT A WEEK LATER THE PATIENT STARTED TO EXPERIENCE MULTIPLE STROKES. THE VESSEL WHERE THE STENT IS HAS THROMBOSIS IN THE STENT.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24769043 ↗
• InjuryApr 2, 2026Activation Problem

  IT WAS REPORTED THAT A STENT WAS DIFFICULT TO DETACH. EVENTUALLY IT DID DETACH BUT THE THE PROXIMAL END DID NOT FULLY OPEN. THE PATIENT REMAINED OVERNIGHT DUE TO THE STENT NOT COMPLETELY OPENING. NO THROMBUS WAS OBSERVED IN THE UNOPENED PORTION AND THE PATIENT WAS DISCHARGED. LATER THE PATIENT EXPERIENCED A TIA. ANGIO REVEALED THAT THE STENT IS COMPLETELY OCCLUDED DUE TO THROMBUS.

  Patient problems: Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 24767686 ↗
• InjuryJan 16, 2026Retraction Problem

  AS REPORTED, MCA ANEURYSM EMBOLIZATION. DEVICE WAS DEPLOYED SUCCESSFULLY THROUGH HEADWAY21. IT APPEARED PARTIALLY OPEN AT THE PROXIMAL END ONCE WE UNSHEATHED PAST THE DEPLOYMENT ZONE OF THE DELIVERY PUSH WIRE. WE COULD NOT DISCERN VISUALLY BUT AT LEAST ONE OF THE STRUTS DID NOT RELEASE FULLY FROM THE DEPLOYMENT WIRE/ RETAINMENT SHOULDERS OF THE DEPLOYMENT AREA. AND WHEN PULLING THE SYSTEM BACK, TO FREE IT FROM THE DEVICE PROXIMAL ZONE, IT PULLED THE ENTIRE STENT BACK TO A POOR POSITION. WE THEN WERE FORCED TO RETRIEVE THE DEVICE WITH A LOOP SNARE WHICH WE DID USING THE HEADWAY 21 AND SOFIA 5FR 125. IT WAS SUCCESSFULLY RETRIEVED AND THE PATIENT IS IN NORMAL BASELINE CONDITION. WE DID NOT TREAT THE PATIENT WITH ANY OTHER DEVICE. ADDITIONAL INFORMATION INDICATED, IT WAS DECIDED TO NOT TREAT BASED ON THE CONSIDERATION TO VESSEL INTIMA INJURY AND SUBSEQUENT REPERCUSSION FROM THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099918 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FLOW DIVERTER STENT DEVICE WAS BEING USED TO TREAT A PATIENT WITH LEFT MIDDLE CEREBRAL ARTERY ANEURYSM. A WEB EMBOLIZATION DEVICE WAS FIRST IMPLANTED, THEN THE FLOW DIVERTER STENT WAS IMPLANTED WITH MINIMAL DIFFICULTY. THE PHYSICIAN DID HAVE TO REPOSITION AS THE DEVICE WAS TOO DISTAL. AFTER REPOSITIONING THE DEVICE WAS DEPLOYED ACROSS THE ANEURYSM NECK AND DEPLOYED JUST PROXIMAL TO THE ANEURYSM WITH A PUSH OF THE LAST SEGMENT OF DEVICE FOR COMPLETE DEPLOYMENT. POST ANGIO RUN SHOWED COMPLETE OPENING OF THE DEVICE AND FILLING OF DISTAL VESSELS. AFTER THE PROCEDURE, THE PATIENT WOKE UP MOVING ALL EXTREMITIES BUT WAS SLEEPY. APPROXIMATELY ONE HOUR LATER, THE PHYSICIAN REPORTED THERE WAS CLOT IN THE DEVICE AND THE PATIENT STARTED DISPLAYING STROKE LIKE SYMPTOMS. THE PATIENT WAS BROUGHT BACK AND THE PHYSICIAN ATTEMPTED MECHANICAL THROMBECTOMY, BUT THE ASPIRATION CATHETER GOT CAUGHT ON PROXIMAL DEVICE AND PUSHED IT INTO THE ANEURYSM. THE PHYSICIAN GAVE VARIOUS MEDICATIONS (TPA, CANGRELOR, AND INTEGRILIN) THAT EVENTUALLY DISSOLVED THE CLOT. THE PATIENT WAS LEFT INTUBATED AND UNDER ANESTHETICS. UPON FOLLOW-UP, THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING A LITTL

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 21893625 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED X 21 WAS IMPLANTED FOR ANEURYSM EMBOLIZATION. STENT WAS WELL OPPOSED AND OPEN ON ANGIOGRAM. TWO (2) HOURS POST-PROCEDURE THE PHYSICIAN CALLS ME TO REPORT PATIENT'S LEFT SIDED WEAKNESS AND BRINGING BACK TO ANGIO SUITE. THROMBOLYTIC THERAPY PERFORMED. INTEGRILLIN USED. FOLLOWED UP WITH THE PHYSICIAN ONE DAY POST PROCEDURE AND HE REPORTED PATIENT'S SYMPTOMS RESOLVED AND PATIENT IS DOING WELL.

  Patient problems: Paresis

  MAUDE report 21057661 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE WHO ORIGINALLY REPORTED THE COMPLAINT, STATED THAT THE PATIENT WAS BROUGHT BACK IN FOR A CT ANGIO AND INTEGRILIN WAS GIVEN TO RESOLVE THE CLOT. THERE WAS NO REPORTED INJURY, AND THE PATIENT IS FINE.SEE H6 & H10.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18008703 ↗