Stent FREDX2518-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842429114223), received between Apr 4, 2022 and Mar 17, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: A CLOT FORMED ON THE PROXIMAL END OF THE FREDX. INTEGRILIN WAS GIVEN. THE ANEURYSM RUPTURED AND AN EVD WAS PLACED. I AM NOT AWARE OF OUTCOME.

  Patient problems: Ruptured Aneurysm; Thrombosis/Thrombus

  MAUDE report 24614237 ↗
• InjuryJun 19, 2025Entrapment of Device; Material Twisted/Bent; Migration; Entrapment of Device; Material Twisted/Bent; Migration

  IT WAS REPORTED THAT A FREDX21 STENT WAS CHOSEN TO TREAT AN A2 ANEURYSM WITH THE VESSEL SIZE MEASURING 2.39 AND 2.02. A PIPELINE WAS TRIED, BUT IT WOULDN¿T NAVIGATE TO THE TARGET SITE. THE DOCTOR THEN OPTED TO USE THE FREDX21. WHEN THIS FIRST STENT WAS DEPLOYED IN THE A2 SEGMENT, IT MIGRATED BACK TO THE A1 AFTER DEPLOYMENT. THEN, THE IMPLANTED STENT WAS CROSSED, AND A SECOND STENT WAS DEPLOYED. IT DEPLOYED NICELY UNTIL THE PROXIMAL 3RD, AND THE WHOLE SYSTEM GOT JAMMED UP AND PULLED BACK THE SECOND STENT AND MANGLED WITH THE FIRST STENT THAT MIGRATED. THERE WAS NO PATIENT INJURY REPORTED, AND THERE WERE NO ADDITIONAL SURGICAL INTERVENTIONS PERFORMED NOR REQUIRED. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290636 ↗
• InjuryMay 1, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR ATTEMPTED TO FLOW DIVERT ACOMM ANEURYSM WITH A 1.6-1.8 MM VESSEL SIZE USING A FLOW DIVERTER, AND THE DEVICE WOULD NOT OPEN. TWO ATTEMPTS WERE MADE TO RECAPTURE THE FLOW DIVERTER. ALSO, A STRETCH AND RELEASE METHOD WAS TRIED. WHEN THE FLOW DIVERTER WAS STILL HALF DEPLOYED, THE DOCTOR DID A DSA, AND THE IMAGE SHOWED A CLOT IN ACA. ASPIRATION WAS USED TO GET THE CLOT AND FLOW DIVERTER OUT OF THE ACA. THE FLOW DIVERTER WAS REMOVED FROM THE PATIENT AND DISCARDED. THE CASE WAS COMPLETED BY PLACING A SECOND STENT. THE PATIENT WAS ADMINISTERED ASPIRATION AND THROMBOLYTICS MEDICATION. THE PATIENT WAS INTACT POST-PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21946895 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FREDX21 DEVICE WAS SUCCESSFULLY IMPLANTED IN THE A2 TO TREAT A WIDE NECK ANEURYSM AND EVERYTHING LOOKED GREAT. IN PACU, THE PATIENT STARTED TO HAVE PARALYSIS ON RIGHT SIDE. INTEGRILIN WAS GIVEN BEDSIDE AND IT CLEARED UP THE CLOT. PATIENT IS NOW ASYMPTOMATIC & STABLE.

  Patient problems: Paralysis

  MAUDE report 21146221 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18969684 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVEN DAYS POST-IMPLANTATION OF A FLOW DIVERTER IN THE RIGHT PERICALLOSAL ARTERY, THE PATIENT RETURNED FOR TREATMENT OF THE RIGHT ANTERIOR COMMUNICATING ARTERY, PATIENT IS ASX, ASYMPTOMATIC. UPON INJECTION OF CONTRAST THE PHYSICIAN NOTICED BLOCKAGE OF THE STENT AND PROXIMAL AND DISTAL TO IT AFTER STENT COILING OF THE ACA ANTERIOR CEREBRAL ARTERY WITH AND LVIS. THE LVIS ACUTELY CLOTTED OFF AS WELL AS MCA MIDDLE CEREBRAL ARTERY. HEPARIN WAS ON BOARD AS WELL AS BRILINTA. IA INTEGRILLIN GIVEN FOUR TIMES. THE MD NOTED THAT CLOTTING WORSENED AFTER SUBSEQUENT INJECTION OF HEPARIN AND SUSPECTED CLOTTING DISORDER, POSSIBLY HIT. THE PATIENT AWAKENED AND WAS ABLE TO FOLLOW MOTOR COMMANDS. THE PATIENT WAS TESTED/SCREENED FOR CLOTTING DISORDERS AND TESTED POSITIVE FOR FACTOR5. THE PATIENT PASSED AWAY EIGHTEEN DAYS POST-IMPLANTATION OF THE FIRST FLOW DIVERTER CAUSED BY ISSUES UNRELATED TO THE PROCEDURE/IMPLANT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18008897 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16834381 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN PLACED THE FLOW DIVERTER FROM THE RT PCA TO THE RIGHT PCOMM AND COILED THE ANEURYSM THROUGH THE VERT. IT WAS NOTED THAT POST PROCEDURE EVERYTHING LOOKED GOOD. THE PHYSICIAN DID A FOLLOW UP A WEEK LATER AND NOTICED THROMBUS IN THE STENT AND GAVE SOME THROMBOLYTICS. THE MEDICATION CLEARED THE THROMBUS UP. THE PHYSICIAN DID THE 6 MONTH FOLLOW UP AND THE STENT WAS COMPLETELY THROMBOSED. THE PCA WAS BEING FILLED BY COLLATERALS FROM THE ACA AND MCA. THE PATIENT WAS DOING WELL, DEVICE REMAINS IMPLANTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16765645 ↗
• InjuryMar 6, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER DEPLOYING THE FLOW DIVERTER, PHYSICIAN EXPERIENCED A LOT OF RESISTANCE PULLING THE PUSHER WIRE OUT OF THE HEADWAY. IT WAS THOUGHT THAT THE PUSHER WIRE BUMPER BECAME STUCK ON THE PROXIMAL FINISHED ENDS OF THE FLOW DIVERTER. ULTIMATELY, THE SOFIA WAS BROUGHT ALL THE WAY UP, TO PULL EVERYTHING INTO THE SOFIA. THIS TOOK A FEW ATTEMPTS, AND ULTIMATELY FREED THE WIRE FROM THE FLOW DIVERTER. A TRANSFORM BALLOON WAS INFLATED FOR A FEW MINUTES AND THE BLEEDING STOPPED. THE FLOW DIVERTER DIDN¿T MOVE AND STILL COVERED THE ANEURYSM. NO REPORTED INJURY TO THE PATIENT. THE PATIENT WAS REPORTED AS OK AFTER WAKING UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487143 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM RUPTURE, A FRED DEVICE WAS IMPLANTED. A CLOT DEVELOPED INSIDE THE FRED AND FLOW WAS LOST TO THE LEFT A2. TWO DOES OF INTEGRALIN WERE ADMINISTERED. THE FRED WAS REPORTED TO SHUT DOWN AND BOTH ACA'S WERE REPORTED TO BE OCCLUDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15629458 ↗
• InjuryApr 4, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FRED X21 STENT WAS DELIVERED WITHOUT INCIDENT. INTRA-STENT THROMBUS WAS OBSERVED POST DELIVERY AND WAS RESOLVED WITH INTRA-ARTERIAL CANGRELOR AND INTEGRILIN. THERE WAS NO PATIENT HARM REPORTED, WHO WAS REPORTED TO BE DOING WELL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14003416 ↗