Stent FREDX4520-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00842429114407), received between Jun 23, 2022 and Sep 5, 2026 — classified as 1 death, 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2026Activation Failure

  Patient problems: Stenosis

  MAUDE report 50624980 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY, EVENT #4, ASYMPTOMATIC OPHTHALMIC ARTERY OCCLUSION. EVENT START DATE : (B)(6) 2024. SEVERITY : MILD. WAS THIS A SERIOUS AE? : NO. WAS THE AE CAUSED BY OR ASSOCIATED WITH A TECHNICAL EVENT? : NO. RELATIONSHIP TO STUDY DEVICE: PROBABLE. RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: PROBABLE. RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED. RELATIONSHIP TO STUDY DISEASE: POSSIBLE. RELATIONSHIP TO CONCOMITANT DISEASE: POSSIBLE. AE OUTCOME: ONGOING. ADDITIONAL INFORMATION INDICATED: TREATMENT SITE: RIGHT CAROTID OPHTHALMIC ANEURYSM INDEX PROCEDURE PERFORMED: (B)(6) 2024. DURING THE STUDY PROCEDURE, TWO FREDX DEVICES WERE USED TO COVER THE ANEURYSM NECK. THE PARTICIPANT PRESENTED ON (B)(6) 2024 FOR A REGULAR SCHEDULED 6M FU IMAGING. IT WAS DURING THIS FU IMAGING THAT THE ASYMPTOMATIC OCCLUSION WAS FIRST SEEN ON (B)(6) 2024. NO ACTION/ INTERVENTION TAKEN AS PARTICIPANT IS ASYMPTOMATIC.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24533337 ↗
• InjuryDec 21, 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, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IMAGING AT ONE YEAR FOLLOW-UP NOTED RESIDUAL ANEURYSM. THE SUBJECT WAS REPORTED TO BE ASYMPTOMATIC AND THERE WAS NO CHANGE TO NEURO STATUS. THE DECISION WAS MADE TO RE-TREAT THE PATIENT AT A LATER DATE.

  Patient problems: Aneurysm expansion

  MAUDE report 23860447 ↗
• DeathOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MICROVENTION THAT DURING DEPLOYMENT OF A FRED X, A RUPTURE OCCURRED IN THE POSTERIOR COMMUNICATING ARTERY (PCA). ALLEGEDLY, THE CASE WAS PLANNED TO TREAT A RESIDUAL NECK OF AN ANEURYSM THAT WAS PREVIOUSLY COILED (6 MONTHS AGO). IT WAS REPORTED THAT THE PATIENT HAD COMPLICATED AND TORTUOUS ANATOMY/VASCULATURE. IT WAS REPORTED THAT POSTOPERATIVELY, THE FRED X HAD MOVED INTO THE PCA, EVEN THOUGH IT WAS NOT VISUALIZED AS HAVING MOVED PRIOR TO THE PLANNED DEPLOYMENT IN THE INTERNAL CAROTID ARTERY (ICA). REPORTEDLY, THE PHYSICIAN IMMEDIATELY BEGAN COILING THE DISTAL END OF THE FRED X AND THEN INJECTED LIQUID EMBOLIC TO SEAL OFF THE AREA OF THE HEMORRHAGE. FOUR COILS WERE USED TO TREAT THE HEMORRHAGE. THE POSTOPERATIVE SCAN INDICATED THAT THE PATIENT HAD A HEMATOMA IN THE AREA TREATED. IT WAS LATER REPORTED THAT THE PHYSICIAN SUCCESSFULLY EVACUATED THE HEMATOMA FROM THE AREA ON THE SAME DAY OF THE SURGERY. IT WAS REPORTED THAT THE PATIENT NEVER REGAINED CONSCIOUSNESS. SUBSEQUENTLY, THE PATIENT EXPIRED. THE OFFICIAL CAUSE OF DEATH IS UNKNOWN. NO IMAGING WAS PROVIDED.

  Patient problems: Hematoma; Obstruction/Occlusion; Perforation of Vessels

  MAUDE report 23275008 ↗
• InjurySep 12, 2025Activation Problem; Activation Problem

  AS REPORTED: DEVICE OPENED DISTALLY BUT AS WE CAME TO DEPLOY PROXIMALLY IT DID NOT OPEN LIKE WE HAD EXPECTED, WE ATTEMPTED TO GAIN ACCESS THROUGH LUMEN OF DEVICE WITH A WIRE BUT COULD NOT, WE USED A SNARE TO RETRIEVE THE DEVICE AND PLACED A WEB DEVICE. GOOD PATIENT OUTCOME. ANEURYSM TREATED AND DISCHARGED FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035000 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FRED X PAS CLINICAL STUDY THAT 6-MONTH ANGIOGRAM COMPLETED BY THE PHYSICIAN DEMONSTRATED AN INCREASE IN SIZE OF AN IRREGULAR LEFT OPHTHALMIC ANEURYSM. THE PHYSICIAN WAS PLANNING FOR ADDITIONAL INDEX ANEURYSM RETREATMENT PROCEDURE ON (B)(6) 2025; HOWEVER, AT THE TIME OF THIS REPORT, IT IS UNCONFIRMED IF THE RETREATMENT WAS PERFORMED. EVENT ASSESSED AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. PATIENT CURRENT STATUS INDICATED AS: MRS 0 AND NIHSS 0.

  Patient problems: Aneurysm expansion

  MAUDE report 21724529 ↗
• InjuryJan 16, 2025Difficult or Delayed Positioning; Activation Problem; Difficult or Delayed Positioning; Activation Problem

  IT WAS REPORTED THAT A FREDX WAS CHOSEN FOR TREATMENT OF A CAVERNOUS RIGHT ICA ANEURYSM. DURING THE PRE-PROCEDURAL PLAN, REPRESENTATIVE INDICATED THAT A LONGER DEVICE THAN THE PHYSICIAN SELECTED WOULD BE APPROPRIATE. PHYSICIAN SELECTED A SHORTER DEVICE. DURING DEPLOYMENT, THE DEVICE WAS RE-SHEATHED TWICE TO POSITION THE DISTAL END MORE PROXIMAL IN THE ICA TO AVOID A POTENTIAL 'LEDGE' EFFECT WITH DEPLOYMENT ON A CURVE. WHEN REACHING THE END OF THE STENT DEPLOYMENT, IT WAS OBSERVED THAT THE STENT WAS NOT FULLY OPENED. WHILE ATTEMPTING TO RECAPTURE THE STENT, THE STENT WAS PARTIALLY DEPLOYED WITH 2 PROXIMAL TINES DEPLOYED AND 2 TINES STILL INSIDE OF THE BUMPERS WITH THE MICROCATHETER OVER THE PROXIMAL END OF THE STENT. DURING THAT TIME THE PHYSICIAN THEN ADVANCED THE MICROCATHETER, CAUSING THE STENT TO ¿STACK¿ OVER THE ANEURYSM NECK. IT WAS NOTED THAT THE PROXIMAL END OF THE STENT WOULD BE DIFFICULT TO OPEN FOLLOWING THAT MANEUVER. THE STENT HAD BEEN COMPLETELY DETACHED AT SOME POINT DURING DEPLOYMENT, SO THE DECISION WAS THEN MADE TO USE A SNARE TO RECAPTURE THE FREDX DEVICE AND REMOVE IT. THE CASE WAS ENDED WITH NO TREATMENT OF THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165385 ↗
• MalfunctionSep 24, 2024Activation Problem; Activation Problem

  PLEASE SEE SECTION H11 FOR INVESTIGATION RESULTS OF CUSTOMER PROVIDED IMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297545 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF FRED INTO DESIRED LOCATION, SUBSEQUENT ANGIOGRAPHY WAS PERFORMED TO ASSESS STENT PLACEMENT AND ANEURYSM MORPHOLOGY. THE PHYSICIAN NOTED THAT THERE WAS SIGNIFICANT STAGNATION AND DECIDED TO GIVE SYSTEMIC INTEGRILIN TO AVOID IN STENT THROMBOSIS. ANGIOGRAPHY WAS THEN PERFORMED ON THE CONTRALATERAL AND POSTERIOR CIRCULATIONS TO ASSESS NEUROVA SCULATURE IN OTHER TERRITORIES. ONCE COMPLETED, THE RIGHT ICA WAS RE-CATHETERIZED TO REASSESS STENT AND THROMBUS WAS NOTED IN THE STENT, ON THE PROXIMAL END. AN ADDITIONAL BOLUS OF INTEGRILIN WAS GIVEN AND ANGIOGRAPHY WAS PERFORMED AROUND 10- AND 20-MINUTES POST INTEGRILIN. SOME IMPROVEMENT WAS NOTED, BUT THERE STILL APPEARED TO BE RESIDUAL CLOT INSIDE OF THE STENT. THE PHYSICIAN DECIDED IT TO PLACE A NEUROFORM ATLAS STENT INSIDE OF THE FREDX. THE PATIENT HAD NO NEUROLOGICAL DEFICITS POST PROCEDURE. DESCRIPTION OF INTERVENTION: MEDICINAL IV/IA ANTI-PLATELET INJECTIONS ADJUNCTIVE STENT PLACEMENT INSIDE OF FREDX DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20285822 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE FRED X PAS CLINICAL STUDY: CLOT FORMATION WITHIN THE FRED X DEVICE. ON POST INTERVENTION IMAGING NON-FLOW LIMITING CLOT FORMATION WAS NOTED IN THE FRED X DEVICE. ANTI-COAGULANT DRIP WAS STARTED, FOLLOWED BY A BOLUS. WHEN THE ISSUE DID NOT RESOLVE, A COMPETITOR'S STENT WAS DEPLOYED WITHIN THE FRED X AND EXTENDING BOTH DISTALLY AND PROXIMALLY. POST DEPLOYMENT OF AN OVERLAPPING COMPETITOR'S STENT TO TREAT CLOT FORMATION WITHIN THE FRED X, A CAROTID STENT WAS PLACED TO TREAT AN AREA OF DISSECTION IN THE R ICA PROXIMAL TO THE TARGET ANEURYSM. TACHYCARDIC DURING PROCEDURE WITH FLUCTUATING/DOWNTRENDING BLOOD PRESSURE REQUIRING PRESSOR SUPPORT, WAS TREATED WITH MEDICATION. EVENT WAS RESOLVED WITHIN THE SAME DAY. THE CLOT FORMATION WAS ASSESSED BY THE SITE AS PROBABLY RELATED TO THE STUDY DEVICE, FRED X.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20208463 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY FRED X PAS, THIS SUBJECT HAD AE1: PARESTHESIA REPORTED AT THE 6-MONTH FU VISIT BUT IMAGING RULED OUT ANY RELATIONSHIP TO DEVICE AND PROCEDURE. NEW NUMBNESS AND TINGLING IN LEFT UPPER EXTREMITY AND LEFT LOWER EXTREMITY. AE1 WAS STATED TO BE POSSIBLY RELATED TO STUDY DEVICE/PROCEDURE AND POSSIBLY TO CONCOMITANT DISEASE. (PATIENT HAS A HISTORY OF TENNIS ELBOW AND LEFT ANKLE HARDWARE IN PLACE FROM FRACTURE OF ANKLE). HOWEVER, AT THE 1-YR FU IMAGING ON (B)(6) 2024, AE2: COMPLETE ARTERY OCCLUSION WAS REPORTED. THE SITE THEN UPDATED THE 6-MONTH FU IMAGING VISIT TO REPORT THE COMPLETE ARTERY OCCLUSION AND ALSO REPORTED THE AE2: COMPLETE ARTERY OCCLUSION START DATE AS (B)(6) 2023 AND WAS STATED TO BE POSSIBLY RELATED TO STUDY DEVICE, PROCEDURE, AND STUDY DISEASE. IT WAS REPORTED THAT THE PATIENTS MRS AND NIHSS AT 1-YR FU ON (B)(6) 2024 WAS 0. THE AE2 WAS RESOLVED ON (B)(6) 2023. THERE ARE NO PLANS FOR FOLLOW UP TREATMENT.

  Patient problems: Obstruction/Occlusion; Paresthesia

  MAUDE report 19570889 ↗
• MalfunctionJun 23, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A RUPTURED ICA ANEURYSM, AN INCOMPLETELY EXPANDED FLOW DIVERTER WAS DEPLOYED, AND THE PHYSICIAN WAS UNABLE TO REMOVE IT DESPITE ATTEMPTS. THE PATIENT PRESENTED WITH A BLEED FROM A DAUGHTER SAC THAT FORMED NEXT TO A THREE-YEAR-OLD PREVIOUSLY COIL EMBOLIZED LOBE ANEURYSM. AFTER A WOVEN ENDOBRIDGE INTRASACCULAR DEVICE WAS SUCCESSFULLY DEPLOYED IN THE DAUGHTER SAC, A FLOW DIVERTER WAS IMPLANTED. THE FLOW DIVERTER EXPERIENCED RESISTANCE IN THE HUB OR PROXIMAL PORTION OF THE MICROCATHETER PRIOR TO EXITING THE MICROCATHETER. THE PHYSICIAN OPTED TO USE THE DEVICE DESPITE THE RECOMMENDATION TO REPLACE IT. UPON DEPLOYMENT, IT WAS NOTED THAT THE MID-SECTION WAS NOT OPEN. MULTIPLE ATTEMPTS TO SNARE THE FLOW DIVERTER WITH TWO DIFFERENT SNARES WERE UNSUCCESSFUL. ATTEMPTS TO ACCESS THE TREATMENT AREA AND ACCESS THE DEVICE USING OTHER DEVICES WERE NOT SUCCESSFUL AS THEY COULD NOT ADVANCE PAST THE PROXIMAL CURVE. THE DEVICE IS IMPLANTED IN THE PATIENT. THE PATIENT WAS REPORTED AS INTUBATED AND SEDATED FROM THE BLEED. THE PATIENT WAS REPORTED TO BE MAKING "SLOW IMPROVEMENTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14793343 ↗