Stent FRED4017-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842429106730), received between Apr 1, 2020 and Mar 19, 2021 — classified as 5 injuries, 3 malfunctions.

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 7, 2023Open, Classified

   Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

   Z-2238-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED STENT WAS IMPLANTED IN THE PATIENT FROM THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) TO AN ANEURYSM OF THE SUPRACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) TO TREAT THREE ANEURYSMS IN TANDEM: 3MM DENOVO RIGHT ICA TERMINUS ANEURYSM, 3.3MM RECURRENT RIGHT A1 SEGMENT OF ANTERIOR CEREBRAL ARTERY ANEURYSM, 2.7MM DENOVO RIGHT ANTERIOR CHOROIDAL ARTERY ANEURYSM. THE PATIENT WAS DISCHARGED HOME AND PRESCRIBED TICAGRELOR AND ASPIRIN. 11 DAYS AFTER IMPLANTATION OF THE STENT, THE PATIENT SUDDENLY DEVELOPED LEFT-SIDED WEAKNESS AND DIFFICULTY SPEAKING. THE PATIENT WAS TAKEN TO ANOTHER HOSPITAL, WHERE A CTA SHOWED THROMBOSIS OF THE RIGHT INTERNAL CAROTID ARTERY, FRED DEVICE AND RIGHT M1 SEGMENT OF THE MCA. NO INTERVENTION WAS UNDERTAKEN. THE PATIENT IS WHEELCHAIR BOUND 1 YEAR AFTER THE EVENT (MODIFIED RANKIN SCALE 4).

  Patient problems: Muscle Weakness/Atrophy; Obstruction/Occlusion; Speech Disorder; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11530686 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A FRED STENT TO TREAT A 4.7MM RIGHT SUPERIOR HYPOPHYSEAL ARTERY ANEURYSM, A 2.4MM RIGHT LATERAL PARACLINOID INTERNAL CAROTID ARTERY (ICA) ANEURYSM, AND A 2.4MM RIGHT CAVERNOUS ICA ANEURYSM, THE PATIENT AWOKE FROM ANESTHESIA AND BEGAN TO EXPERIENCE A TEN MINUTE EPISODE OF LEFT ARM AND LEFT LEG WEAKNESS. A CT SHOWED NO HEMORRHAGE AND CTA SHOWED NO LARGE VESSEL OCCLUSION. THERE WAS NO THROMBUS IDENTIFIED IN THE PATIENT, BUT THE PHYSICIAN DID DEEM IT TO BE A THROMBOEMBOLIC EVENT. THE PATIENT'S PLATELET REACTIVITY UNITS (PRU) WERE MEASURE AT 189 AND THEIR TICAGRELOR DOSE WAS INCREASED TO 180MG, AFTER WHICH THE SYMPTOMS RESOLVED. THE PATIENT REMAINS NEUROLOGICALLY INTACT ONE YEAR AFTER TREATMENT.

  Patient problems: Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 11520817 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE FRED TO TREAT BILATERAL PARAOPHTHALMIC ANEURYSMS, THROMBUS WAS IDENTIFIED IN THE DISTAL END OF THE STENT. AGGRASTAT AND NITRO WERE ADMINISTERED TO THE PATIENT, WHICH RESTORED FLOW TO THE ACA. POST-PROCEDURE, THE PATIENT AWOKE WITH NO DEFICIT. THERE WAS NO REPORTED SEQUELA.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11325760 ↗
• MalfunctionJan 9, 2021Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT A MONTH AFTER THE FRED WAS IMPLANTED, THE STENT WAS NOTED TO BE COMPRESSED AND HAD MOVED FROM THE INITIAL PLACEMENT SITE, AND WAS NO LONGER COVERING THE ANEURYSM NECK. NO INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143980 ↗
• MalfunctionJun 25, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT APPROXIMATELY 25% OF THE STENT COULD NOT BE RECAPTURED BY THE MICROCATHETER. THE STENT AND MICROCATHETER WERE WITHDRAWN TOGETHER INTO THE INTERMEDIATE SUPPORT CATHETER AND REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S FINAL CONDITION WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197775 ↗
• MalfunctionJun 24, 2020Retraction Problem; Activation Failure; Retraction Problem; Activation Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE FRED DID NOT OPEN AROUND A TURN IN THE VESSEL AFTER APPROXIMATELY 20-30% OF THE FRED HAD BEEN DEPLOYED. THE FRED WAS THEN UNABLE TO BE RESHEATHED BACK INTO THE MICROCATHETER. THE PARTIALLY OPEN STENT WAS REMOVED TOGETHER WITH THE MICROCATHETER FROM THE PATIENT THROUGH THE INTERMEDIATE SUPPORT CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT WAS DISCHARGED HOME AND REPORTED TO BE STABLE AND NEUROLOGICALLY INTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10192992 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE FRED ACROSS AN ANEURYSM IN THE DISTAL INTERNAL CAROTID ARTERY (ICA), IMAGES DEMONSTRATED SMALL CLOT AGGREGATION AROUND THE DISTAL END OF THE FRED. REOPRO WAS ADMINISTERED, WHICH RESOLVED THE CLOT. THE PATIENT WOKE UP NEUROLOGICALLY INTACT. THERE WAS NO REPORTED CLINICAL SEQUELA.

  Patient problems: Thrombus

  MAUDE report 9925557 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS ANEURYSM. THE FRED WAS SUCCESSFULLY PLACED AT THE TREATMENT SITE WITHOUT INCIDENT AND IMMEDIATE ANGIOGRAMS DEMONSTRATED A PATENT FRED. AFTER COMPLETION OF THE CASE, THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS AND SPEECH DIFFICULTIES, AND WAS RETURNED FOR ANOTHER ANGIOGRAM, WHICH DEMONSTRATED AN OCCLUDED FRED. THROMBUS WAS ASPIRATED THROUGH AN INTERMEDIATE CATHETER AND BALLOON ANGIOPLASTY WAS PERFORMED WITHIN THE FRED, WHICH RESTORED VESSEL PATENCY. POST-PROCEDURE IMAGES CONFIRMED A PATENT LEFT ICA, LEFT MIDDLE CEREBRAL ARTERY, AND FRED. THE PATIENT WAS REPORTED TO BE NEARLY BACK TO BASELINE NEURO STATUS ON (B)(6) 2020.

  Patient problems: Brain Injury; Thrombus; Weakness

  MAUDE report 9914518 ↗