Stent FRED4528-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429106792), received between Aug 13, 2020 and Apr 5, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Activation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT A FRED FLOW DIVERTER WAS IMPLANTED TO TREAT AN ICA ANEURYSM. IT WAS NOTICED THAT THE FLOW IN THE VESSEL WAS SLOW. A WIRE WAS USED TO OPEN THE STENT COMPLETELY AND SOME THROMBUS WAS OBSERVED. THE STENT WAS THEN REMOVED WITH A SNARE. ANOTHER STENT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE AND THE PATIENT IS REPORTED TO BE "DOING WELL."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14018070 ↗
• InjuryJun 9, 2021Separation Failure; Activation Failure; Separation Failure; Activation Failure

  IT WAS REPORTED THAT A FLOW DIVERTER DEVICE (FRED 27 STENT) USED FOR TREATMENT OF A PARACLINOID ANEURYSM WOULD NOT RELEASE FROM THE DELIVERY PUSHER WIRE. THE FLARED ENDS OF THE STENT WERE OPEN JUST ENOUGH TO BE LOOSE FROM THE PUSHER WIRE BUT THE STENT WOULD NOT OPEN FULLY. A SNARE WAS USED TO REMOVED THE DEVICE WITHOUT ANY ISSUE AND THE CASE WAS ENDED WITHOUT TREATMENT OF THE ANEURYSM. THE PATIENT SUFFERED NO CONSEQUENCES DUE TO THE PROCEDURE OR POST PROCEDURE AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971327 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED WAS SUCCESSFULLY IMPLANTED TO TREAT AN ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY. TWO WEEKS POST-PROCEDURE, THROMBUS WAS IDENTIFIED WITHIN THE STENT AND A THROMBECTOMY WAS ATTEMPTED, WITHOUT SUCCESS. THERE WAS NO REPORTED DEVICE MALFUNCTION. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH THE POST-PROCEDURE DUAL ANTI-PLATELET MEDICATION. THE PATIENT IS BEING MANAGED MEDICALLY. THERE WAS NO REPORTED SEQUELA.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11319057 ↗
• InjurySep 15, 2020Activation Failure; Activation Failure

  UPON DEPLOYMENT OF THE FRED DEVICE TO TREAT A DISSECTING ANEURYSM (DA) OF AN INTERNAL CAROTID ARTERY, THE DEVICE REPORTEDLY OPENED PARTIALLY. A BALLOON CATHETER WAS DEPLOYED TO SUCCESSFULLY EXPAND THE STENT TO FULL OPENING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538420 ↗
• InjuryAug 13, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED, THE FLOW DIVERTER WAS NOT COMPLETELY APPOSED AROUND THE SYPHON IN TWO LOCATIONS AND THROMBUS DEVELOPED. A MICROWIRE WAS USED TO ENCOURAGE STENT APPOSITION; HOWEVER, THE STENT FORESHORTENED AFTER THE MANIPULATIONS WITH THE WIRE, AND THROMBUS FORMED WITHIN THE PROXIMAL PORTION OF THE FRED WHERE THE WORKING LENGTH BEGINS AND OUTSIDE THE STENT IN THE AREAS OF MALAPPOSITION. INTEGRILIN WAS DELIVERED TO THE PATIENT AND THE THROMBUS RESOLVED IN ALL LOCATIONS EXCEPT AT THE PROXIMAL PORTION OF THE DEVICE WHERE CT IMAGES SUGGEST THE STENT IS BUNCHED ALONG THE HORIZONTAL CAVERNOUS SEGMENT. ALL OTHER VESSELS WERE PATENT, POST-PROCEDURE. THE PATIENT MOVED ALL EXTREMITIES AFTER WAKING FROM ANESTHESIA. THE PATIENT IS REPORTED TO BE CLINICALLY STABLE AND NEUROLOGICALLY INTACT WITH NO SEQUELA.

  Patient problems: Thrombus

  MAUDE report 10405015 ↗