Stent FRED3021-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429106631), received between Jul 24, 2020 and May 26, 2021 — classified as 3 injuries, 1 malfunction.

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

• InjuryMay 26, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE FRED FLOW DIVERTER STENT WAS USED IN THE PATIENT TO TREAT PREVIOUSLY DEPLOYED EMBOLIZATION DEVICE FROM A DIFFERENT MANUFACTURER THAT MIGRATED AND RESULTED IN AN ENDOLEAK. THE FRED WAS PLACED THROUGH THE EMPOLIZATION DEVICE FROM A2 TO A1 SEGMENT. ANGIOGRAM RUN IMMEDIATELY AFTER DEPLOYMENT LOOKED GOOD, BUT LATER RUNS SHOWED SLOW FLOW BACK THROUGH THE VESSEL. DISTAL END OF FRED LOOKED NARROW UPON IMAGING REVIEW. CROSSING THE FRED WAS ATTEMPTED WITH A WIRE; HOWEVER, A MICROCATHETER COULD NOT INITIALLY CROSS. EVENTUALLY A BALLOON CATHETER WAS SUCCESSFULLY ADVANCED INTO THE FRED AND INFLATED IN THE DISTAL END RESULTING IN RESTORATION OF NORMAL FLOW. THE PATIENT WAS STABLE AND AWAKE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891040 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 HOURS AFTER IMPLANTATION OF THE FRED IN THE SUPRACLINOID SEGMENT OF THE ICA, THROMBUS WAS IDENTIFIED IN THE ARTERY. THE PATIENT EXPERIENCED DYSARTHRIA. REOPRO AND HEPARIN WERE ADMINISTERED TO THE PATIENT. THERE WAS NO REPORTED MALFUNCTION OF THE FRED.

  Patient problems: Speech Disorder; Thrombosis/Thrombus

  MAUDE report 11042424 ↗
• InjuryOct 23, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE FRED JR, THE DISTAL END OF THE STENT PULLED BACK "INTO THE DEPLOYMENT." CONTRAST EXTRAVASATION WAS OBSERVED. THE FRED WAS RESHEATHED AND REMOVED, HEPARIN WAS REVERSED, AND THE ANEURYSM WAS COILED. THE EXTRAVASATION WAS RESOLVED. AN EVD WAS PLACED. FOLLOW-UP CT SHOWED THE BRAIN WAS "NORMAL," HOWEVER, A TRACT HEMORRHAGE WAS NOTED FROM THE EVD PLACEMENT.

  Patient problems: Extravasation

  MAUDE report 10731620 ↗
• MalfunctionJul 24, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THE ORIGIN OF THE ACOM COMPLEX WAS REPORTED TO BE SLIGHTLY TORTUOUS WITH SOME NARROWING NEAR THE NECK OF THE ANEURYSM. AFTER PLACEMENT OF THE FRED BETWEEN THE A2 AND A1 SEGMENT, THE PUSHER WIRE CAUGHT ON THE STENT DURING THE REMOVAL ATTEMPT. THE INTERMEDIATE CATHETER WAS ADVANCED AND USED TO DETACH THE STENT FROM THE PUSHER WIRE AND MICROCATHETER. AFTER DEPLOYMENT, THE FRED SLIGHTLY EXTENDED INTO THE INTERNAL CAROTID ARTERY. THE STENT REMAINS IMPLANTED. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10320702 ↗