Stent FRED5514-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429106853), received between Apr 2, 2020 and Aug 26, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Activation Failure” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

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.

• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A FRED STENT WAS IMPLANTED IN A PATIENT ON (B)(6) 2020, THE PATIENT PRESENTED TO THE HOSPITAL WITH STROKE-LIKE SYMPTOMS ON (B)(6) 2021. THERE WAS A COMPLETE OCCLUSION OF THE INTERNAL CAROTID ARTERY. THE PATIENT WAS ON ASA AND PLAVIX FOR 3 MONTHS POST PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 12370807 ↗
• InjuryMay 1, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT A FRED STENT DID NOT FULLY OPEN AFTER BEING IMPLANTED IN THE PATIENT. A BALLOON CATHETER WAS THEN USED TO FULLY OPEN THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758658 ↗
• InjuryDec 16, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED, THE STENT DID NOT APPEAR TO BE COMPLETELY OPEN AT THE PROXIMAL END, WHICH LIMITED FLOW. A BALLOON INFLATION WAS PERFORMED AND FLOW WAS RESTORED. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT IS CURRENTLY REPORTED TO BE "OKAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024562 ↗
• InjuryOct 9, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED, THE MIDDLE OF THE STENT DID NOT COMPLETELY OPEN AROUND A CURVE IN THE VESSEL. THE STENT WAS RETRIEVED FROM THE PATIENT WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS CURRENTLY REPORTED TO BE "FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10659798 ↗
• InjuryApr 2, 2020Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT AFTER THE FRED HAD BEEN DEPLOYED IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA), PART OF THE STENT DID NOT APPEAR TO BE OPENED. A WIRE, MICROCATHETER, AND A GUIDE CATHETER WERE USED TO OPEN THE STENT. INTEGRILIN WAS ADMINISTERED TO THE PATIENT DURING THE PROCEDURE. UPON CLOSER INSPECTION POST-PROCEDURE, THE IMPLANTED STENT APPEARED TO BE TWISTED IN THE PROXIMAL SEGMENT. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918024 ↗