Stent FRED3014-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429106624), received between Apr 3, 2020 and Jan 11, 2022 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE FRED JR STENT DID NOT FULLY OPEN OR OPPOSE VESSEL WALL IN PROXIMAL PART OF THE STENT. THE FLARED ENDS OF PROXIMAL PART OF STENT WERE OPEN, BUT IT WAS PINCHED DOWN AND NOT FULLY OPEN AFTER DETACHMENT. CLOT FORMED 2 MINUTES AFTER DEPLOYMENT, AFTER THE PUSHER WAS PULLED OUT AND THE MICROCATHETER WAS PULLED BACK A LITTLE. INTEGRILLIN WAS GIVEN AND PATIENT WILL STAY ON INTEGRILLIN FOR NOW. PATIENT WAS HELD AT HOSPITAL FOR A FEW EXTRA DAYS FOR OBSERVATION, THEN DISCHARGED AND WAS DOING "PRETTY WELL". PATIENT WAS BROUGHT BACK ON JANUARY 6TH FOR ANOTHER ANGIOGRAM AND FURTHER TREATMENT WAS NOT NEEDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13232432 ↗
• InjuryMar 25, 2021Activation Failure; Difficult or Delayed Separation; Activation Failure; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE PROXIMAL PORTION OF A FRED STENT DID NOT OPEN PROPERLY. THE DELIVERY PUSHER THEN GOT CAUGHT IN ONE OF THE FLARED ENDS OF THE STENT. THE FRED DEVICE WAS SNARED AND REMOVED. ANOTHER FRED DEVICE WAS THEN USED TO TREAT THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR FURTHER INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573146 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN A-COM ANEURYSM ON (B)(6) 2020. THE FRED WAS IMPLANTED IN A SATISFACTORY POSITION WITHOUT INCIDENT AND THE PATIENT WAS DISCHARGED HOME. THREE DAYS POST-PROCEDURE ON (B)(6) 2020, THE PATIENT PRESENTED WITH STROKE SYMPTOMS AND A CLOT WAS IDENTIFIED WITHIN THE FRED. THE PATIENT WAS TAKEN TO THE INTERVENTIONAL RADIOLOGY LAB LAB FOR AN ANGIOGRAM AND TREATED WITH INTRA-ARTERIAL THROMBOLYSIS MEDICATIONS. THE CURRENT PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Thrombus

  MAUDE report 9925570 ↗