Stent FREDX2525-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429114230), received between Sep 9, 2022 and Jun 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A FREDX21 STENT WAS CHOSEN TO TREAT AN A2 ANEURYSM WITH THE VESSEL SIZE MEASURING 2.39 AND 2.02. A PIPELINE WAS TRIED, BUT IT WOULDN¿T NAVIGATE TO THE TARGET SITE. THE DOCTOR THEN OPTED TO USE THE FREDX21. WHEN THE FIRST STENT WAS DEPLOYED IN THE A2 SEGMENT, IT MIGRATED BACK TO THE A1 AFTER DEPLOYMENT. THEN, THE IMPLANTED STENT WAS CROSSED, AND A SECOND STENT WAS DEPLOYED. IT DEPLOYED NICELY UNTIL THE PROXIMAL 3RD, AND THE WHOLE SYSTEM GOT JAMMED UP AND PULLED BACK THE SECOND STENT AND MANGLED WITH THE FIRST STENT THAT MIGRATED. THE DOCTOR DECIDED TO LEAVE THE STENTS AS THEY WERE IMPLANTED IN THE CURRENT LOCATION. THERE WAS NO BLOOD FLOW BEING OBSTRUCTED. THE PATIENT IS ON MEDICATION AS NORMAL PROTOCOL AND IS BEING MONITOR. THE PATIENT IS PLANNING TO MAKE AN APPOINTMENT TO VISIT THE DOCTOR IN THE FUTURE. THE SECOND STENT WAS IMPLANTED IN THE PATIENT PAST ITS EXPIRATION DATE IN ERROR BY THE DOCTOR. HE WAS RECOMMENDED NOT TO USE OUR PRODUCTS PAST THE EXPIRATION DATE AND ALWAYS CHECK THE EXPIRATION DATE ON THE LABEL PRIOR TO USING OUR PRODUCTS. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312749 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A DISTAL MCA BRANCH USING A FRED X21, A BLEED OCCURRED DURING ACCESS/DEPLOYMENT OF THE DEVICE IN THE PROXIMAL ENTRY INTO THE LARGE ANEURYSM. THE VESSEL APPEARED DISEASED AT THE POINT OF THE BLEED. FAULT WAS NOT ATTRIBUTED TO THE FRED X DEVICE. A SECOND FRED X21 WAS SUCCESSFULLY PLACED INSIDE THE FIRST REPORTED FRED X21 AT THE PROXIMAL END OF THE ANEURYSM AND THE BLEED APPEARED TO DISSIPATE.

  Patient problems: Rupture

  MAUDE report 15392868 ↗