Flair® Endovascular Stent Graft FAF09040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008868), received between May 3, 2016 and Sep 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P060002); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER SUCCESSFULLY DEPLOYING THE ENDOVASCULAR STENT GRAFT IN THE RIGHT ARM AV FISTULA, THE STENT ALLEGEDLY MIGRATED BY ITSELF APPROXIMATELY 4 CENTIMETERS TOWARDS THE HAND. IT WAS REPORTED THAT THE STENT WAS DEPLOYED WITHOUT A SHEATH (BAREBACK). REPORTEDLY, THE MIGRATION OF THE STENT WAS IDENTIFIED UNDER FLUOROSCOPY, AND THE HEALTH CARE PROVIDER ATTEMPT TO PUSH THE STENT INTO PLACE DURING THE POST DILATION PROCESS UNSUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY; HOWEVER, THE PATIENT WAS RESCHEDULED TO RETURN IN A FEW MONTHS FOR OBSERVATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6860612 ↗
• MalfunctionMay 3, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT IN THE LEFT FOREARM CEPHALIC VEIN, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY MOVED TO AN UNINTENDED LOCATION. THERE WERE NO REPORTED DIFFICULTIES ADVANCING TO OR RETRACTING FROM THE LESION. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5627741 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060002. One submission often covers many models, so check the product and lot details in each record.

• Z-0223-2016 · Oct 19, 2015 · Terminated
  FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis c