Flair® Endovascular Stent Graft FAS09040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519009025), received between Dec 22, 2016 and Dec 22, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2016Bent; Positioning Failure; Retraction Problem; Bent; Positioning Failure; Retraction Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR STENT GRAFT DEPLOYMENT PROCEDURE IN THE LEFT UPPER ARM A/V FISTULA, THE STENT GRAFT ALLEGEDLY COULD NOT BE DEPLOYED. THE HEALTHCARE PROVIDER (HCP) ALLEGED DIFFICULTY RETRACTING THE DELIVERY SYSTEM THROUGH THE SHEATH. UPON RETRACTION OF THE SYSTEM, A BENT WAS ALLEGEDLY IDENTIFIED BETWEEN THE STENT AND THE CATHETER. REPORTEDLY, ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6199752 ↗

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