Flair® Endovascular Stent Graft FAS06040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519008905), received between Oct 10, 2018 and Oct 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 10, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE FOR ARTERIAL ANASTOMOSIS OF AN UPPER ARM FISTULA, THE STENT GRAFT FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE PROXIMAL END OF THE DEVICE WAS ALLEGEDLY BROKEN. A BALLOON ANGIOPLASTY WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953586 ↗

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