Flair® Endovascular Stent Graft FAS07040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519008943), received between Mar 10, 2017 and Mar 10, 2017 — 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.

• MalfunctionMar 10, 2017Break; Migration or Expulsion of Device; Detachment of Device or Device Component; Break; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN ENDOVASCULAR STENT DEPLOYMENT PROCEDURE OF AN A/V GRAFT FOR A TIGHT LESION AT THE ANASTOMOSIS, THE STENT WAS DEPLOYED WITHOUT DIFFICULTY. HOWEVER, THE DISTAL TIP OF THE ENDOVASCULAR DEPLOYMENT SYSTEM ALLEGEDLY DETACHED DURING REMOVAL OF THE DELIVERY SYSTEM. GUIDED FLUOROSCOPY DEMONSTRATED THE DISTAL TIP IN THE PULMONARY ARTERY (PA). A SNARE DEVICE WAS ADVANCED TO THE PA; HOWEVER, FURTHER EVALUATION BY THE HEALTH CARE PROVIDER LED TO A DECISION NOT TO RETRIEVE THE DETACHED TIP. THERE WAS NO PLAN TO RETRIEVE THE DETACHED TIP. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6396469 ↗

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