Flair® Endovascular Stent Graft FAS08040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519008981), received between Dec 13, 2016 and Apr 12, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN A BASILICA VEIN FISTULA IN THE SWING POINT SECTION, THE STENT ALLEGEDLY JUMPED THREE INCHES BEYOND THE INTENDED TARGET LOCATION. ANOTHER STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509156 ↗
• MalfunctionJan 31, 2018Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE INTENDED FOR THE STENOSIS IN THE A/V FISTULA, THE WHITE HUB ALLEGEDLY DETACHED FROM THE CATHETER HANDLE PRIOR TO DEPLOYMENT ATTEMPT. REPORTEDLY, DURING AN ATTEMPT TO DEPLOY, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE ENTIRE DEVICE WAS REMOVED WITHOUT ISSUE FROM THE PATIENT AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7231491 ↗
• MalfunctionOct 9, 2017Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT WAS ALLEGEDLY DIFFICULT TO DEPLOY AND THE STENT GRAFT JUMPED APPROXIMATELY TWO INCHES WHEN IT DEPLOYED IN THE CEPHALIC VEIN. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND A SECOND STENT GRAFT WAS USED OVERLAPPING THE FIRST DEPLOYED STENT IN ORDER TO COVER THE TREATMENT AREA AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6932284 ↗
• InjuryDec 13, 2016Leak/Splash; Activation Failure; Leak/Splash; Activation Failure

  IT WAS REPORTED THAT POST DEPLOYMENT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY DID NOT FULLY EXPAND FROM THE PROXIMAL END; THEREFORE, ANOTHER STENT WAS USED AND PLACED INSIDE THE FIRST STENT GRAFT SUCCESSFULLY EXPANDED IT. IT WAS FURTHER REPORTED THAT UNDER FLUOROSCOPY, THE HEALTH CARE PROVIDER (HCP) ALLEGEDLY OBSERVED CONTRAST EXITING FROM THE PROXIMAL END OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6172642 ↗

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