Flair® Endovascular Stent Graft FAS09050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04049519009032), received between Sep 20, 2016 and Apr 13, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2020Break; Positioning Failure; Break; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS09050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED BREAK AND FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954690 ↗
• MalfunctionOct 15, 2019Break; Positioning Failure; Break; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS09050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A BREAK AND FAILED TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE 50 YEAR OLD MALE PATIENT¿S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193015 ↗
• MalfunctionJul 11, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS09050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A DEPLOYMENT ISSUE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCE. THE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD MALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783201 ↗
• MalfunctionDec 28, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE INTENDED FOR THE PROXIMAL FISTULA, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY DUE TO A BREAK OF THE OUTER CATHETER CONNECTED TO THE HANDLE. REPORTEDLY, PATIENT EXPERIENCED ADDITIONAL BLEEDING AT THE ACCESS SITE AND WAS STABLE AFTER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT IS CURRENTLY STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151174 ↗
• MalfunctionOct 17, 2017Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR STENT GRAFT PLACEMENT PROCEDURE IN THE BRACHIAL CEPHALIC VEIN VIA THE RIGHT UPPER ARM, LOOP GRAFT, THE STENT GRAFT WAS ALLEGEDLY UNABLE TO DEPLOY AND THE OUTER CATHETER SHEATH ALLEGEDLY FRACTURED. THE DELIVERY SYSTEM WAS REPORTEDLY REMOVED WITHOUT ISSUES AND EXCHANGED FOR ANOTHER IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6956653 ↗
• MalfunctionOct 16, 2017Bent; Break; Positioning Failure; Fracture; Bent; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR STENT GRAFT PLACEMENT PROCEDURE IN THE BRACHIAL CEPHALIC VEIN VIA THE RIGHT UPPER ARM, LOOP GRAFT, THE STENT GRAFT WAS ALLEGEDLY UNABLE TO DEPLOY AND THE OUTER CATHETER SHEATH ALLEGEDLY FRACTURED. THE DELIVERY SYSTEM WAS REPORTEDLY REMOVED WITHOUT ISSUES AND EXCHANGED FOR ANOTHER IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6953143 ↗
• MalfunctionAug 24, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY IN A PSEUDO ANEURYSM IN THE BASILIC BRACHIAL VEIN. REPORTEDLY, ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819199 ↗
• MalfunctionSep 20, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM OUTER CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE GRAFT DELIVERY SYSTEM. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT WAS USE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5964586 ↗

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