Flair® Endovascular Stent Graft FAS07050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04049519008950), received between Jan 8, 2016 and Jan 10, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionJan 10, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE TO TREAT ANASTOMOSIS OF A GRAFT IN THE LEFT UPPER EXTREMITY, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8236358 ↗
• MalfunctionSep 18, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED UPON REMOVING THE STENT GRAFT, A BREAK WAS IDENTIFIED ON THE CATHETER. NO FURTHER TREATMENT WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887595 ↗
• MalfunctionAug 13, 2018Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  IT WAS REPORTED THAT DURING PLACEMENT OF THE VASCULAR STENT GRAFT IN THE LOOP GRAFT, THE STENT GRAFT WAS NOT ALLEGEDLY DEPLOYED IN INTENDED PLACEMENT SITE. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND A SECOND ENDOVASCULAR STENT GRAFT WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779255 ↗
• MalfunctionSep 29, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY PREMATURELY DEPLOYED AS THE DELIVERY SYSTEM WAS BEING ADVANCE TO THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906250 ↗
• MalfunctionSep 23, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT ALLEGEDLY COULD NOT BE DEPLOYED AND THE OUTER CATHETER SUBSEQUENTLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5975389 ↗
• MalfunctionAug 3, 2016Break; Break

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY IN THE BASILIC VEIN DURING TREATMENT OF AN AV GRAFT. IT WAS FURTHER REPORTED THAT THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM OUTER CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. 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 5845551 ↗
• MalfunctionMar 8, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING USE IN AN A/V GRAFT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE SYSTEM WAS RETRACTED WITHOUT INCIDENT AND ANOTHER ENDOVASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5486339 ↗
• MalfunctionJan 8, 2016Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE OUTER GRAY CATHETER BROKE. IT WAS THEN REPORTED THAT THE DEVICE WAS RETRACTED WITHOUT INCIDENT AND 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 5355331 ↗

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